| CTRI Number |
CTRI/2026/01/101179 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Walking Training Methods to Improve Knee Control in People with Long-Term Stroke |
|
Scientific Title of Study
|
Efficacy of Treadmill Training with Partial Body Weight Support vs. Overground Gait Training on Knee Hyperextension in Chronic 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 |
D Vignesh Prabhu |
| Designation |
Head of the department |
| Affiliation |
The Tamil Nadu Dr. M.G.R. Medical University |
| Address |
Thirumalayampalayam
Nehru Gardens
Coimbatore
No. 69, Anna Salai, Guindy,
Chennai - 600 032,
Tamil Nadu
India.
Chennai
TAMIL NADU
641105
India |
| Phone |
919677649999 |
| Fax |
|
| Email |
vijayarajmpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D Vignesh Prabhu |
| Designation |
Head of the department |
| Affiliation |
The Tamil Nadu Dr. M.G.R. Medical University |
| Address |
Thirumalayampalayam
Nehru Gardens
Coimbatore
No. 69, Anna Salai, Guindy,
Chennai - 600 032,
Tamil Nadu
India.
Chennai
TAMIL NADU
641105
India |
| Phone |
919677649999 |
| Fax |
|
| Email |
vijayarajmpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D Vignesh Prabhu |
| Designation |
Head of the department |
| Affiliation |
The Tamil Nadu Dr. M.G.R. Medical University |
| Address |
Thirumalayampalayam
Nehru Gardens
Coimbatore
No. 69, Anna Salai, Guindy,
Chennai - 600 032,
Tamil Nadu
India.
Coimbatore
TAMIL NADU
641105
India |
| Phone |
919677649999 |
| Fax |
|
| Email |
vijayarajmpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Physiotherapy Hospita; and Research Center
Thirumalayampalayam
Coimbatore-641105 |
|
|
Primary Sponsor
|
| Name |
D Vignesh Prabhu |
| Address |
No 6 EB Colony
Kuniyamuthur
Coimbatore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nehru Physiotherapy Hospita and Research Center |
Thirumalayampalayam Coimbatore-641105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vignesh Prabhu |
Nehru Physiotherapy Hospital and Research Center |
Department of physiotherapy
Block I
Nehru Gardens
Thirumalayapalayam
Coimbatore
Coimbatore
TAMIL NADU |
9677649999
vijayarajmpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G935||Compression of brain, (2) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Body-Supported Treadmill Training |
Body-supported treadmill training will be receive once in a day for 5 days in a week for 6 weeks |
| Comparator Agent |
Overground Gait Training |
Overground Gait Training will be receive once in a day for 5 days in a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
First-ever unilateral stroke more than 6 months post-onset
Presence of knee hyperextension during gait
Ability to walk at least 10 meters with or without an assistive device
Brunnstrom stage more than third for the lower limb
MMSE score more than 24 |
|
| ExclusionCriteria |
| Details |
Subject with any additional history of neurological issues.
History of Voice Disorders
Severe Cognitive Impairment
Recent Surgery or Injury
Patients who have recently undergone any knee surgeries
People with serious psychiatric disorders (like schizophrenia or bipolar disorder) that could change their mood or voice will not be allowed to participate unless the disorder is well-controlled and stable.
Getting drunk on alcohol
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hyperextension
2. Gait speed |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. 10-meter walk test |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/01/2026 |
| 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="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
|
100 patients clinically diagnosed Post stroke will be selected for the study in that 10 patients were excluded and ninety patients were consecutively divided into two equal groups Totally Ninety clinically diagnosed Post Stroke patients will be selected for the study and consecutively divided in to two equal groups All two Groups patients will be involved for pretest assessment Experimental Group 1 will receive Partial body weight supported treadmill training Experimental Group 2 will receive over ground gait training All two groups will receive their treatment once in a day for 5 days in a week for 6 weeks Knee hyperextension during stance phase measured using observational gait analysis and goniometry Gait speed ,step length and Functional were measured by 10-meter walk test. A post test assessment was done at the end of the 6 weeks After the post test assessment the subjects belonging to both the groups performed Conventional Physiotherapy for 2 months to understand the maintenance effect of the improvement gained in the groups After 6 weeks of treatment the pre and post results of the scales were administered and the results will be calculated to know the effect of two Groups on SPSS software. |