| CTRI Number |
CTRI/2025/05/087612 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study investigates two exercise approaches to improve sitting balance after Stroke:A Study of Different Balance Training Methods |
|
Scientific Title of Study
|
Effectiveness of proactive and reactive strategies for improving sitting balance in 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 |
Dr Arya Pathak |
| Designation |
PG Student |
| Affiliation |
MGM School Of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of physiotherapy Gate No. 3, N6 cidco , Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9766426394 |
| Fax |
|
| Email |
aryapathak001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sant |
| Designation |
Associate Professor |
| Affiliation |
MGM School Of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of physiotherapy Gate No. 3, N6 cidco , Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8087671018 |
| Fax |
|
| Email |
namratasant08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya Pathak |
| Designation |
PG Student |
| Affiliation |
MGM School Of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of physiotherapy Gate No. 3, N6 cidco , Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9766426394 |
| Fax |
|
| Email |
aryapathak001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of neurophysiotherapy no. 5, MGM School of Physiotherapy, N6 Cidco, Aurangabad, 431001, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
Department of neuro physiotherapy no. 5 MGM School of Physiotherapy,N6 Cidco Aurangabad 431001, maharashtra, India |
| Type of Sponsor |
Private 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 Arya Pathak |
MGM School of Physiotherapy |
Neuro
OPD room number 5
MGM School of
physiotherapy, C
building N6 Cidco
Chhatrapati
Sambhajinagar
Maharashtra 431001,
India
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
09766426394
aryapathak001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics committee for Research on human subjects |
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 |
Proactive balance strategies along with conventional physiotherapy exercises |
Conventional physiotherapy exercises include stretching of tight muscles 10 repetitions × 1 set, strengthening 10 repetitions × 1 set, breathing exercises, 10 repetitions × 1 set, range of motion exercises, and 10 repetitions × 1 set, quadripud position.
Proactive balance strategies include pelvic bridging, sitting up, trunk flexion and extension, trunk lateral flexion, trunk rotation, and reaching.
|
| Comparator Agent |
Reactive balance strategies along with conventional physiotherapy exercises. |
Conventional physiotherapy exercises include stretching of tight muscles 10 repetitions × 1 set, strengthening 10 repetitions × 1 set, breathing exercises, range of motion exercises, and 10 repetitions × 1 set, the quadruped position. Reactive balance strategies include catching and throwing, perturbations in sitting and standing, dynamic weight shifts on a tilt board, dynamic weight shifts on a Swiss ball, verbal cues on a stable surface, and verbal cues on an unstable surface.
Each group will participate in 45-minute sessions twice a week for six weeks.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Survivors of subacute stroke
MOCA score of 26 or higher
Sitting unsupported for up to thirty seconds
Standing unsupported for up to thirty seconds
Willing to participate
|
|
| ExclusionCriteria |
| Details |
Auditory and Visual impairment
Sensory Aphasia
Recent injuries such as fractures and open wounds
Hemodynamically unstable
Repeated episodes of Stroke
subjects with earlier history of stroke in order to avoid already established habitual patterns of weight distribution in quiet sitting
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Trunk Impairment Scale (TIS)
|
Pre and Post Proactive and Reactive interventions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Postural Assessment Scale for Stroke patients (PASS) |
Pre- and Post Proactive and Reactive interventions |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 4 |
|
Date of First Enrollment (India)
|
03/06/2025 |
| 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 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
|
The aim of this study is to evaluate and compare the effectiveness of proactive and reactive balance training strategies in improving sitting balance and postural control among stroke patients. The objectives of this study are to find out the effectiveness of proactive and reactive strategies on pre- and post-scores of the Trunk Impairment Scale (TIS) and the Postural Assessment Scale for Stroke (PASS) in groups A and B. Also, to compare the post scores of the Trunk Impairment Scale (TIS) and the Postural Assessment Scale for Stroke (PASS) in groups A and B. |