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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)
 
 
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
  1. 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).

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included ctri.nic.in).

  6. 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.

  7. 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. 

 
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