| CTRI Number |
CTRI/2018/01/011543 [Registered on: 24/01/2018] Trial Registered Prospectively |
| Last Modified On: |
18/01/2018 |
| 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
|
Efficacy of task-oriented training approach on trunk and hip musculature to improve balance in stroke subjects:a randomised controlled trial. |
|
Scientific Title of Study
|
Efficacy of task-oriented training approach on trunk and hip musculature to improve balance in stroke subjects:a randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratikshya Ray |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Department of Physiotherapy,
Kasturba Medical college,Bejai campus,Mangalore.
KMC, Hill house road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9438019686 |
| Fax |
|
| Email |
prati1995ray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abraham M Joshua |
| Designation |
Senior associate professor |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Department of Physiotherapy,
Kasturba Medical college,Bejai campus,Mangalore.
KMC, Hill house road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pratikshya Ray |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Department of Physiotherapy,
Kasturba Medical college,Bejai campus,Mangalore.
KMC, Hill house road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9438019686 |
| Fax |
|
| Email |
prati1995ray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Light house, Hill road Mangalore.575001 |
| 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 |
| Pratikshya Ray |
KMC Mangalore |
Department of physiotherapy, 5th floor, KMC hospital,Jyoti circle Mangalore.
Dakshina Kannada
KARNATAKA |
9438019686
prati1995ray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stroke subjects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional rehabilitation |
Eligible stroke subjects will be given facilitatory techniques, inhibitory techniques for UL, LL and trunk for 45-60 minutes per day, once daily for 2 week. |
| Intervention |
Task oriented training approach for trunk and hip abductor |
Eligible subjects for intervention group will take conventional method of treatment for UL and LL and Task oriented training approach for trunk and hip abductor to improve balance in stroke for 45-60 minutes per day, once daily for 2 week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Medically stable one time stroke subjects.
2.MMSE score of >23
3.Can sit at least for 30 minutes with support.
4. Trunk control test scoreequal to 100.
5. Brunnstrom recovery stage for lower limb at least grade 3. |
|
| ExclusionCriteria |
| Details |
1.Presence of any musculoskeletal disorder, which might influence the performance.
2.Presence of any neurological disorder apart from stroke.
3.Presence of any cardiopulmonary condition, which may influence the performance.
4.Subjects with hemi neglect, pusher syndrome, severe visual field defects and somatosensory deficit. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Trunk impairment scale
2.Brunel Balance assessment |
Pre intervention and post intervention 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Tinetti performance oriented mobility assessment scale
2. Stroke rehabilitation assessment of movement measures |
pre intervention and post intervention 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2018 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diagnosed stroke subjects, referred by neurologists to the Department of Physiotherapy will be approached.Informed consent will be taken from willing subjects.Eligible subjects after screening of inclusion and exclusion criteria randomised by block randomisation method and they will be explained the purpose of the study. Demographic data and basement measurement will be collected.The participant in group A will receive conventional rehabilitation for affected UL, LL and trunk and group B participants will receive conventional rehabilitation for UL and LL and task oriented training for trunk and hip abductor to improve balance.
The independent blinded assessor will follow standardised procedure for the outcome measures such as Trunk impairment scale, Tinetti performance oriented mobility assessment scale, Brunel balance index , Stroke rehabilitation assessment measure scale. The outcome measure will be randomised for the assessment purpose to minimise the carry over effect.Data will be collected pre intervention and 2 week after treatment post intervention and will be used for analysis. |