Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
1 other identifier
interventional
111
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedStudy Start
First participant enrolled
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedJanuary 30, 2024
January 1, 2024
7 months
February 20, 2023
January 28, 2024
Conditions
Keywords
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
EXPERIMENTALFocal muscle vibration with frequency of 80 Hz will be provided 3 days along with stretching, strengthening and positioning for 8 weeks
Focal muscle vibration group 2
EXPERIMENTALFocal muscle vibration with frequency of 100 Hz will be provided 3 days a week along with stretching, strengthening and positioning for 8 weeks.
Control group
ACTIVE COMPARATORStretching, strengthening and positioning in 3 sessions a week for 8 weeks
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.
Stretching of shortened lower extremity muscle
Strengthening exercises for weak lower extremity muscles
Positioning of participant to maintain a good body posture
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Imran Amjad, PhD
Riphah International University
- PRINCIPAL INVESTIGATOR
Kiran Khushnood, MSNMPT
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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