| CTRI Number |
CTRI/2024/11/077143 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Comprehensive Bilateral Training Protocol on Motor recovery in post-Stroke Hemiplegia |
|
Scientific Title of Study
|
Effect of Comprehensive Bilateral Training Protocol on Motor recovery in post-Stroke Hemiplegia- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Lalchand Harjpal |
| Designation |
Assistant Professor |
| Affiliation |
RAVI NAIR PHYSIOTHERAPY COLLEGE |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, DU
Sawangi , Meghe, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9438681990 |
| Fax |
|
| Email |
pallaviharjpal26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Lalchand Harjpal |
| Designation |
Assistant Professor |
| Affiliation |
RAVI NAIR PHYSIOTHERAPY COLLEGE |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, DU
Sawangi , Meghe, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9438681990 |
| Fax |
|
| Email |
pallaviharjpal26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHAMMAD IRSHAD QURESHI |
| Designation |
Professor |
| Affiliation |
RAVI NAIR PHYSIOTHERAPY COLLEGE |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, DU, Sawangi , Meghe, Wardha, Maharashtra, India
Sawangi , Meghe, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Datta Meghe Institute of Higher Education and Research, D.U., Sawangi, Meghe,
Wardha, Maharashtra, 442007 |
| 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 |
| Dr Pallavi Harjpal |
RAVI NAIR PHYSIOTHERAPY COLLEGE |
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA |
09438681990
pallaviharjpal26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I602||Nontraumatic subarachnoid hemorrhage from anterior communicating artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional group |
The participants in this group will undergo 20 min of lower limb training to affected side only daily, 5 days per week for 6 weeks. It will be performed by a physiotherapist. It will comprise the Motor Relearning Programme and PNF, which includes task specific training and multiplanar movements of affected lower extremity and upper extremity. |
| Intervention |
Strength training group |
The participants in this group will receive bilateral lower limb training which would include the task-oriented approach i.e., Motor Relearning Programme and PNF for the affected side and strengthening of the less affected side. The participants in this group will undergo 20 min of lower limb training and upper limb to affected side only and 20 min of strength training to the less affected side for 5 days per week for 6 weeks provided by a physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A cerebrovascular illness diagnosed by CT or MRI with Unilateral, primary, or prior onset without lingering neurological impairment and those who are in the sub-acute phase of stroke diagnosed with hemiparesis or hemiplegia after a single stroke history and who have an ability to understand and follow instructions.
|
|
| ExclusionCriteria |
| Details |
Those diagnosed with Brainstem stroke and MCA stroke, with a history of transient ischemic attack (TIA), who have joint or muscular problem arising from condition other than stroke with any unstable cardiovascular condition, as determined by the physician and diagnosed with the failure of vital organs, such as lung, heart, kidney and liver. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. Fugl Mayer Assessment Lower Extremity
|
Baseline and 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| B. Brunnstrom stages of recovery (BRS) |
Baseline & 6 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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Current rehabilitation strategies predominantly emphasize
unilateral training to restore motor function in the affected limb. However,
this approach may inadvertently neglect the unaffected limb, which can lead to
muscle atrophy, decreased motor control, and reduced functional capacity. The
consequent motor deprivation in the unaffected limb not only compromises
overall motor symmetry but also impedes the patient’s ability to engage in
activities of daily living.
|