NCT04894799

Brief Summary

there is no such article found who specifies the effects of sensory integration therapies like vestibular stimulation technique or developmental milestone while controlling the gender of children with cerebral palsy. So, there is a need to do more research work on this in future to find out best treatment approach for children with cerebral palsy of their respective gender. That is why this study will focus on the results of vestibular stimulation and neurodevelopmental technique while controlling the Gender distribution of both intervention groups to find out the effects of these interventions that wither, they have some influence on the participants or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

May 19, 2021

Last Update Submit

February 20, 2022

Conditions

Cerebral PalsyHypotonia

Keywords

developmental milestoneshypotoniavestibular stimulation

Outcome Measures

Primary Outcomes (2)

  • Infant Neurological International Battery

    Infant Neurological International Battery ( INFANIB) is the developmental screening tool used for the assessment of neuromotor development in neonates and infants aged 1-18 months. The score of each item is mentioned in the score sheet itself based upon age and calculating total score will determine the neuromotor state of infants.

    10 weeks

  • GMFM-88

    It is a Standardized Observational Instrument designed and validated to measure change in gross motor function over time in children with Cerebral Palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest, selected goal areas and a total GMFM-88 score.

    10 weeks

Study Arms (2)

Vestibular stimulation

EXPERIMENTAL

all participants will be given Infant Swing activity for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Infant Swing for 30 minutes and frog swing for 30 minutes for two weeks. Next 7th and 8th weeks, Infant Swing (30 minutes) and prone on frog swing feet touching the floor (30 minutes), trice a day will be applied. In 9th week, Infant swing and normal playground swing for 30,30 minutes will be given to all participants, trice a day. In Last week of intervention i.e., 10th week, all participants will be given Infant Swing for 30 minutes and standing on platform swing (30 minutes) trice a day.

Other: Vestibular stimulation

Neck Control facilitation exercises

ACTIVE COMPARATOR

all participants will be given Neck Control facilitation exercises using Bobath Approach of low tone facilitation method, for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Neck Control facilitation exercises for 30 minutes and sitting facilitation Exercises with trunk weight shifting for 30 minutes, trice a day. Next 7th and 8th weeks, Neck Control facilitation exercises (30 minutes) and sitting facilitation exercises with trunk weight shifting and kneeling weight bearing (30 minutes), trice a day will be applied. In 9th and 10th weeks, Neck Control facilitation exercises, sitting and kneeling weight bearing and standing with trunk elongation will be given to all participants for one hour, trice a day.

Other: Neck Control facilitation exercises

Interventions

Vestibular stimulationOTHER

In Vestibular Stimulation (VS) group, all participants will be given Infant Swing activity for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Infant Swing for 30 minutes and frog swing for 30 minutes for two weeks. Next 7th and 8th weeks, Infant Swing (30 minutes) and prone on frog swing feet touching the floor (30 minutes), trice a day will be applied. In 9th week, Infant swing and normal playground swing for 30,30 minutes will be given to all participants, trice a day. In Last week of intervention i.e., 10th week, all participants will be given Infant Swing for 30 minutes and standing on platform swing (30 minutes) trice a day.

Vestibular stimulation
Neck Control facilitation exercisesOTHER

all participants will be given Neck Control facilitation exercises using Bobath Approach of low tone facilitation method, for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Neck Control facilitation exercises for 30 minutes and sitting facilitation Exercises with trunk weight shifting for 30 minutes, trice a day. Next 7th and 8th weeks, Neck Control facilitation exercises (30 minutes) and sitting facilitation exercises with trunk weight shifting and kneeling weight bearing (30 minutes), trice a day will be applied. In 9th and 10th weeks, Neck Control facilitation exercises, sitting and kneeling weight bearing and standing with trunk elongation will be given to all participants for one hour, trice a day.

Neck Control facilitation exercises

Eligibility Criteria

Age6 Months - 4 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf representation of gender identity
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hypotonic CP
  • GMFM-88 ranges: With true score of zero (0) = does not initiates i.e., head control absent at age of 6 months
  • Tone: 6 months infants total scoring ≤ 54 and 8 month or more total scoring ≤ 68 on Infant Neurological international Battery Scoring Sheet will be included.

You may not qualify if:

  • Children with other Abnormalities and pathologies like Down syndrome, Joubert Syndrome
  • Children Undergone any kind of surgery like reconstruction surgeries for congenital defects of eyes, head, neck or all four limbs of the body
  • Children with other type of Cerebral Palsy (CP) like Spastic (Hypertonic), Choreoathetoid, Dystonic, Ataxia, Athetoid and mixed CP
  • Children with any other neurological deficits, Mentally Challenged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand Comprehensive Rehabilitation Center

Chakwal, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Hypotonia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mirza Obaid Baig

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 20, 2021

Study Start

May 30, 2021

Primary Completion

December 30, 2021

Study Completion

January 31, 2022

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)