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CTRI Number  CTRI/2025/04/084305 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Computer enhanced exoskeleton and robotic rehabilitation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of Exoskeleton to improve function of affected hand in patients with stroke 
Scientific Title of Study   Effectiveness of Gravity supported, Computer enhanced Exoskeleton to Promote Recovery of Upper Limb Function for Patients after Stroke “ A randomized control 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  Dr Vijay Sivaraj 
Designation  Post Graduate registrar 
Affiliation  Christian Medical College, Vellore 
Address  Department of Physical Medicine and Rehabilitation Christian Medical College, Vellore – 4

Vellore
TAMIL NADU
632004
India 
Phone  9585322424  
Fax    
Email  vijaysivaraj98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raji Thomas 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Physical Medicine and Rehabilitation Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  0416-2282158  
Fax    
Email  rajithomas@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vijay Sivaraj 
Designation  Post Graduate registrar 
Affiliation  Christian Medical College, Vellore 
Address  Department of Physical Medicine and Rehabilitation Christian Medical College, Vellore – 4

Vellore
TAMIL NADU
632004
India 
Phone  9585322424  
Fax    
Email  vijaysivaraj98@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, CMC Vellore 
 
Primary Sponsor  
Name  Fluid Research Grant, CMC Vellore 
Address  Department of Physical Medicine and Rehabilitation, CMC Vellore 
Type of Sponsor  Private 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 
Vijay Sivaraj  Rehabilitation Institute  Department of Physical Medicine and Rehabilitation, CMC Vellore
Vellore
TAMIL NADU 
09585322424

vijaysivaraj98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CMC VELLORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I68||Cerebrovascular disorders in diseases classified elsewhere, (2) ICD-10 Condition: I68||Cerebrovascular disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goal directed Exoskeleton based rehabilitation with computer enhanced real time feedback   The intervention group undergoes training of the affected upper limb with Armeospring upper extremity robotic therapy for 45 minutes per day session per day for 10 sessions in the Rehabilitation Robotics Lab. The Armospring supports the weight of the limb while offering negligible resistance to motion. The device will be fitted based on the dimensions of the patient’s arm. Gravity support will be calculated based on the patient’s ability to maintain the arm in a standard position.. Patient is calibrated on the range of active movements on the computer’s working plane. Appropriate training module will be selected by the occupational therapists based on requirement of the patient’s condition. Patient will be asked to do goal directed movements that emphasise shoulder and elbow movements. The patients will be rewarded with points so as to provide motivation to achieve the target and a virtual learning environment is set up 
Comparator Agent  Horizontal and vertical range of motion exercises with exoskeleton fitted with no goal direction and real time feedback  The control group undergoes gravity eliminated horizontal and vertical active range of motion of the affected upper limb for 45 minutes a day for 5 sessions per week for 2 weeks. These exercises are done in the same lab with the exoskeleton fitted on the affected upper limb, but the technology features are not enabled. Varying levels of gravity support of the arm weight, virtual reality games for self training and real time feedback will not be available. There will also not be advancement to more challenging modules. . Following the completion of 10 sessions, the control group will receive 10 sessions of Armeospring rehabilitation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Patients with history of cerebrovascular accident
-Admitted for rehabilitation for a minimum duration of 6 weeks.-Clinical and radiological diagnosis of Ischemic / Haemorrhagic strok,1 month to 2 years after stroke,First episode of stroke,Severe to mild unilateral upper limb paresis of the dominant or non dominant UE,Patients with mild or no cognitive deficit ,Able to sit for 1 hour
 
 
ExclusionCriteria 
Details  -Significant impairment in the vision,Unstable medical conditions,Severe neuropathic pain,Severe spasticity ,Contracture or in the affected UL, coexisting neurological illnesses, Prior botulinum toxin injections , previously participated in robotic therapy in the upper extremities, Pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
-The Upper extremity subscale of the Motricity Index (MI arm)
-Motor Domain Scale of Fugl Meyer Upper Extremity scale
-Action Research Arm test (ARAT)
-Armeospring measures- AROM, AMove
 
Intervention-Baseline,2weeks,1 month, 3month
Control- Baseline,2weeks,1 month, 6 weeks, 3month 
 
Secondary Outcome  
Outcome  TimePoints 
--Modified Barthel Index
-Modified Ashworth Scale
-Patient Global Impression Scale of Change
 
-Modified Barthel Index-baseline, 2 weeks, 1 month, 3 month. For control- 6 weeks in addition
-Modified Ashworth Scale-baseline, 2 weeks, 1 month, 3 month. For control 6 weeks in addition
-Patient Global Impression Scale of Change-at 2 weeks
 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   21/04/2025 
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 Applicable 
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  

Recovery of the impaired upper limb is a crucial felt need and priority for these patients. Hemiparetic upper limb rehabilitation usually focus on compensatory strategies that use the intact upper limb to compensate for the impaired upper limb. With the understanding of neuroplasticity after acquired brain  injury, several new therapies such as  conventional occupational therapy methods, constraint-induced movement therapy (CIMT),  mirror therapy, functional electrical stimulation, mental practice and  virtual reality augmentation  focus on improving the neurologic recovery of the impaired upper limb.

 Recently, robot-assisted therapy (RAT), a technology-based rehabilitation approach, which offers high-intensity, highly repetitive, task-specific UL training with real-time  feedback has been reported as an effective strategy in UL rehabilitation. The ArmeoSpring is a passive instrumented arm orthosis with a spring mechanism for adjustable arm weight support in a 3D workspace, and is helpful for patients who have restricted functions in their upper extremities due to various neurological disorders. Partial relief of the upper limb’s weight and mechanical-assisted therapy in a virtual workspace enables the  patient to produce a larger ROM within a 3-dimensional workspace. This enables repetitive and active exertion of goal-directed movements, with enlarged ROM  during the practice of complex motor tasks in an enriched learning environment.

 In this randomized controlled study, we aim to study the effectiveness of technology enhanced rehabilitation of the upper limb using Armeospring  in sub acute and chronic  stroke patients who have been admitted for inpatien rehabilitation. Patients will be randomized to two groups. The intervention group will receive  ten technology enabled  upper limb training sessions using a gravity supported computer enhanced exoskeleton( Armeospring), while the control group will receive ten sessions of gravity eliminated exercises for the upper limb in the form of horizontal and vertical reach activities, with the exoskeleton fitted, but without activating the technology.  Both groups will also receive the standard conventional therapy. Both the patient and assessors will be blinded to the intervention. Pre and post-exposure, various motor and functional outcome measures will be assessed and analyzed statistically.  The outcomes   will be compared between those with subacute stroke vs chronic stroke, age<40 years vs > 40 years and mild upper extremity impairment vs moderate to severe impairment. The study will also compare the outcomes in patients who receive 10 sessions of Armeospring and a subset of patients who receive 20 sessions of therapy using Armeospring. The perception of patients undergoing treatment with Armeospring will also be studied using the  Patient Global perception of change score. 

 
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