| CTRI Number |
CTRI/2026/02/104749 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which Helps paralysis Patients Use Their Hand Better – Robotic Glove or Mirror Therapy? |
|
Scientific Title of Study
|
Effect of Soft robotic Glove versus Mirror Therapy along with Conventional Physiotherapy on Manual Dexterity, Grip Strength and manual ability among Stroke Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| saburi45 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saburi Goliwar PT |
| Designation |
MPTH |
| Affiliation |
MAEERS PHYSIOTHERAPY COLLEGE TALEGAON DABHADE |
| Address |
A230 Neurophysiotherapy , 2nd Floor,OPD Building, near MIMER Medical College Campus, Talegaon Dabhade station road Talegaon Dabhade 410507. Pune MAHARASHTRA 442401 India |
| Phone |
7083630629 |
| Fax |
|
| Email |
goliwarsaburi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saburi Goliwar PT |
| Designation |
MPTH |
| Affiliation |
MAEERS PHYSIOTHERAPY COLLEGE TALEGAON DABHADE |
| Address |
A230 Neurophysiotherapy , 2nd Floor,OPD Building, near MIMER Medical College Campus, Talegaon Dabhade station road Talegaon Dabhade 410507. Pune MAHARASHTRA 442401 India |
| Phone |
7083630629 |
| Fax |
|
| Email |
goliwarsaburi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saburi Goliwar PT |
| Designation |
MPTH |
| Affiliation |
MAEERS PHYSIOTHERAPY COLLEGE TALEGAON DABHADE |
| Address |
A230 Neurophysiotherapy , 2nd Floor,OPD Building, near MIMER Medical College Campus, Talegaon Dabhade station road Talegaon Dabhade 410507. Pune MAHARASHTRA 442401 India |
| Phone |
7083630629 |
| Fax |
|
| Email |
goliwarsaburi@gmail.com |
|
|
Source of Monetary or Material Support
|
| A230 Neurophysiotherapy , MAEERS Physiotherapy College, Bhausaheb Sardesai Talegaon Rural Hospital(Bstrh), Talegaon Dabhade 2nd Floor,OPD Building, near MIMER Medical College Campus, Talegaon Dabhade station road Talegaon Dabhade 410507. |
|
|
Primary Sponsor
|
| Name |
Dr. Saburi Goliwar PT |
| Address |
Asara Niwas, Dasarwar Wada ,Anchleshwar Ward, Chandrapur, 442401 |
| Type of Sponsor |
Other [Self Financed] |
|
|
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 Saburi Goliwar PT |
Neurophysiotherapy Department MAEERS PHYSIOTHERAPY COLLEGE |
A230,2nd floor OPD Building Near MIMER Medical College Campus Talegaon Station Rd Talegaon Dabhade Maharashtra 410507 Pune MAHARASHTRA |
7083630629
saburigoliwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS Physiotherapy College Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of Soft robotic Glove versus Mirror Therapy along with Conventional Physiotherapy on Manual Dexterity, Grip Strength and manual ability among Stroke Individuals |
CONVENTIONAL WITH MIRROR THERAPY
5 DAYS PER WEEK / 4 WEEK PROTOCOL
1. Wrist flexion and extension, finger flexion and extension, finger adduction, and abduction. 2. Squeezing a sponge ball. 3. Building blocks. 4. Stacking rings. 5. Opposition of thumb with all the fingers. 6. Flipping a card. 7. Placing clothes clips around the rim of a cup. 8. Transferring rice to another cup. 9. Placing pegs on a board. 10. Pick up a coin or bean. 11. Put a block into the bucket. 12. Making balls out of theraputty. 13. Copying shapes on a paper. 14. Coloring a box with crayons 15. Connecting dots with pen |
| Intervention |
Effect of Soft robotic Glove versus Mirror Therapy along with Conventional Physiotherapy on Manual Dexterity, Grip Strength and manual ability among Stroke Individuals |
CONVENTIONAL WITH SYREBO
5 DAYS PER WEEK / 4 WEEKS PROTOCAL
1. Finger flexion.
2. Finger extension
3. Grasping of a spherical ball.
4. Grasping a water glass
5. Transferring pegs to the bucket.
6. Picking up a spherical ball and transferring it into the bucket.
7. Stacking cups.
8. Pouring water from one glass to another.
9. Placing pegs to the peg board.
10. Action of drinking water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Post stroke hemiplegics aged 18 and 65 years
Fugl Meyer Assessment score 30 to 50
Mini Mental State Examination score more than 21
|
|
| ExclusionCriteria |
| Details |
Individuals with bilateral stroke.
Stroke patient with any other diagnosed Neurological and Psychosomatic condition.
Stroke patient with shoulder or arm contracture/pain less than 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Purdue peg board
Fugl- Meyer Assessment
Hand held Dynamometer
ABHILHAND questionnaire |
T0- Baseline assessment done pre intervention
T1- Assessment done post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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 2 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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
|
This study compares the effectiveness of Soft Robotic Glove (SYREBO) therapy and Mirror Therapy, both combined with conventional physiotherapy, in improving hand function among stroke patients. Stroke commonly results in reduced manual dexterity, decreased grip strength, impaired coordination, and difficulty performing daily activities. Early and structured rehabilitation plays a crucial role in restoring upper limb function and promoting independence. The study followed a structured 4-week intervention protocol. Conventional physiotherapy included range of motion exercises, task-oriented training, grip strengthening, balance exercises, and stretching with progressive advancement each week. Group A received additional training using the SYREBO soft robotic glove, which provided assisted and repetitive finger movements to enhance motor relearning and functional grasp. Group B received mirror therapy, where patients performed structured hand activities using visual feedback from the unaffected limb to stimulate motor recovery. Outcome measures used to evaluate effectiveness included the Fugl-Meyer Assessment for motor recovery, the Purdue Pegboard Test for fine motor dexterity, Hand Grip Dynamometer for grip strength, and the ABILHAND Questionnaire for functional hand ability in daily activities. |