| 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
|
|
|
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
|
|
|
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. |