| CTRI Number |
CTRI/2025/03/081574 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| 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
|
Impact of Soft Robotic Hand Glove Training on Hand Function in Subacute Stroke Patients |
|
Scientific Title of Study
|
Effects Of Soft Robotic Hand Glove Training On Hand Function In Patients With Sub
acute Stroke:An Experimental Study |
| 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 Aditi Ashokkumar Devangare |
| Designation |
Masters of Neurophysiotherapy student |
| Affiliation |
Maharashtra Institute of physiotherapy Latur |
| Address |
Maharashtra Institute Of Department of neurophysiotherapy,OPD-16,Maharashtra Institute Of Physiotherapy,MIMSR Medical Campus,Ambejogai Road,Latur Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9156226783 |
| Fax |
|
| Email |
aditidevangare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of physiotherapy Latur |
| Address |
Maharashtra Institute Of Department of neurophysiotherapy,OPD-16,Maharashtra Institute Of Physiotherapy,MIMSR Medical Campus,Ambejogai Road,Latur Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
797250020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of physiotherapy Latur |
| Address |
Maharashtra Institute Of Department of neurophysiotherapy,OPD-16,Maharashtra Institute Of Physiotherapy,MIMSR Medical Campus,Ambejogai Road,Latur Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
797250020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra institute of physiotherapy,Neuro physiotherapy department OPD no-16 MIMSR campus,Ambejogai Road , Latur 413 531 , India |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of physiotherapy Latur |
| Address |
Maharashtra Institute of physiotherapy,MIMSR medical campus,Ambejogai road,Latur 413531 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAditi Ashokkumar Devangare |
Maharashtra Institute of physiotherapy Latur |
Maharashtra Institute of physiotherapy Neuro physiotherapy department OPD no -16 Medical Campus MIMSR, Ambejogai Road,Latur
Latur Maharashtra Latur Maharashtra
Latur
MAHARASHTRA |
09156226783
aditidevangare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subject |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1)Conventional therapy (3 times in a week for 6 weeks) |
2)Conventional therapy,
1-Electrical muscle stimulator 2-Hand exercises |
| Intervention |
1)Soft Robotic Hand Glove Training.(3 times in a Weekfor 6 weeks)
2)Conventional therapy.(3 times in a week for 6 weeks) |
1)soft robotic hand glove, there are 3 modes.
1-passive training mode
2-mirror training
3-interactive game training
2)Conventional therapy
1-Electrical muscle stimulator 2-Hand exercises
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Subacute stroke subjects both male and female between age group of 55 to 70 years.
2) Brunnstrom stage of hand recovery from grade 2 and above.
3) Hemorrhagic stroke and ischemic stroke.
4) Subjects with no cognitive impairment, mini mental status examination score (MMSE) more than 24. |
|
| ExclusionCriteria |
| Details |
1)Recent surgery or trauma of head, neck and upper extremity.
2) Subjects diagnosed with mental disorders.
3) Contracture of hand.
4) Subjects with impairment of sight, hearing and
comprehension. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Action Research Arm Test
|
At pre, 3rd week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Brunnstrom stage of hand recovery. |
At pre, 3rd week and 6th week |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
26/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Subjects will be screened as per the inclusion and exclusion criteria. Aim, objectives & treatment procedure will be explained to the participants. written and informed consent will be taken. Then subjects will be randomly allocated into two groups Group A (Experimental Group) & Group B (control Group). Necessary data will be taken from participants on a data collection sheet. GROUP A – Will include 22 participants receiving 30 minutes of soft robotic hand glove training for 3 days / week for 6 weeks. Along with conventional therapy. In soft robotic hand glove, there are 3 modes. 1-passive training mode the rehabilitation glove can drive the affected hand to execute flexion, extension exercise. 2.mirror training – under the exercise of mirror training with the help of robotic glove, the healthy hand drives the affected hand to move synchronously. 3.interactive game training - multi-interactive hand and brain combined games enhance the immersion of hand rehabilitation. Patients can also adjust the difficult of the game according to hand movements. Each mode will be given for 10 minutes. Group A will also receive conventional physiotherapy treatment which is electrical muscle stimulator modality will be used on wrist extensor muscles and lumbricals. Dosage will be 35-50 pps pulse frequency,150 – 200 pulse duration, amplitude – sufficient for functional activity, ON and OFF time = 1:3 ratio,10 – 20 reps for 2 set for wrist extensor and lumbricals. GROUP B – will include 22 participants receiving conventional therapy. Conventional therapy – electrical muscle stimulator modality will be used on wrist extensor muscles and lumbricals. Dosage will be 35-50 pps pulse frequency,150 – 200 pulse duration, amplitude – sufficient for functional activity, ON and OFF time = 1:3 ratio,10 – 20 reps for 2 set for wrist extensor and lumbricals. Patients will be assessed before , at the end of 3rdweek and at the end of 6 week with ACTION RESEARCH ARM TEST scale and Brunnstrom stage of recovery for hand as outcome. |