| CTRI Number |
CTRI/2025/07/090342 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Repeated Manual Hand function Training Versus Hand function Training with Robotics in Persons with Stroke |
|
Scientific Title of Study
|
Robot-Assisted Training Versus Enhanced Upper Limb training in Upper Limb Recovery following Stroke: A Randomized Clinical 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 |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar, Odisha |
| Address |
Room no 5, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Sijua
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar, Odisha |
| Address |
Room no 5, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Sijua
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar, Odisha |
| Address |
Room no 5, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Sijua
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Sijua, PO Dumuduma, PIN: 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
AIIMS, Bhubaneswar, Sijua, PO Dumuduma, PIN: 51019 |
| 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 Apurba Barman |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
Room no 5, Physical Medicine & Rehabilitation (PMR) OPD, Department of physical medicine and rehabilitation, AIIMS, Bhubaneswar
Khordha
ORISSA |
9438884211
apurvaa23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I [(RAT Group)] |
Participants will receive robotic-assisted training (RAT) with for 1 hour (with Robotic Machine “Armeo Spring”) for five days per week, for a total of three weeks (total 15 sessions), under supervision. |
| Comparator Agent |
Group II [EULT Group] |
Participants will receive manual (therapist guided) enhanced Upper Limb therapy (EULT) for 1 hour for five days per week, for a total of three weeks (total 15 sessions), under supervision. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Stroke occurred within six months
2. 1st episode of stroke
3. Age between 35 to 75 years, hemodynamically stable.
4. Mild or no cognitive Deficit [Mini Mental Status Examination (MMSE) score more than 21 points)
5. Presence of minimal voluntary active shoulder (abduction and flexion) and elbow (flexion) (at least 10-20 degree active ROM at shoulder abduction and flexion and elbow movements (10-20 degree active flexion)
6. Presence of spasticity in the elbow flexors of grade one plus (1+) or more in the Modified Ashworth scale (MAS)
|
|
| ExclusionCriteria |
| Details |
1. Recurrent strokes
2. Presence of neuropathic pain in the affected upper limb
3. Presence of contractures of the affected wrist and fingers
4. Severe spasticity of the affected limb (MAS more than 3)
5. Cognitive dysfunction (Mini Mental Status Examination (MMSE) score less than 21 points)
6. Hemodynamically unstable patients
7. Presence of previous neurological disorder (due to any etiology) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function. |
Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upper Limb Function: Upper limb (UL) function will be assessed with hand-function (HF) domain score of Stroke Impact Scale (SIS) and The Wolf Motor Function Test (WMFT). |
Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up). |
| Quality of life (QoL): QOL will be assessed with SIS scale. |
Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up). |
| Spasticity of UL: UL Spasticity will be assessed with modified Ashworth Scale (MAS) at elbow and wrist. |
Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up). |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/07/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included ctri.nic.in).
- For how long will this data be available start date provided 03-12-2026 and end date provided 25-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Upper limb (UL)
rehabilitation in stroke patients remains a challenge. Many clinical trials showed significant advances in upper limb recovery with the use of a variety of sensory-motor techniques, i.e., intensive repetitive movements, functional electric stimulation, and constraint-induced movement therapy. But the recovery
rates of UL rehabilitation trials are largely insignificant.
Recently, rehabilitation programs with robot-assisted devices have reported greater improvements in hand functional recovery. These robotic devices can provide
consistent training with high-intensity, repetitive, and task-specific
exercises with visual simulations, which conventional therapies could not
provide. Patients are also motivated by the devices as they simulate real-life
activities with audio-visual feedback.
After reviewing the
literature, it was found that many of these trials had very small sample
sizes, a large number of dropout participants, and a few studies have evaluated
the functional efficacy of robot-assisted therapy on stroke rehabilitation in clinical
settings. To date, no such studies have been done in Indian settings for evaluation of the effectiveness of robotic rehabilitation programs in stroke survivors. The primary objective of the study was to compare the
efficacy of robot-assisted therapy (RAT) and enhanced upper limb therapy
(EULT) in UL motor recovery in stroke patients. Secondary objectives were (1) to compare the efficacy of robot-assisted therapy
(RAT) and EULT in UL functional recovery, and (2) to compare the quality of life (QoL) following
RAT and EULT in patients with stroke. |