| CTRI Number |
CTRI/2024/11/077294 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effect of treadmill training with metronome beats and conventional treatment on gait outcomes and Quality of Life in post stroke patients |
|
Scientific Title of Study
|
Comparison of treadmill training with Rhythmic auditory stimulation and conventional treatment on gait outcomes and Quality of life in post stroke patients: randomized control 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 |
Kanksha Desai |
| Designation |
Final year Student |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Neuro Physiotherapy Department
Gym Hall
Dr APJ Abdul Kalam College of Physiotherapy
Pravara institute of Medical sciences
Cardio Respiratory Department
Dr APJ Abdul Kalam College of Physiotherapy
Pravara institute of Medical sciences
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9920735477 |
| Fax |
|
| Email |
kankshadesai7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shyam kurupati |
| Designation |
HOD NeuroPhysiotherapy |
| Affiliation |
Dr APJ Abdul kalam college of Physiotherapy |
| Address |
Neuro Physiotherapy Department
Dr APJ Abdul Kalam College of Physiotherapy
Pravara institute of Medical sciences
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8978438484 |
| Fax |
|
| Email |
kurapatiphysiotherapy2023@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanksha Desai |
| Designation |
Student |
| Affiliation |
Dr APJ Abdul kalam college of Physiotherapy |
| Address |
Dr APJ Abdul kalam college of Physiotherapy
Pravara institute of Medical sciences
Loni 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9920735477 |
| Fax |
|
| Email |
kankshadesai7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr APJ Abdul kalam college of Physiotherapy, PIMS DU
Loni 413736 , Ahmednagar
Maharshtra
|
|
|
Primary Sponsor
|
| Name |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Dr APJ Abdul Kalam College of Physiotherapy
Pravara Institute of Medical Sciences
Loni 413736 , Ahmednagar
Maharashtra |
| Type of Sponsor |
Other [Pravara Medical college Deemed to be university] |
|
|
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 |
| Kanksha Desai |
Dr APJ Abdul kalam College of Physiotherapy |
Neurophysiotherapy Department
Dr APJ Abdul kalam College of Physiotherapy
Pravara Institute of Medical Sciences
Loni 413736,Ahmednagar
Maharashtra
Ahmadnagar
MAHARASHTRA |
9920735477
kankshadesai7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr APJ Abdul Kalam College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
For duration of 3 weeks
Strength training of lower limb with theraband (10 reps 2 sets), step training, symmetrical weight bearing , weight shifting between lower limbs (10 reps 2 sets), for period of 30 mins for period of 5 times/week to improve gait outcomes and quality of life in post stroke patients. |
| Intervention |
Treadmill training with Rhythmic Auditory Stimulation |
For duration of 3 weeks Rhythmic auditory stimulus using metronome beats along with treadmill training will be given to enhance gait training for duration of 30 mins for period of 5 times/week.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to participate.
2.Both males and female post stroke patients.
3.Age above 35 years.
4.Berg balance score more than 20.
5.Patients who have ability to understand and follow commands.
|
|
| ExclusionCriteria |
| Details |
1.Patients with significant hearing impairment such that they are unable to respond to verbal instructions or auditory stimuli.
2.Disoriented patients.
3.Patients with cardiopulmonary conditions.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Gait , Quality of life
Berg balance scale.
Dynamic gait index.
Stroke specific Quality of life scale.
|
Week 0 TO Week 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Balance , Strength |
Week 0 TO Week 3 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2024 |
| 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
|
Study design will be prepared prior to commencement of the study and ethical approval from IEC will be taken at Dr .APJ Abdul Kalam College of Physiotherapy. 1.1 Sent for Approval of randomized control trial. 2.Samples will be identified according to the inclusion exclusion criteria. 3.Demographic data will be taken including name, age, height etc. 4.Pre assessment will be done with the consent of the patient using berg balance scale and dynamic gait index . Quality of life pre treatment will be taken. 5.Two groups will be made. 6.One group rhythmic auditory stimulus using metronome beats along with treadmill training will be given to enhance gait training for duration of 30 mins for period of 5 times/week for 3 weeks. 7.Other group will be given conventional treatment for period of30 mins for period of 5 times/week for 3 weeks. 8.Quality of life and gait parameters will be re assessed in both the groups. 9.Comparision between both the findings will be done and conclusion will be made. |