| CTRI Number |
CTRI/2010/091/000459 [Registered on: 31/05/2010] |
| Last Modified On: |
09/05/2015 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Meaningful task specific training for evaluation of functional and neuroplastic changes in post Stroke patients |
|
Scientific Title of Study
|
Meaningful task specific training for evaluation of functional and neuroplastic changes in post Stroke patients |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof. Rajesh Verma |
| Designation |
|
| Affiliation |
|
| Address |
Department of Neurology
CSMMU(KGMU)
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
08127442407 |
| Fax |
|
| Email |
drrajeshverma32@yahoo.com, kamalnarya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Rajesh Verma |
| Designation |
|
| Affiliation |
|
| Address |
Department of Neurology
CSMMU(KGMU)
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
08127442407 |
| Fax |
|
| Email |
drrajeshverma32@yahoo.com, kamalnarya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Rajesh Verma |
| Designation |
|
| Affiliation |
|
| Address |
Department of Neurology
CSMMU(KGMU)
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
08127442407 |
| Fax |
|
| Email |
drrajeshverma32@yahoo.com, kamalnarya@yahoo.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof. Rajesh Verma |
Dept. of Neurology, CSMMU, Lucknow, UP, India. |
CSMMU,-226003
Lucknow
UTTAR PRADESH |
08127442407
kamalnarya@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMMU Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Post Stroke subjects with hemiperesis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional rehabilitation (Brunnstrom & Bobath) |
|
| Intervention |
Meaningful Task Specific Training (MTST) |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Age: 18 to 60 year, both male & female
Hemiparesis (both right & left)
unilateral stroke
Normal one side vision
Able to cope with intensive training program
Medically stable
Able to understand instructions
4 to 24 weeks after stroke
Modified Ashworth Scale - 1,1+, 2,
Brunnstrom Recovery Stage-Arm-2,3,4 & 5
Functional Ambulation Classificatio- I & above
|
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| ExclusionCriteria |
| Details |
Severe Aphasia (NIHSS*- 2 & 3)
Cerebellar or thalamic infarct
Uncontrolled systemic or cardiovascular disease
Fixed contractures
Shoulder subluxation
Cortical blindness (NIHSS - 2 & 3)
Multiple stroke
Ataxia
Severe sensory loss (NIHSS -2)
Dementia
Participation in any Pharmacological trial
Severe depression
*(National Institutes of Health Stroke Scale-NIHSS)
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Fugl Meyer Assessment (FMA)
Action Research Arm Test (ARA)
Motor Activity Log (MAL)
Wolf Motor Function Test (WMFT) |
Pre intervention, Post intervention, Follow up after 4 week |
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Secondary Outcome
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| Outcome |
TimePoints |
| Stroke Impact Scale (SIS) |
Pre intervention, Post intervention, Follow up after 4 week |
|
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Target Sample Size
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Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/12/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Stroke remains a leading cause of disability in many countries including India. It can cause deficits in a number of neurologic domains, most commonly in the motor system.Standard motor rehabilitation after hemiparetic stroke typically involves an eclectic mix of approaches.
However no therapeutic method gives remarkable improvement for motor deficit, making motor rehabilitation for stroke a major challenge.Further there is no strong clinical & research evidence for these methods.
Task-specific training which focuses on the practice of skilled motor performance is the critical link to facilitate neural reorganization and "rewiring" in the central nervous system (CNS)
Numerous studies have been done on task specific training; however type of task and specific method of training which can lead to better functional and neuroplastic changes in stroke patients has not been established yet.
Hence there is need to develop more specific training methods based on meaningful task which would lead to better functional and neuroplastic changes in Stroke patients.
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