| CTRI Number |
CTRI/2024/09/074500 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to see effect of Lateral and Backward Treadmill walking on Balance and Walking speed in chronic stroke or paralysis patient |
|
Scientific Title of Study
|
Effect of 4-Week Lateral and Backward Treadmill walking training on Balance and Walking ability in individuals with Chronic Stroke – 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 |
Saiyed Muskanbegam Mohammad Rais |
| Designation |
PG student |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education Navsari |
| Address |
neuro out patient department ground floor s s agrawal institute of physiotherapy agrawal college campus verranjali marg 1 devina
park navsari
Navsari
GUJARAT
396445
India |
| Phone |
9662076586 |
| Fax |
|
| Email |
drmuskansaiyedpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagruti Patel |
| Designation |
Associate Professor PG guide Phd scholar |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
neuro out patient department ground floor s s agrawal institute of physiotherapy agrawal college campus verranjali marg 1 devina
park navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagruti Patel |
| Designation |
Associate Professor PG guide Phd scholar |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
neuro out patient department ground floor s s agrawal institute of physiotherapy agrawal college campus verranjali marg 1 devina
park navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S agrawal institute of physiotherapy and medical care education, navsari, gujarat. 396445
agrawal college campus, out patient department, verranjali 1 marg, devina park, navsari. |
|
|
Primary Sponsor
|
| Name |
Saiyed Muskanbegam Mohammad Rais |
| Address |
302-B, Gulistan Appt. Karimnagar, bhagdawada, Valsad-396001 |
| 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 Shlesha Vaidya |
s.s.agrawal institute of physiotherapy and medical care education, navsari |
department of
physiotherapy,ground
floor, agrawal college
campus, viranjali van
marg, devina park,
navsari
Navsari
GUJARAT
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee S S Agrawal Institute of Physiotherapy and Medical Care Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Backward Treadmill walking training |
Backward walking on treadmill for 30 minutes, 5 days/week for 4 weeks |
| Intervention |
Conventional Physiotherapy Protocol |
Stretching, Strengthening, Range of motion, Balance exercises |
| Intervention |
Lateral Treadmill walking training |
Lateral walking on treadmill for 30 minutes, 15 minutes each side, 5 days/week for 4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Onset of stroke at least 6 months prior to enrolment in the study.
Belonging to any gender from age 40 to 70 years.
Ability to walk at least 10 m with or without ankle-foot orthosis.
Brunnstrom’s lower limb recovery stage ≥ 3.
Those who understood verbal instructions and had a Mini-Mental State Exam score ≥ 24 were included. |
|
| ExclusionCriteria |
| Details |
Cognitive, Perceptual or Visual impairment.
Any orthopaedic condition involving lower limb.
Any neurological problem with movement disorder.
Another uncontrolled health condition for which exercise is contraindicated (uncontrolled hypertension or heart disease that necessitates a pacemaker, coronary heart disease, arrhythmia, rheumatic heart disease, heart failure or angina). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg balance scale, 10 meter walk test |
Berg balance scale, 10 meter walk test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2024 |
| 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 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
|
To evaluate the impact of backward treadmill walking training on balance and walking ability of people dealing with chronic stroke. To evaluate the impact of lateral treadmill walking training on balance and walking ability of individuals coping with chronic stroke. To compare how backward and lateral treadmill walking training influence balance and walking ability among those with chronic stroke. |