| CTRI Number |
CTRI/2026/02/104356 [Registered on: 19/02/2026] 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 Water-Based Therapy on Movement and Depression Recovery after Stroke |
|
Scientific Title of Study
|
Feasibility And Impact Of Water Specific Therapy (WST) Intervention On Lower Limb Motor Function And Depression In Subacute Stroke Patients: A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smruti Sayaji Mane |
| Designation |
PG Student |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9158124343 |
| Fax |
|
| Email |
Smrutimane2813@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smruti Sayaji Mane |
| Designation |
PG Student |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9158124343 |
| Fax |
|
| Email |
Smrutimane2813@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smruti Sayaji Mane |
| Designation |
PG Student |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9158124343 |
| Fax |
|
| Email |
Smrutimane2813@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar kore Hospital and Medical Research center, Nehru Nagar, Belagavi, Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
Smruti Sayaji Mane |
| Address |
KLE Institute Of Physiotherapy, Nehru Nagar, Belagavi, Karnataka- 590010 |
| Type of Sponsor |
Other [self ] |
|
|
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 Smruti Mane |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
KLEs Dr. Prabhakar
Kore Hospital and
Medical Research
Center, Room No. 39,
Sagar Floor, Advanced
Physiotherapy Centre,
Department of
Neurophysiotherapy,
Belgaum Karnataka.
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9158124343
Smrutimane2813@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Land based Exercises |
Intervention- 45mins of treatment time for 2 weeks duration-3 times per week |
| Intervention |
Water Specific Therapy Group |
Intervention- 45mins of treatment time for 2 weeks duration-3 times per week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Population Subacute Stroke Patients diagnosed for the first time in age group of
18 to 60 years of both genders.
Brunnstrom Stage of minimum 3.
Ability to follow instructions.
Ability to walk without any aid or need of continuous physical assistance to support
body weight or maintain balance (Functional Ambulation Classification more than equal to 3) |
|
| ExclusionCriteria |
| Details |
Associated pathologies or conditions that could compromise the performance of the
task like major diseases such as heart, liver, kidney dysfunction, poor glycemic
control of diabetes, infectious diseases, tracheostomy, bedsores, incontinence and
perforation of the tympanic membrane.
Cognitive impairment identified by Mini-Mental State Examination (MMSE) less than 24
Lack of ability to cooperate.
Rejection of aquatic therapy/hydrophobia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) And
The Patient Health Questionnaire-9 (PHQ-9) |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale (BBS), Wota Scale and The Rivermead Mobility Index |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
16/03/2026 |
| 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="1"
Months="0"
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
|
Feasibility And Impact Of Water Specific Therapy (WST) Intervention On Lower Limb Motor Function And Depression In Subacute Stroke Patients: A Randomized Controlled Trial
This study focuses on improving recovery in people with subacute stroke, where impaired lower limb motor function and depression can significantly limit mobility, independence, and quality of life. Although rehabilitation programs commonly use land-based exercises, hydrotherapy offers unique physical properties that may enhance motor control, balance, and gait more effectively. However, there is limited structured evidence on the feasibility and clinical impact of a standardized water-specific therapy protocol in subacute stroke patients. The aim of this study is to evaluate both the feasibility and effectiveness of Water-Specific Therapy (WST) on lower limb motor function and depression using outcome measures including the Berg Balance Scale, Fugl-Meyer Assessment (Lower Limb), Patient Health Questionnaire-9, Water Orientation Test Alyn (WOTA), and Rivermead ADL Scale. In this randomized controlled trial, subacute stroke participants will be assigned to intervention groups to receive WST-based rehabilitation, and assessments will be conducted before and after the intervention to compare functional and psychological outcomes. |