| CTRI Number |
CTRI/2025/03/083658 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effectiveness of robotic
hand glove assisted mirror therapy versus standard mirror therapy on motor recovery in
upper limb among post- stroke patients |
|
Scientific Title of Study
|
A Randomized controlled trial to evaluate the effectiveness of robotic
hand glove assisted mirror therapy versus standard mirror therapy on motor recovery in
upper limb among post- stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhiraj M R |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS BHOPAL |
| Address |
Room No. 45, Department of Physical Medicine & Rehabilitation, AIIMS Bhopal, Saket Nagar, Bhopal,Madhya Pradesh
Flat No. 315/B Block, Dwarika Parisar, Bagmugaliya, BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8139836760 |
| Fax |
|
| Email |
abhimr.raj95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vithal P Puri |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BHOPAL |
| Address |
Room No. 45, Department of Physical Medicine & Rehabilitation, AIIMS Bhopal, Saket Nagar, Bhopal,Madhya Pradesh
Flat No. 315/B Block, Dwarika Parisar, Bagmugaliya, BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8249709973 |
| Fax |
|
| Email |
puri.pmr@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhiraj M R |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS BHOPAL |
| Address |
Room No. 45, Department of Physical Medicine & Rehabilitation, AIIMS Bhopal, Saket Nagar, Bhopal,Madhya Pradesh
Flat No. 315/B Block, Dwarika Parisar, Bagmugaliya, BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8139836760 |
| Fax |
|
| Email |
abhimr.raj95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 45, Department of Physical Medicine & Rehabilitation, AIIMS Bhopal, Saket Nagar, Bhopal,Madhya Pradesh PIN Code -462020,
Contact No. : 0755-2672332 |
|
|
Primary Sponsor
|
| Name |
AIIMS BHOPAL |
| Address |
Room No. 45, Department of Physical Medicine & Rehabilitation, AIIMS Bhopal, Saket Nagar, Bhopal,Madhya Pradesh, India 462020 |
| Type of Sponsor |
Government 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 ABHIRAJ M R |
AIIMS BHOPAL |
Room No. 45, Department of Physical Medicine & Rehabilitation
Bhopal
MADHYA PRADESH |
08139836760
abhimr.raj95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC SR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
robotic
hand glove assisted mirror therapy |
A therapeutic intervention that uses a
wearable, soft robotic glove designed to assist individuals with impaired hand function. The
glove incorporates flexible materials, actuators, and sensors to provide passive or active support
in performing hand movements. It integrates the mirror therapy concept with robotic
technology, using a glove equipped with sensors and actuators. This glove can stimulate
movement in the patients affected hand while they observe their healthy hands movement in
the mirror
Total Duration is 20 min
frequency will be 3 times in a month with gap of 14 days (0 week, 2 week, 4 week) |
| Comparator Agent |
Standard Mirror therapy |
A therapeutic technique used to improve motor function in
patients with neurological impairments, particularly those experiencing stroke-related motor
deficits. The therapy involves the use of a mirror to create the illusion that the affected limb is
moving normally, thereby stimulating the brains motor areas and promoting recovery
Total Duration is 20 min
frequency will be 3 times in a month with gap of 14 days (0 week, 2 week, 4 week) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosedstroke by clinical assessment and neuroimaging as defined by the
International Classification of Diseases (ICD-11)
Any gender aged between 18 and 70 years
Primary stroke,stroke course of less than 6 months
Vitally stable patients
No cognitive impairment(MMSE score of 24 or above)
Sufficient hearing and visual perception
Intact skin of the affected upper limb
Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
Severe comorbidites that prevents patients from cooperating with treatment
Spasticity of the affected upper limb Modified Ashworth scale (MAS) more than 2
Bone fracture and Joint contracture of affected upper limb |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of robotic hand glove assisted mirror therapy (RMT) versus
standard mirror therapy (MT) on motor recovery in upper limb among post-stroke patients |
after 2 weeks and 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness between robotic hand glove assisted mirror therapy (RMT)
versus standard mirror therapy (MT) on motor recovery in upper limb among post-stroke
patients |
After 2 weeks and 4 weeks of intervention |
To evaluate the improvement in activity of daily living (ADL) among robotic hand glove
assisted mirror therapy (RMT) versus standard mirror therapy (MT) group using the Upper
Extremity Functional Scale (UEFS) |
After 2 weeks and 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/04/2025 |
| 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="2"
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
|
this study has the potential to provide new insights into effectivenesss of advanced rehabilitaion technologies leading to better outcomes for post stroke patients and enhancing clinical practices in stroke rehabilitation |