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CTRI Number  CTRI/2026/02/104678 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Aquatic Therapy on lower limb strength and motor function in children with Spastic Diplegic Cerebral Palsy 
Scientific Title of Study   Effect of Strength Training Aquatic Therapy (STAT) protocol on lower limb strength and motor function in children with Spastic Diplegic Cerebral Palsy - A pre-post pilot study 
Trial Acronym  STAT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepa Metgud 
Designation  Physiotherapist 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy centre department of pediatric physiotherapy room no.39 sagar floor Belgaum Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9845861236  
Fax    
Email  drdeepa_metgud@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Janhvi Dhote 
Designation  Physiotherapist 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy centre department of pediatric physiotherapy room no.39 sagar floor Belgaum Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8484978737  
Fax    
Email  janhviskee21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Janhvi Dhote 
Designation  Physiotherapist 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy centre department of pediatric physiotherapy room no.39 sagar floor Belgaum Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8484978737  
Fax    
Email  janhviskee21@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi 590010, Karnataka, India 
 
Primary Sponsor  
Name  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi-590010 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepa Metgud  KAHER Institute of Physiotherapy  Advanced Physiotherapy centre department of pediatric physiotherapy room no.39 sagar floor Belgaum Karnataka
Belgaum
KARNATAKA 
9845861236

drdeepa_metgud@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER INSTITUTE OF PHYSIOTHERAPY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  STAT Protocol  Intervention The intervention consists of the Strength Training Aquatic Therapy protocol administered in a temperature controlled pool maintained at 33 to 35 degrees Celsius. The program is designed to provide progressive lower limb strengthening in children with spastic diplegic cerebral palsy by utilizing the properties of water such as buoyancy hydrostatic pressure viscosity and thermal effects. The intervention will be delivered by a qualified physiotherapist three times per week for six weeks. Each session will last 45 to 60 minutes and attendance will be monitored. Each session will include four phases. Warm up for 10 minutes will include forward walking and cycling movements in water to activate muscles and prepare the lower limbs. Phase one for 15 to 20 minutes will focus on isolated strengthening exercises such as leg lifts knee extensions ankle dorsiflexion leg abduction and rotational control performed against water resistance. Phase two for 15 to 20 minutes will include functional strengthening activities such as power walking jumping single leg standing step up and step down and resisted leg abduction. Exercises will be progressed gradually based on tolerance. Cool down for 5 to 10 minutes will include hamstring and quadriceps stretching and slow walking to promote relaxation. Total duration will be 2 to 3 sessions per week for 6 weeks. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children whose parents/guardians give consent to participate in the study
Children of both genders aged between 5–14 years diagnosed with spastic diplegic cerebral palsy
Children classified as GMFCS level I, II, III
Able to follow simple commands (with or without caregiver assistance) 
 
ExclusionCriteria 
Details  History of any recent surgery or botulinum toxin injections (within the past 6 months)
Children with conditions like uncontrolled epilepsy, severe cardiopulmonary disease, skin infections, open wounds, non-healed surgical incisions, hydrophobia
Children diagnosed with severe cognitive impairment
Children participating in another physical therapy intervention targeting lower limb strengthening during the study period 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Push-pull Hand-held Dynamometry, Gross Motor Function Measure-66  T0- Baseline, T1- At the end of week 3, T3- At the end of week 6 
 
Secondary Outcome  
Outcome  TimePoints 
Selective Motor Control Assessment of Lower Extremity (SCALE), Modified Ashworth Scale (MAS), Goniometry  T0- Baseline, T1- At the end of week 3, T3- At the end of week  
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
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)   02/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This study is a pre post pilot experimental study that aims to evaluate the effect of a Strength Training Aquatic Therapy protocol on lower limb muscle strength and motor function in children with spastic diplegic cerebral palsy. Cerebral palsy is a non progressive neurological disorder that affects movement and posture and spastic diplegia is the most common subtype predominantly involving the lower limbs. Aquatic therapy is considered beneficial in this population due to the buoyancy thermal and mechanical properties of water which help reduce spasticity joint loading and balance demands while facilitating movement and strengthening.

The study will be conducted over a period of six months and will include eleven children aged five to fourteen years diagnosed with spastic diplegic cerebral palsy classified under GMFCS levels one to three. Participants will be recruited from a tertiary care hospital and special schools in Belagavi. After obtaining ethical clearance informed parental consent and child assent baseline assessment will be done for lower limb muscle strength gross motor function selective motor control spasticity and range of motion.

The intervention consists of the STAT protocol administered three times a week for six weeks in a temperature controlled aquatic pool. Each session includes warm up progressive strengthening and functional exercises and cool down. Outcome measures include hand held dynamometry GMFM sixty six SCALE Modified Ashworth Scale and goniometry which will be assessed at baseline three weeks and six weeks.

Data will be analyzed using descriptive statistics and appropriate inferential tests to determine the effectiveness of the protocol. The study intends to provide preliminary evidence on whether a structured progressive aquatic strength training protocol can improve lower limb strength motor function selective motor control spasticity and range of motion in children with spastic diplegic cerebral palsy and help guide future larger trials.
 
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