NCT05751135

Brief Summary

This study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. A qualitative gait analysis will also be done.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

February 20, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

Cerebral palsyFocal muscle vibrationBiopsychosocialFunctional near-infrared spectroscopyElectroencephalographyEmotional reactivity

Outcome Measures

Primary Outcomes (78)

  • Functional near-infrared spectroscopy (fNIRS)

    Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.

    Baseline

  • Functional near-infrared spectroscopy (fNIRS)

    Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.

    After 4 weeks

  • Functional near-infrared spectroscopy (fNIRS)

    Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.

    After 8 weeks

  • Electroencephalogram (EEG)

    The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.

    Baseline

  • Electroencephalogram (EEG)

    The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.

    After 4 weeks

  • Electroencephalogram (EEG)

    The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.

    After 8 weeks

  • Gross Motor Function Measure

    Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity

    Baseline

  • Gross Motor Function Measure

    Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity

    After 4 weeks

  • Gross Motor Function Measure

    Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity

    After 8 weeks

  • Gross Motor Function Measure

    Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity

    After 12 weeks

  • Modified Ashworth scale

    It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension

    Baseline

  • Modified Ashworth scale

    It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension

    After 4 weeks

  • Modified Ashworth scale

    It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension

    After 8 weeks

  • Modified Ashworth scale

    It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension

    After 12 weeks

  • Child Behavior Checklist (CBCL)

    The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.

    Baseline

  • Child Behavior Checklist (CBCL)

    The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.

    After 4 weeks

  • Child Behavior Checklist (CBCL)

    The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.

    After 8 weeks

  • Child Behavior Checklist (CBCL)

    The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.

    After 12 weeks

  • Social support questionnaire

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

    Baseline

  • Social support questionnaire

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

    After 4 weeks

  • Social support questionnaire

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

    After 8 weeks

  • Social support questionnaire

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

    After 12 weeks

  • Self perception profile

    Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.

    Baseline

  • Self perception profile

    Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.

    After 4 weeks

  • Self perception profile

    Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.

    After 8 weeks

  • Self perception profile

    Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.

    After 12 weeks

  • Perth Emotional Reactivity Scale (PERS-S)

    The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.

    Baseline

  • Perth Emotional Reactivity Scale (PERS-S)

    The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.

    After 4 weeks

  • Perth Emotional Reactivity Scale (PERS-S)

    The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.

    After 8 weeks

  • Perth Emotional Reactivity Scale (PERS-S)

    The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.

    After 12 weeks

  • Modified Caregiver Strain Index (MCSI)

    The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.

    Baseline

  • Modified Caregiver Strain Index (MCSI)

    The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.

    After 4 weeks

  • Modified Caregiver Strain Index (MCSI)

    The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.

    After 8 weeks

  • Modified Caregiver Strain Index (MCSI)

    The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.

    After 12 weeks

  • Electromyography (EMG)

    EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.

    Baseline

  • Electromyography (EMG)

    EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.

    After 4 weeks

  • Electromyography (EMG)

    EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.

    After 8 weeks

  • Trunk control measurement scale (TCMS)

    Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.

    Baseline

  • Trunk control measurement scale (TCMS)

    Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.

    After 4 weeks

  • Trunk control measurement scale (TCMS)

    Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.

    After 8 weeks

  • Trunk control measurement scale (TCMS)

    Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.

    After 12 weeks

  • Pediatric Balance Scale (PBS)

    Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.

    Baseline

  • Pediatric Balance Scale (PBS)

    Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.

    After 4 weeks

  • Pediatric Balance Scale (PBS)

    Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.

    After 8 weeks

  • Pediatric Balance Scale (PBS)

    Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance, while score closer to zero indicate impaired balance.

    After 12 weeks

  • Dynamometer

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

    Bassline

  • Dynamometer

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

    After 4 weeks

  • Dynamometer

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

    After 8 weeks

  • Dynamometer

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

    After 12 weeks

  • Cerebral Palsy Quality of Life (CPQOL)

    Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain

    Baseline

  • Cerebral Palsy Quality of Life (CPQOL)

    Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain

    After 4 weeks

  • Cerebral Palsy Quality of Life (CPQOL)

    Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain

    After 8 weeks

  • Cerebral Palsy Quality of Life (CPQOL)

    Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain

    After 12 weeks

  • Edinburgh Visual Gait Assessment Score

    Edinburgh Visual Gait Assessment (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.

    Baseline

  • Edinburgh Visual Gait Assessment Score

    Edinburgh Visual Gait Assessment (EVGA ) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.

    After 4 weeks

  • Edinburgh Visual Gait Assessment Score

    Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.

    After 8 weeks

  • Edinburgh Visual Gait Assessment Score

    Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.

    After 12 weeks

  • Child friendly Depression Anxiety Stress Scale 21 (DASS-21)

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

    Baseline

  • Child friendly Depression Anxiety Stress Scale 21 (DASS-21)

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

    After 4 weeks

  • Child friendly Depression Anxiety Stress Scale 21 (DASS-21)

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

    After 8 weeks

  • Child friendly Depression Anxiety Stress Scale 21 (DASS-21)

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

    After 12 weeks

  • Immune Response Questionnaire (IRQ)

    The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status

    Baseline

  • Immune Response Questionnaire (IRQ)

    The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status

    After 4 weeks

  • Immune Response Questionnaire (IRQ)

    The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status

    After 8 weeks

  • Immune Response Questionnaire (IRQ)

    The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status

    After 12 weeks

  • Reaction Time

    Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time

    Baseline

  • Reaction Time

    Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time

    After 4 weeks

  • Reaction Time

    Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time

    After 8 weeks

  • Reaction Time

    Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time

    After 12 weeks

  • Heart rate variability (HRV)

    Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention.

    Baseline

  • Heart rate variability (HRV)

    Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention

    After 4 weeks

  • Heart rate variability (HRV)

    Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention

    After 8 weeks

  • Heart rate variability (HRV)

    Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention

    After 12 weeks

  • Manual Muscle Testing (MMT)

    Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.

    Baseline

  • Manual Muscle Testing (MMT)

    Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.

    After 4 weeks

  • Manual Muscle Testing (MMT)

    Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.

    After 8 weeks

  • Manual Muscle Testing (MMT)

    Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.

    After 12 weeks

  • Semi structured interview

    A semi-structured interview will be conducted with parents/ caregivers of CP subjects focusing on the feedback about treatment protocols and social, psychological and physical status and needs, and any observed change in needs or status

    After 8 weeks

Study Arms (3)

Focal muscle vibration group 1

EXPERIMENTAL

Focal muscle vibration with frequency of 80 Hz will be provided 3 days along with stretching, strengthening and positioning for 8 weeks

Device: Focal muscle vibrationProcedure: StretchingProcedure: StrengtheningProcedure: Positioning

Focal muscle vibration group 2

EXPERIMENTAL

Focal muscle vibration with frequency of 100 Hz will be provided 3 days a week along with stretching, strengthening and positioning for 8 weeks.

Device: Focal muscle vibrationProcedure: StretchingProcedure: StrengtheningProcedure: Positioning

Control group

ACTIVE COMPARATOR

Stretching, strengthening and positioning in 3 sessions a week for 8 weeks

Procedure: StretchingProcedure: StrengtheningProcedure: Positioning

Interventions

Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.

Focal muscle vibration group 1Focal muscle vibration group 2
StretchingPROCEDURE

Stretching of shortened lower extremity muscle

Control groupFocal muscle vibration group 1Focal muscle vibration group 2
StrengtheningPROCEDURE

Strengthening exercises for weak lower extremity muscles

Control groupFocal muscle vibration group 1Focal muscle vibration group 2
PositioningPROCEDURE

Positioning of participant to maintain a good body posture

Control groupFocal muscle vibration group 1Focal muscle vibration group 2

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed spastic diplegic cerebral palsy cases with following characteristics;
  • Gross motor function classification scale levels II-IV
  • Receiving standard physical therapy care

You may not qualify if:

  • Severe cognitive, visual and hearing impairments.
  • History of metabolic diseases.
  • History of recent fractures.
  • Children with severe musculo-skeletal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Farabi Special Education Center For (P.H.C)

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Resistance TrainingPatient Positioning

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Kiran Khushnood, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 parallel group mixed methods
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

March 3, 2023

Primary Completion

September 30, 2023

Study Completion

November 30, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations