| CTRI Number |
CTRI/2025/04/084466 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Benefits of Inclined Treadmill Walking on Hip Knee Ankle Angulation in Hemiparetic Patients |
|
Scientific Title of Study
|
Effect of inclined treadmill walking at multiple angle of inclination on hip knee ankle interaction among hemiparetic population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navin Vaidu |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy ,Nagpur |
| Address |
Department of Neurosciences Physiotherapy,Datta Meghe College of Physiotherapy,Shri Datta Meghe Polytechnic Campus,Wanadongri ,Hingna Road,Nagpur
441110
MAHARASHTRA
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9702198275 |
| Fax |
|
| Email |
nvaidu232@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Chaudhary |
| Designation |
Professor |
| Affiliation |
Datta Meghe College of Physiotherapy,Nagpur |
| Address |
Department of Neurosciences Physiotherapy,Datta Meghe College of Physiotherapy,Shri Datta Meghe Polytechnic Campus,Wanadongri ,Hingna Road,Nagpur
441110
MAHARASHTRA
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9975457653 |
| Fax |
|
| Email |
nehaneuro85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navin Vaidu |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy,Nagpur |
| Address |
Department of Neurosciences Physiotherapy,Datta Meghe College of Physiotherapy,Shri Datta Meghe Polytechnic Campus,Wanadongri ,Hingna Road,Nagpur
441110
MAHARASHTRA
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9702198275 |
| Fax |
|
| Email |
nvaidu232@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy,Nagpur |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Wanadongri,Hingna Road,Nagpur 441110,Maharashtra ,India |
| 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 |
| Navin Shyam Vaidu |
Datta Meghe College of Physiotherapy |
Neurosciences OPD, Datta Meghe College of Physiotherapy Wanadongri, Hingna road, Nagpur 441110, Maharashtra, India
Nagpur
MAHARASHTRA |
9702198275
nvaidu232@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing(APN) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inclined Treadmill Walking at Multiple Angle of Inclination |
Initially day 1 of week 1 the protocol starts at 0 degree of inclination and a constant speed which was calculated using the 10 m walk test. The speed will be constant and the angle of inclination will change after 5 days of protocol per week for a total duration of 4 week.
Time for inclined treadmill walking is 15min/day for 5 days/week for 4weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Able to Walk 10 meters Independently without an orthosis or a brace (FAS)
2. Berg Balance score Between 41-56
3. Modified Ashworth Scale Grade of LL Between 0 to 1+.
4. Subacute to chronic (greater than 6 months) stroke patients.
5. Positive Walkie talkie test |
|
| ExclusionCriteria |
| Details |
1. Presence of any visual auditory tactile impairments.
2. Presence of any Cognitive or perceptual disorder.
3. Presence or any history of neurological, musculoskeletal, or cardiovascular conditions.
4. Exhibiting pain or extreme discomfort that makes it difficult to carry out the suggested tasks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hip knee ankle interaction angulations using Kinovea Software |
Pre Intervention
Week 1
Week 2
Week 3
Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Pre Intervention
Week 1
Week 2
Week 3
Week 4 |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
18/04/2025 |
| 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
|
Stroke is a major global health issue and a
leading cause of death and disability worldwide. While it significantly impacts
high-income countries, its burden is growing rapidly in low- and middle-income
countries (LMICs), where 70% of all strokes occur, and the associated health
challenges are more severe.Hemiparetic gait post-stroke impairs mobility, balance, and daily activities. Inclined treadmill walking training (ITWMAI) may enhance joint angles, reduce abnormal forces, and improve gait efficiency. Understanding incline effects on paretic and non-paretic limbs can optimize rehabilitation, promote motor relearning, and enhance stroke survivors’ functional independence and overall quality of life This Single-Arm Study aims to evaluate the effect of inclined treadmill walking at multiple angles in hemiparetic population. Procedure- The Institutional Ethics Committee will grant ethical clearance. The selection of participants will be based on inclusion and exclusion standards. The participant will receive an explanation of the study’s purpose, goals, and methodology. On the consent form, consent will be obtained. Those who meet the requirements for selection will be invited to participate in the research. Participant will be asked for the drug history.Vitals will be examined before the Intervention starts. The necessary data will be taken from participants on a data collection sheet and pre-intervention Range of motion of Hip knee and ankle will be noted. Introduce and familiarize participants with the Treadmill. The intervention for ITWMAI will be given to the participants for 15 minutes/day for 5 days/week for a total duration of 4/week. Assessment of the angulations will be done on first minute of day one for the week and last minute of the fifth day for the week and continued for the next 4 weeks. Data will be analyzed. |