- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07921186
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic Cerebral Palsy
To compare the effectiveness of core stability training and vestibular stimulation on sitting balance in hypotonic Cerebral Palsy
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qamar Mehmood
- Phone Number: 03335151063
- Email: qamar.mehmood@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Chakwal, Punjab Province, Pakistan
- Recruiting
- Helping Hand for Relief and Development
-
Contact:
- Qamar Mehmood
- Phone Number: 03335151063
- Email: qamar.mehmood@riphah.edu.pk
-
Principal Investigator:
- Zahra Jahan, MS-PPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Age between 2-8 years.
- Clinical diagnosis of hypotonic cerebral palsy.
- Segmental assessment of trunk control - not full independent trunk control.
- Cognitive ability (who follows command)
- Medical stability
Exclusion Criteria:
Progressive neurological disorder.
- Uncontrolled epilepsy.
- Visual or hearing impairment
- Behavioral problems
- Vertigo
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core stability and conventional
Core stability training and conventional therapy on sitting balance in Hypotonic cerebral palsy |
Basic core stability training with supine bridging, lateral weight shifting and conventional therapy with trunk facilitation. Sessions will be conducted 5 time per week for 8 weeks. Sessions lasts for 30 minutes. |
|
Active Comparator: Vestibular stimulation and conventional therapy
Vestibular stimulation and conventional therapy on sitting balance in hypotonic cerebral palsy |
Vestibular stimulation with gym ball and swing along with conventional therapy. Sessions will be conducted 5 time per week for 8 weeks. Sessions lasts for 30 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Segmental assessment of trunk control
Time Frame: week 0 , week 4, week 8
|
To evaluate trunk stability and it has 7 levels. Each level consists of 3 components(static, active and reactive). Trunk stability will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Balance Scale
Time Frame: week 0 , week 4, week 8
|
To assess static and dynamic balance. It consists of 14 items scoring from (0=unable, 1=maximal assistance , 2= moderate assistance , 3=minimal assistance). Total score is 56.Static and dynamic balance will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
|
Pediatric Evaluation of Disability inventory
Time Frame: week 0 , week 4, week 8
|
To assess functional mobility and daily activities. it consists of 3 domains scoring from (0= child does not perform activity , 1 = child perform activity). Total functional score is 12. Functional mobility will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
|
Reaching Performance Scale
Time Frame: week 0 , week 4, week 8
|
To assess quality of reaching movements. It has 6 components scoring from(0=no performance , 1= poor performance, 2= moderate performance, 3= good performance) Total score is 18.Quality of reaching movement will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Qamar Mehmood, MS, Riphah International University
Publications and helpful links
General Publications
- Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
- Elshafey MA, Abdrabo MS, Elnaggar RK. Effects of a core stability exercise program on balance and coordination in children with cerebellar ataxic cerebral palsy. J Musculoskelet Neuronal Interact. 2022 Jun 1;22(2):172-178.
- Khan MZ, Khaliq S, Asim M, Mahmood NQK, Khan FA, Khan FA, et al. Impact of Vestibular Stimulation on Motor Function and Balance in Children with Hypotonic Cerebral Palsy: A Randomized Controlled Trial. Multidisciplinary Surgical Research Annals. 2025;3(2):1-7.
- Sivaramachandran R, Natarajan M. Impact of sensory perceptual motor core stability training on sitting control in children with cerebral palsy. Fisioterapia em Movimento. 2025;38:e38118.
- Parashar A, Pattnaik M, Mohanty P. Effect of vestibular stimulation versus whole body vibration on standing balance in children with spastic diplegic cerebral palsy. J Nov Physiother. 2017;7(348):2.
- Rani M, Waqas S, Asim HM, Tariq M, Javaid A. Effectiveness of Vestibular Stimulation on Balance Using Swing Therapy in Children with Hypotonic Cerebral Palsy. Annals of King Edward Medical University. 2022;28(1).
- Yılmaz DA, Yildiz M, Yildirim MS, Ozlenir M. The The effects of core stability exercises on proprioception and balance in children with hemiplegic cerebral palsy. Retos. 2023;50:1123-8
- Elbasan B, Akaya KU, Akyuz M, Oskay D. Effects of neuromuscular electrical stimulation and Kinesio Taping applications in children with cerebral palsy on postural control and sitting balance. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):49-55. doi: 10.3233/BMR-169656.
- Mohamed N, Ibrahim MB, El-Agamy OA, Aldhahi MI, Elsebahy SY. Effects of Core Stability Training on Balance, Standing, and Gait in Children with Mild Cerebral Palsy: A Randomized Controlled Trial. Healthcare (Basel). 2025 May 29;13(11):1296. doi: 10.3390/healthcare13111296.
- Aravamuthan BR, Fehlings D, Shetty S, Fahey M, Gilbert L, Tilton A, Kruer MC. Variability in Cerebral Palsy Diagnosis. Pediatrics. 2021 Feb;147(2):e2020010066. doi: 10.1542/peds.2020-010066. Epub 2021 Jan 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/MS-PT/02473 Zahra Jahan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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