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CTRI Number  CTRI/2025/07/091139 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Helping Children with Spastic Cerebral Palsy Improve Balance Using Water and Land Therapies" 
Scientific Title of Study   Effect of Aquatic and Land Based Therapy on Postural Control in Spastic Cerebral Palsy An RCT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANKHI KHANAM 
Designation  Post Graduate Student 
Affiliation  Jessore University of Science & Technology 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  01611151266  
Fax    
Email  ankhi.khanam98pt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ehsanur Rahman  
Designation  Assistance Professor & Chairman 
Affiliation  Jashore University of Science and Technology 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  01716062263  
Fax    
Email  e.rahman@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  ANKHI KHANAM 
Designation  Post Graduate Student 
Affiliation  Jessore University of Science & Technology 
Address  Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Jashore University of Science and Technology


N/A
7408
Other 
Phone  01611151266  
Fax    
Email  ankhi.khanam98pt@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Jashore University of Science and Technology, Jashore – 7408, Bangladesh 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman 
Address  Room No. 401, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Jashore University of Science and Technology,Jashore – 7408, Bangladesh 
Type of Sponsor  Other [Academic Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumaya Sultana  PROYASH Institute of Special Education  Room No. 105, Department of Physiotherapy, PROYASH Institute of Special Education, Jashore Cantonment, Jashore – 7400, Bangladesh

 		 8801684416478

sumaiyasultana404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy and Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F82||Specific developmental disorder ofmotor function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aquatic Therapy  Total Duration: 12 weeks Frequency: 2 sessions per week Session Duration: 45 minutes per session Description- Warm-up: Walking in water (forward, sideways, and backward) Tone Control: Passive postures (e.g., child curled sideways in a ball) Stretching Exercises: Achilles tendon, hamstrings, hip flexors/adductors, shoulder internal rotation, elbow/wrist flexors/pronators (on poolside plinth) Righting & Equilibrium Training: Stride sitting in therapist’s lap; supine floating Balance Facilitation: Independent sitting, standing, weight shift, leg balance with support, balance board Gait Training: Walking in different directions in water. 
Comparator Agent  Land-Based Therapy  Total Duration: 12 weeks Frequency: 2 sessions per week Session Duration: 45 minutes per session Description: Tone Inhibition & Reflex Control: Reflex-inhibiting postures using proximal/distal key points (NDT principles) Trunk Control: Active trunk extension for postural balance Balance Training: From quadruped, kneeling, half-kneeling, and standing on mat or tilt board Righting & Equilibrium Reactions: Exercises on therapy ball and balance board Protective Reactions: Stimulus-induced stepping reactions (e.g., gentle pushes) Proprioceptive Training: Rhythmic joint approximation for ULs, LLs, and trunk Fine Motor Control: Reaching, grasping, and releasing tasks based on ability Stretching Exercises: For tight muscle groups (ULs, LLs) Gait Training: As appropriate  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Participants included in the study were those diagnosed with spastic cerebral palsy, classified within GMFCS levels I to III, able to follow simple instructions, and medically stable to undergo therapy. 
 
ExclusionCriteria 
Details  Participants with non-spastic types of cerebral palsy, GMFCS levels IV and V, severe cognitive impairments, uncontrolled seizure disorders, or those who have undergone recent orthopedic surgery or received botulinum toxin injections within the last six months were excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postural control measured using the Korean-Modified Trunk Control Measurement Scale (K-TCMS)  At baseline, 6 weeks, and 12 weeks after the start of intervention

 
 
Secondary Outcome  
Outcome  TimePoints 
Functional mobility & coordination measured using the Pediatric Evaluation of Disability Inventory (PEDI Scale)  At baseline, 6 weeks, & 12 weeks after the start of intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [e.rahman@just.edu.bd].

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is a randomised clinical trial designed to evaluate and compare the effectiveness of aquatic therapy and land-based therapy. Participants aged between 5-12 years diagnosed with spastic cerebral palsy. Children will be divided into two groups. one group will do exercise in water while another group will do the same exercise on land. The goal is to see which type of therapy helps to improve sitting, standing and balance better. Both group will receive structured therapy session, two session per week for 12 weeks. The primary outcome will be improvement postural control, assessed by Korean Trunk Control Measurement Scale (K-TCMS). The secondary outcome will include measure functional ability and quality of life, assessed by Pediatric Evaluation of Disability Inventory  (PEDI) and a structured observational checklist. This research hopes to find a better way to help children with spastic cerebral palsy.
 
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