| CTRI Number |
CTRI/2024/07/070427 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of telerehabilitation in stroke patients using various exercises |
|
Scientific Title of Study
|
To evaluate the effect of exercise based telerehabilitation in patients with acute stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Mittal |
| Designation |
PG Student |
| Affiliation |
Collage of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy department, College of Physiotherapy, E-block, PGIMS
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9812269486 |
| Fax |
|
| Email |
sahilshallu2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Verma |
| Designation |
Assistant Professor |
| Affiliation |
Collage of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy department, College of Physiotherapy, Faculty room, E-block, PGIMS
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9992822644 |
| Fax |
|
| Email |
bhawna_pt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna Verma |
| Designation |
Assistant Professor |
| Affiliation |
Collage of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy department, College of Physiotherapy, Faculty room, E-block, PGIMS
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9992822644 |
| Fax |
|
| Email |
bhawna_pt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Rohtak, Haryana, India
124001 |
| Type of Sponsor |
Government medical college |
|
|
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 Bhawna Verma |
Pt. B.D. Sharma PGIMS, Rohtak |
Neuro Rehabilitation Room
E-Block
College of Physiotherapy
Rohtak, Haryana, India
124001
Rohtak
HARYANA |
9992822644
bhawna_pt@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G825||Quadriplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise protocol will be divided in 8 sub categories:-
1. Bridging
2. Lifting toes and ankle
3. Sitting and Standing
4. Stretching out arms while standing
5. Step and stair exercises
6. Gait training and balance training
7. Range of motion Exercise
8. Activities of daily living |
The telerehabilitation sessions will be conducted on the 7th, 15th, 30th day of discharge in one month and than every once in a month foe next 2 months through the use of google meet. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with acute stroke who admitted in neurology department.
2. Age above 18 years will be included
3. Both Males and Females will be included
4. Patients with mRS score 1-4 will be included
5. Patients with NIHSS score 2-20 will be included |
|
| ExclusionCriteria |
| Details |
1. Subjects with Unconsciousness and Cognitive difficulty will be excluded
2. Patients with Cooperation difficulty will be excluded
3. Patients who lack internet and a smartphone will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Barthel Index, Stroke Rehabilitation Assessment of Movement, National Institutes of Health Stroke Scale |
At the time of discharge, After all 5 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin Scale, Berg Balance Scale |
At the time of discharge, After all 5 sessions |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| 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 Yet Recruiting |
| 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
|
Title: "To evaluate the effect of exercise based telerehabilitation in patients with acute stroke"
Method/Design: This study investigating the effect of 5 sessions of supervised exercise based telerehabilitation on 20 patients with acute stroke. The main inclusion criteria are patients with age above 18 years, both males and females will be included, patients mRS score will be 1-4 and NIHSS score will be 2-20 and patients with acute stroke who admitted in neurology department will be included. The primary outcome measures are: The Barthel Index, Stroke Rehabilitation Assessment of Movement, Modified Rankin Scale, and National Institutes of Health Stroke Scale. Participants will take part in 5 supervised exercise based telerehabilitation sessions post hospital discharge.
Discussion: This study will explore the effect of exercise based telerehabilitation in patients with acute stroke. The results will contribute to a better understanding of exercise based telerehabilitation that will improve the quality of rehabilitation. in acute stroke patients. The study results design a better rehabilitation program for patients with acute stroke. |