| CTRI Number |
CTRI/2021/10/037392 [Registered on: 20/10/2021] Trial Registered Prospectively |
| Last Modified On: |
06/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe whether there is any correlation between core muscle endurance and walking speed in chronic stroke subjects |
|
Scientific Title of Study
|
Correlation of core muscle endurance and gait speed in chronic stroke subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drushti Shrikant Patange |
| Designation |
Post Graduate Student of Physiotherapy |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation,Mumbai |
| Address |
Department of physiotherapy,All India Institute of Physical Medicine and Rehabilitation,Mahalaxmi
Mumbai
MAHARASHTRA
400034
India |
| Phone |
09167971995 |
| Fax |
|
| Email |
drushtipatange07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Wasnik |
| Designation |
Lecturer,Physiotherapy Department |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation,Mumbai |
| Address |
Department of physiotherapy,All India Institute of Physical Medicine and Rehabilitation,Mahalaxmi
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Wasnik |
| Designation |
Lecturer,Physiotherapy Department |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation,Mumbai |
| Address |
Department of physiotherapy,All India Institute of Physical Medicine and Rehabilitation,Mahalaxmi
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
- |
| Email |
sandhyaw5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, All India Institute of Physical Medicine and Rehabilitation,Mumbai |
|
|
Primary Sponsor
|
| Name |
Drushti Shrikant Patange |
| Address |
Department of Physiotherapy,All India Institute of Physical Medicine and Rehabilitation,Mumbai |
| 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 |
| Drushti Shrikant Patange |
All India Institute of Physical Medicine and Rehabilitation |
Room no 207, second floor , physiotherapy department AIIPMR,Mahalaxmi,400034
Mumbai
MAHARASHTRA |
9167971995
drushtipatange07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE,AIIPMR,HAJI ALI, MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)More than 6 months post stroke subjects
2)Chronic stroke subjects scoring minimum of 24 points on mini mental state examination.
3)Chronic stroke subjects capable OF sitting for at least 10 mins unsupported and walk independently with or without assistive device for at least 10 meters.
4)Functional ambulatory category level 5
5)Minimum brunstrom motor recovery stage of 4
6)Both male and female genders no hemiplegic side preference |
|
| ExclusionCriteria |
| Details |
1)Chronic stroke subjects with visual and auditory impairments.
2)Chronic stroke subjects with the history of convulsion disorders who are on medication.
3)Subjects with vestibular disorders,cerebellar diseases, unilateral neglect, apraxia.
4)Chronic stroke subjects with severe musculoskeletal,renal, cardiovascular diseases
5) Subjects with contractures or deformities of hip,knee,ankle.
6)Subjects with neuro-muscular diseases other than stroke. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Core muscle endurance- Pressure Biofeedback Unit
2)10 Meters walk test |
one time assessment
(cross-sectional observational study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
23/10/2021 |
| 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
|
This is a cross-sectional study in which core muscle endurance and gait speed will be assessed in chronic stroke subjects. Total 29 subjects with chronic stroke will be recruited for this study. After assessing the outcome measures ( core muscle endurance - pressure biofeedback unit and 10 meters walk test) the data of both the measures will be analysed. |