| CTRI Number |
CTRI/2017/08/009235 [Registered on: 02/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of trunk (body) muscle strength and balance confidence during daily activities after stroke. |
|
Scientific Title of Study
|
Correlation of trunk control to trunk muscle strength and balance confidence in chronic stroke. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthikbabu S |
| Designation |
Associate Professor |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, A Constituent College of Manipal University, Manipal Hospital, HAL Airport Road,
Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthikbabu S |
| Designation |
Associate Professor |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, A Constituent College of Manipal University, Manipal Hospital, HAL Airport Road,
Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthikbabu S |
| Designation |
Associate Professor |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, A Constituent College of Manipal University, Manipal Hospital, HAL Airport Road,
Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Health Sciences, A Constituent Institute of Manipal University, Manipal Hospital,
98, HAL Airport Road, Bangalore - 560017, Karnataka. |
|
|
Primary Sponsor
|
| Name |
SOAHS Manipal University |
| Address |
Department of Physiotherapy Manipal Hospital, HAL Airport Road, Bangalore. |
| 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 |
| Karthikbabu S |
Manipal Hospital |
Dept. of Physiotherapy,
School of Allied Health Sciences, A Constituent Institute of Manipal University, Manipal Hospital, HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA |
9902338198
karthikbabu78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Reseach Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Post stroke duration beyond 6 months.
2) Unilateral supra-tentorial stroke lesion.
3) Ability to understand simple verbal instructions.
4) Ability to cross 10-meter distance using or not using walking aid. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Trunk control using Trunk Impairment Scale 2.0
2) Trunk muscle strength of flexor, extensor, flexion-rotator and lateral flexor using handheld dynamometer.
3) Activity specific Balance Confidence (ABC) scale
|
The measures were collected at single time point with 5 minutes rest in between them. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2014 |
| Date of Study Completion (India) |
16/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aimed to test the trunk control in people after stroke and its correlation with trunk muscle strength and balance confidence during daily activities. Study findings showed that the trunk performance was poor in people with stroke and it was postively related to trunk mucle weakness and the balance confidence capacity. This study addresses the need to include trunk control and strength regimes during rehabilitation so that stroke patients could participate their daily functioning with better balance confidence. |