| CTRI Number |
CTRI/2025/07/090626 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| 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
|
Forced-Movement along with Robotic-Movement Therapy in Persons with Stroke |
|
Scientific Title of Study
|
Modified Constraint-Induced Movement Therapy with Robotics in Upper Limb Motor Recovery in Persons with Stroke: A Randomized Controlled 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 |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room no 5, Physical Medicine & Rehabilitation (PMR) OPD, Department of PMR,
All India Institute of Medical Sciences, Bhubaneswar
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 |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room No 5, Physical Medicine & Rehabilitation (PMR) OPD, Department of Physical Medicine & Rehabilitation, All India Institute of Medical Sciences, Bhubaneswar
ORISSA 751019 India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room No 5, Physical Medicine & Rehabilitation (PMR) OPD, Department of Physical Medicine & Rehabilitation, All India Institute of Medical Sciences, Bhubaneswar
ORISSA 751019 India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar, Sijua, PO Dumuduma, Dist Khurda, India, PIN 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, PO Dumuduma, Dist Khurda, PIN: 751019, India |
| 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 |
Advanced Gait Training Lab |
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, PO Dumuduma Khordha ORISSA |
9438884211
apurvaa23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, 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: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (RA-mCIMT 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. The unimpaired/ normal UL will be restrained with UL splint/ padded mitten for 6 hours / day (including robotic therapeutic session and the home program). |
| Comparator Agent |
Group II (mCIMT (Control Group)) |
Participants will receive manual (therapist guided) UL therapy (mCIMT) training for 1 hour for five days per week, for a total of three weeks (total 15 sessions), under supervision. The unimpaired/ normal UL will be restrained with UL splint/ padded mitten for 6 hours / day (including manual manual (physical therapy) training session and the home program)). |
|
|
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 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)
|
|
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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 |
| The Upper Limb 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) 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 Upper Limb 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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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 - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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 15-12-2026 and end date provided 15-01-2035?
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
|
Stroke is a leading cause of acquired adult disability, with around 80% of persons with stroke suffering from upper limb (UL) motor impairments. Among them, only a small percentage (12%) of persons achieve full arm function following UL rehabilitation training, which highlights the need for further research in this area. The extent of UL impairment in stroke is one of the independent determinants of basic activities of daily living (ADL), so improving UL motor function is one of the central areas to focus on. Studies have reported many therapeutic techniques for UL training. Among them, two techniques, constraint-induced movement therapy (CIMT) and other robot-assisted movement therapy (RAMT), have demonstrated better outcomes compared to other existing options. Both these techniques aim to improve UL function by the neural plasticity principle through repetitive task-specific training. It is already well established that robotic training has the capacity to provide a greater number of repetitions in a particular task-specific activity. The robotic training can provide more motivation and keep people engaged in task-specific training. However, this robotic training has limitations. The task-activity training is being given in an artificial, mechanized environment. Therefore, the improvement achieved during an artificial, mechanized environment may fail to translate into a realistic environment. Studies have reported that restraining the healthy/less-affected arm during forced-movement training of the impaired arm has a more beneficial effect than forced, repeated use of the impaired UL without restraint. The CIMT training involves restraining the less-impaired UL during most waking hours. Compared to forced-use, the CIMT training causes better white matter integrity. The CIMT training promotes better angiogenesis, nerve regeneration, and nerve function recovery. However, the main disadvantage of CIMT training is that CIMT training cannot precisely control the movement pattern during task-specific activity training and fails to keep the person motivated throughout the training period. In contrast, RA-MT provides continuous training with correct movement patterns and visual stimulation/feedback through exergaming technology, which helps the person to keep engaged in training. To address the limitations of each technique, we propose a new therapeutic approach, robot-assisted modified constraint movement therapy (RA-mCIMT), which combines the principles of CIMT and RA-MT. This new technique involves structured, functional movement training with the robot instead of therapist-assisted UL training during CIMT therapy for one hour, with the healthy/less impaired UL restrained during the robotic training and most waking time. By combining the strengths of CIMT and RAMT, we assume that RA-mCIMT training will provide better motor recovery than mCIMT in UL following stroke. |