| CTRI Number |
CTRI/2025/03/082433 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving walking and upper body alignment in stroke patients using body alignment exercises and a Visual Gait Mat |
|
Scientific Title of Study
|
Effect of Trunk exercises augmented with visual gait
mat on trunk asymmetry and spatiotemporal parameters of gait in stroke
patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMI ROSE |
| Designation |
Research scholar |
| Affiliation |
Kempegowda Institute of Physiotherapy |
| Address |
Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore
Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
8880726780 |
| Fax |
|
| Email |
rosempt20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUMI ROSE |
| Designation |
Research scholar |
| Affiliation |
Kempegowda Institute of Physiotherapy |
| Address |
Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore
Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore 560004
KARNATAKA
560004
India |
| Phone |
8880726780 |
| Fax |
|
| Email |
rosempt20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUMI ROSE |
| Designation |
Research scholar |
| Affiliation |
Kempegowda Institute of Physiotherapy |
| Address |
Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore
Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore 560004
KARNATAKA
560004
India |
| Phone |
8880726780 |
| Fax |
|
| Email |
rosempt20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda Institute of Physiotherapy
Krishnarajendra Road
,Visveswarapuram,Bangalore 560004 |
|
|
Primary Sponsor
|
| Name |
Sumi Rose |
| Address |
Research Scholar
Kempegowda Institute of Physiotherapy
K.R. Road, V.V.Puram,
Bangalore – 560 004 |
| 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 |
| DrPrem Kumar B N |
Kempegowda Institute of Medical Sciences Hospital and Research centre |
Department of Physiotherapy
Ground Floor
Krishnarajendra Road
,Visveswarapuram,Bangalore 560004
Bangalore
KARNATAKA |
9845047646
premkumarbn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kempegowda Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional therapy |
DURATION OF THE STUDY : 6 Weeks including trunk strngthening exercise per subject for 2 years
conventional therapy based on the treatment protocol followed such as strengthening exercise gait training ,passive and active range of Motion. |
| Intervention |
Gait training |
DURATION OF THE STUDY : 2 Weeks per subject for 2 years
Implementation Strategy: The Principal investigators Neuro Physiotherapist will assess the outcome measures pre and post intervention and two physiotherapist will be giving the exercise protocol at the home of the patients and will be blinded about the pre and post assessment of the patients. |
| Comparator Agent |
Trunk strengthening exercise |
DURATION OF THE STUDY : 4 Weeks per subject for 2 years
Position Stable surface 1 to 4 weeks Sitting Trunk flexion and extension Trunk lateral flexion side to side Lower trunk flexion by initiating movement from pelvic girdle Upper trunk lateral flexion initiating movement from shoulder gridle Lateral trunk rotation Forward reach Unstable Surface 4th to 6th week Trunk flexion and extension Seated on physio ball Trunk lateral flexion side to side on physio ball Lower trunk flexion by initiating movement from pelvic girdle on physio ball Upper trunk lateral flexion initiating movement from shoulder gridle on physio ball Lateral trunk rotation on physio ball Forward reach on physio ball |
| Intervention |
Trunk strengthening exercise |
DURATION OF THE STUDY : 4 Weeks per subject for 2 years
Position
Stable surface 1 to 4 weeks
Sitting
Trunk flexion and extension
Trunk lateral flexion side to side
Lower trunk flexion by initiating movement from pelvic girdle
Upper trunk lateral flexion initiating movement from shoulder gridle
Lateral trunk rotation
Forward reach
Unstable Surface 4th to 6th week
Trunk flexion and extension Seated on physio ball
Trunk lateral flexion side to side on physio ball
Lower trunk flexion by initiating movement from pelvic girdle on physio ball
Upper trunk lateral flexion initiating movement from shoulder gridle on physio ball
Lateral trunk rotation on physio ball
Forward reach on physio ball
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with stroke by the Neurologist
Scoring not less than 18 on MOCA scale
Brunnstrom stage 4
Community- ambulating post stroke subjects |
|
| ExclusionCriteria |
| Details |
Perceptual and cognitive deficit patients.
Patients with visual disorder
Other neurological disorders such as Parkinson’s disease, recurrent and bilateral stroke,
nerve injuries, vestibular disorders
Cardiac dysfunction.
Cardiopulmonary diseases
Unable to perform the exercises.
History of Orthopaedic and degenerative disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk impairment scale: |
At Baseline, 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional gait analysis |
Base line & at sixth week |
| Distance parameters of gait |
Baseline & at sixth week |
| Scoliometer smartphone app: |
Base line & at 6th week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/03/2025 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - DRIVE
- For how long will this data be available start date provided 12-12-2025 and end date provided 12-12-2026?
Response (Others) - DURING THE STUDY
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
Title
of the Research topic
|
Effect of Trunk exercises augmented with visual gait mat on trunk asymmetry and spatiotemporal parameters of
gait in stroke patients.
|
|
Brief
resume of the intended Research work
|
Background : Trunk Impairment occurs as a result of
trunk muscle weakness. Stroke is a leading cause of adult disability, and
postural deviations are common among stroke patients. Weakness on the
hemiplegic side can compromise the symmetry of the trunk musculature and can
lead to the development of progressive deviation and alteration in spatiotemporal
parameters of gait.
Novelty:
The role of trunk function in predicting functional outcome after stroke has
been recognized as significant. Trunk muscles play a crucial role in
maintaining upright posture, weight shifts, and movement control against the
constant pull of gravity. Weakness in these muscles has a considerable impact
on gait and balance. The proposed study introduces a novel concept:
addressing Trunk deviation in Stroke individuals through physiotherapy and
incorporating trunk exercises to enhance functional outcomes and reduce Trunk
deviation and improve gait with augmented feedback low-cost visual gait mat
exercise to improve spatiotemporal parameters of gait in stoke patients.
Objective:
Effect of Trunk exercises augmented with visual gait mat on
trunk asymmetry in stroke patients
Effect of Trunk exercises augmented with visual gait mat on
spatiotemporal parameters of gait in stroke patients.
Methods:
stroke subjects with Trunk asymmetry and deviation in spatiotemporal
parameters of gait will be recruited and will be randomly assigned to
experimental and control groups. Experimental Group will receive trunk exercises and
exercises on visual gait mat in addition to conventional exercise programs
and control group will receive conventional exercise and trunk exercise
protocol.
Expected Outcome:
We expect significant improvements in functional outcomes and a reduction in Trunk
deviation and improvement in spatiotemporal parameters of gait in the
experimental group, compared to the control group.
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