| CTRI Number |
CTRI/2022/01/039488 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
16/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess squatting, kneeling and cross sitting in stroke patients. |
|
Scientific Title of Study
|
A Study to Assess Ground Level Activity in Stroke Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetna Lingraj Kunti |
| Designation |
MPT Scholar |
| Affiliation |
MGM Institute of Health Sciences |
| Address |
Department of Neurophysiotherapy, MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9145249749 |
| Fax |
|
| Email |
chetnakunti82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Ghosh PT |
| Designation |
HOD- Neuro-physiotherapy Department |
| Affiliation |
MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9916273631 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Ghosh PT |
| Designation |
HOD- Neuro-physiotherapy Department |
| Affiliation |
MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9916273631 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,MGM School of Physiotherapy, MGM Institute of Health Sciences |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Sector 1, Kamothe, Navi Mumbai 410209 Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chetna Kunti |
MGM Institute of Health Sciences |
Department of Neurophysiotherapy, MGM Hospital, Sector 1, Kamothe, Navi Mumbai 410209
Raigarh
MAHARASHTRA |
9145249749
chetnakunti82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Recognition Committee of Mahatma Gandhi Missions Dental College and Hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. MCA territory Stroke – subacute and chronic (3 weeks – 24 weeks)
2. Functional independence measure score: ≥100
3. Brunnstorm Stage of lower extremity: stage 3 – stage 6
4. Participants speaking Hindi/Marathi/ English language
|
|
| ExclusionCriteria |
| Details |
1. Hearing deficit
2. Recent injuries
3. Memory loss(Amnesia)
4. Aphasia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Score of MGM Ground Level Activity Exposure questionnaire
2.Range of motion of lower extremities
3.Commander Muscle tester - Strength of Lower extremities muscles
4.Modified Ashworth Scale |
At time of first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Berg balance Scale score |
At time of first visit |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke (Cerebrovascular Accident) is
sudden loss of neurological functions caused by interruption of the blood flow
to the brain. As a result patient’s shows sensory, motor, cognitive and
language dysfunction. These impaired functions can affect their activity of
daily living. These activity also includes; squatting, cross-leg sitting,
kneeling, etc. in which research investigation is scarce. Understanding the
importance and the factors related to ground level activities, perceived by
patients with stroke can guide clinicians in selecting relevant, patient valued
treatment, outcomes measures and may develop appropriate intervention
strategies. Hence, this study focus to assess ground level activity in stroke
patients.
The current study will emphasis to
determine the quality and quantity of ground level activity and the factors
affecting these activities in stroke patients. 30 stroke patients will be
included in the study according to inclusion and exclusion criteria. Study
protocol will be explained to the patients and written informed consent will be
signed. Demographic data of the patients will be documented. Assessment of MGM
Ground Level Activity Exposure Questionnaire, Strength of lower extremities,
range of motion of lower extremities , tone and Berg balance scale will be
recorded and analyzed.
Statistical analysis will be done using SPSS software ( version
24). |