| 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
|
|
|
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
|
|
|
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 |
|
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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. |