| CTRI Number |
CTRI/2025/12/099543 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Hand-Arm Bimanual Intensive Therapy (HABIT) And Robotic Hand Therapy (RHT) In Improving Hand Functions And Quality Of Life After Stroke |
|
Scientific Title of Study
|
Assessing The Effectiveness Of Hand-Arm Bimanual Intensive Therapy (HABIT) Versus Robotic Hand Therapy (RHT) In Improving Fine Motor Control And Quality Of Life Among Stroke Survivors - A Comparative 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 |
Harshitha B N |
| Designation |
Post-Graduate Student, MPT-Adult Neurosciences |
| Affiliation |
College Of Physiotherapy, School of Health Sciences, Dayananda Sagar University |
| Address |
College Of Physiotherapy, School of Health Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, South Bengaluru Dt, Karnataka
Bangalore
KARNATAKA
562112
India |
| Phone |
6361270963 |
| Fax |
|
| Email |
harshithabn248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Bhat |
| Designation |
Assistant Professor |
| Affiliation |
College Of Physiotherapy, School of Health Sciences, Dayananda Sagar University |
| Address |
College Of Physiotherapy, School of Health Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, South Bengaluru Dt,Karnataka
Bangalore
KARNATAKA
562112
India |
| Phone |
6364369412 |
| Fax |
|
| Email |
aditibhat1293@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagrruthi NS |
| Designation |
Assistant Professor |
| Affiliation |
College Of Physiotherapy, School of Health Sciences, Dayananda Sagar University |
| Address |
College Of Physiotherapy, School of Health Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, South Bengaluru Dt,Karnataka
Bangalore
KARNATAKA
562112
India |
| Phone |
9108083906 |
| Fax |
|
| Email |
jagrruthisrinivasan@gmail.com |
|
|
Source of Monetary or Material Support
|
| College Of Physiotherapy, School Of Health Sciences, Dayananda Sagar University |
|
|
Primary Sponsor
|
| Name |
College Of Physiotherapy, School Of Health Sciences, Dayananda Sagar University |
| Address |
College Of Physiotherapy, School Of Health Sciences, Dayananda Sagar University,Devarakaggalahalli, Harohalli,South Bengaluru Dt,Karnataka |
| Type of Sponsor |
Other [Private University] |
|
|
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 Aditi Bhat |
College Of Physiotherapy, Neurophysiotherapy OPD, Dayananda Sagar University |
Room No. 11, 2nd floor, Neurology OPD, Dayananda Sagar University, Devarakaggalahalli, Harohalli, South Bengaluru Dt-562112, Karnataka.
Bangalore
KARNATAKA |
6364369412
aditibhat1293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Of Physiotherapy, School Of Health Sciences, Neuro-Physiotherapy OPD, Dayananda Sagar University, Devarakaggalahalli, Harohalli, South Bengaluru Dt, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HABIT+ Conventional Physiotherapy
|
1.After IEC Approval, Screening for eligibility criteria fulfillment using screening tools.
2.Collecting baseline data using
FMA-UE,WFMT and SS-QOL
3.Stratified Random Sampling (I and II)
Group Allocation using Excel (0 Weeks)
4.Group A:HABIT+ Conventional Physiotherapy
5.Post treatment data collection, analysis and interpretation
|
| Comparator Agent |
Nil |
Nil |
| Intervention |
RHT+ Conventional Physiotherapy |
1.After IEC Approval, Screening for eligibility criteria fulfillment using screening tools
2.Collecting baseline data using
FMA-UE,WFMT and SS-QOL
3.Stratified Random Sampling (I and II)
Group Allocation using Excel (0 Weeks)
4.Group B: RHT + Conventional Physiotherapy
5.Post treatment data collection, analysis interpretation
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with single history of supratentorial stroke and are medically stable
Age: 45 years to 75 years
Montreal Cognitive Assessment: Greater than or equal to 21 or 22
Brunnstrom’s Hand Recovery Stage: Greater than or equal to 4
Modified Ashworth Scale: 1 and 1 plus and 2 |
|
| ExclusionCriteria |
| Details |
No history of other neurological conditions like movement disorders and cerebellar dysfunctions.
No history of other Upper Extremity MSK conditions or CVD
No history of Upper Extremity surgery or Upper Extremity BOTOX which interferes with result of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fugl-Meyer Assessment Upper Extremity
2.Wolf Motor Function Test |
0 week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Stroke Specific Quality of Life |
0 week and 4th week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/01/2026 |
| 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="0"
Months="6"
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
|
Assessing The Effectiveness Of Hand-Arm Bimanual Intensive Therapy (HABIT) Versus Robotic Hand Therapy (RHT) In Improving Fine Motor Control And Quality Of Life Among Stroke Survivors - A Comparative Study
Impaired fine motor control of the hand is a common consequence of stroke and significantly impacts functional independence and quality of life. Hand-Arm Bimanual Intensive Therapy (HABIT) and Robotic Hand Therapy (RHT) are widely used and effective rehabilitation approaches for improving hand function after stroke. However, differences in treatment delivery time, clinical feasibility, and resource requirements highlight the need for comparison. The purpose of this trial is to compare the effects of HABIT and RHT on fine motor control and quality of life in stroke survivors to support efficient and evidence-based rehabilitation planning. |