| CTRI Number |
CTRI/2016/09/007248 [Registered on: 07/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
23/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of unaffected arm in paralytic patients |
|
Scientific Title of Study
|
Role of less affected upper extremity in post stroke rehabilitation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shanta Pandian |
| Designation |
Suptd. OT OPD |
| Affiliation |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped |
| Address |
Room no. 24, Department of Occupational Therapy, Pt. Deeendayal Upadhyaya Institute for the Physically Handicapped 4 V D Marg New Delhi-2
New Delhi
DELHI
110002
India |
| Phone |
9899897408 |
| Fax |
|
| Email |
shantapandian@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shanta Pandian |
| Designation |
Suptd. OT OPD |
| Affiliation |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped |
| Address |
4 V D Marg New Delhi-2
New Delhi
DELHI
110002
India |
| Phone |
9899897408 |
| Fax |
|
| Email |
shantapandian@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shanta Pandian |
| Designation |
Suptd. OT OPD |
| Affiliation |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped |
| Address |
4 V D Marg New Delhi-2
New Delhi
DELHI
110002
India |
| Phone |
9899897408 |
| Fax |
|
| Email |
shantapandian@ymail.com |
|
|
Source of Monetary or Material Support
|
| Pt Deendayal Upadhyaya Institute for the Physically Handicapped |
|
|
Primary Sponsor
|
| Name |
Pt Deendayal Upadhyaya Institute for the Physically Handicapped |
| Address |
4 VD marg New Delhi-2 |
| Type of Sponsor |
Other [Government Institution] |
|
|
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 |
| Shanta Pandian |
Pt. Deendayal Institute for the Physically Handicapped |
Room no. 23, Department of Occupational Therapy, Pt. Deendayal Upadhyaya Institute for the Physically Handicapped 4 VD Marg New Delhi-2
New Delhi
DELHI |
9899897408
shantapandian@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt. Deendayal Upadhyaya Institute for the Physically Handicapped |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post Stroke Hemiparetic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Controlled Occupational tyherapy |
Controlled Occupational therapy protocl based on brunnstroms movement therapy, NDT using departmental activities. Twenty four treatment sessions (2-3/ week; 1 hour each) will be carried out over a period |
| Intervention |
motor training involving the less-affected side (MTLA) |
MTLA is a program for the less affected upper and lower limbs of poststroke subjects. The program utilized progressive resistive exercises (PRE) and bimanual-task training.
Twenty four treatment sessions (2-3/ week; 1 hour each) will be carried out over a period of 2 months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
40 to 60 year, both male & female, Hemiparesis (right / left), unilateral stroke (Ischemic / hemmorhagic), 4 to 12 months after stroke |
|
| ExclusionCriteria |
| Details |
Receptive communication disorder, Cerebellar or thalamic infarct, Uncontrolled systemic or cardiovascular disease, multiple stroke, Ataxia, Severe cognitive / perceptual deficit |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer assessment, Purdue peg board test, Minnesota rate of manipulation test (MRMT) |
pre, at 6th week post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| brunnstrom recovery stage, MMT grades |
pre, at 6th week post intervention |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/09/2012 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Motor impairment of the ipsilesional body side in post-stroke subjects. Shanta Pandian & Kamal Narayan Arya. Journal of Body work & Movement therapy (Elsevier): 2013 Oct;17(4):495-503 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: The damage of some fibers of the corticospinal tract may lead to
mild to moderate impairment on sound side also. The sound side (the
"unaffected" side) is often considered a reference point.
It is therefore assumed that this side has no deficit. Nevertheless,
previous research suggests or tends to show diminished strength in
the unaffected upper limb when compared with
healthy subjects. However, the rehabilitation protocols emphasized only on the
affected side. In spite of this majority of the stroke population do not achieve
complete or satisfactory motor recovery of the affected side. Animal studies have shown that the retraining
of the less affected side also, leads to better cortical reorganization which
in turn add up to improved motor
recovery of the affected upper limb.
Objectives
·
To
study the level of impairment in less affected upper extremity of stroke
patients
·
To
compare the preference between dominant
and non-dominant less affected hand
·
To
develop Occupational therapy intervention protocol focused on intralimb
(bilateral upper limb) coordination and exclusive strengthening & dexterity
training of the less affected side
·
To
study the effect of the protocol in comparison to the conventional program
Methodology
Study
Design: Part- I
Comparison of less affected upper limb of post stroke patients with
matched able body individuals (Non-experimental: observational). Part-II
Comparison of the new treatment protocol with the conventional (experimental;
randomized controlled trial) Place of study: Department of Occupational Therapy, PDUIPH
Inclusion
criteria: Age: 40 to 60 year, both
male & female, Hemiparesis
(right / left), unilateral stroke
(Ischemic / hemmorhagic), 4 to 12 months after stroke
Exclusion
criteria: Receptive communication
disorder, Cerebellar or thalamic
infarct, Uncontrolled
systemic or cardiovascular disease,
multiple stroke, Ataxia, Severe
cognitive / perceptual deficit
Sample
size: 30 post stroke
patients (Pilot study) and 30 matched able body individuals (All
the participants will be enrolled after obtaining signed informed consent form)
Sampling
Method: Sample of convenience, Random assignment
Outcome
measures: Purdue peg board test, Minnesota rate of
manipulation test (MRMT) (Both the
measures are already available in the Department of Occupational therapy,
PDUIPH
Deliverable
outcomes
·
The
present study will lead to development of rehabilitation protocol which
encompasses less affected side also.
·
Assessment
and training of less affected upper extremity will enhance better motor and
functional outcome in post stroke survivors. |