- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06412237
An Exploratory Study of a Wearable Robotic Hand Orthosis
An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available.
In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.
Study Overview
Detailed Description
Assistive technologies have shown promising results in immediate improvement in functional abilities.
RELab tenoexo is a fully wearable and portable robotic hand orthoses (RHO) used for functional training. Its design support end users with functional hand opening and closing and can be applied in therapy exercises or during functional activities. While prior research demonstrated its effectiveness for spinal cord injury, it hasn't been tailored for multi-ethnic stroke populations.
This study aims to determine the feasibility and extent to which the RELab tenoexo can complement therapy training in clinic and further be used as both a training and assistive device in the home environment. In addition, it also aims to investigate the amount of upper limb usage before, during and after the training period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: May Kyi Thet Mon
- Phone Number: 68894580
- Email: May_Kyi_Thet_Mon@TTSH.Com.sg
Study Locations
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Singapore, Singapore
- Tan Tock Seng Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
- Post stroke of at least 6 months with stable neurological status.
- Age 21 to 80 years of age.
- Hemiplegic pattern and shoulder abduction MRC motor power > 2/5 and elbow extension >2/5
- Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
- MOCA > or equal to 22/30
- Able to give and sign informed consent at research site.
- Able to speak English
Exclusion Criteria:
- Non-stroke related causes of arm motor impairment.
- Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder.
- Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale >5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
- Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
- Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale > 5).
- Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
- Have a pacemaker. Magnets are used throughout the system.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: RELab tenoexo
3 weeks in clinic training (9 training sessions, two clinical assessment and 2 usability evaluations) followed by 2 weeks home training (1-hour daily training and to the extent participants desire).
Lastly 1-month follow up clinical assessment and IMU data collection.
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The RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Action Research Arm Test (ARAT) Score
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Motor Assessment (FMA) scale
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Grip Strength (kg)
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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EQ-5D-5L scale
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Standardized measure of health-related quality of life using a 5 level scale (no problem, slight problems, moderate problems, severe problems, unable to)
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Questionnaire to measure self-efficacy in various tasks after stroke
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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System Usability Scale (SUS)
Time Frame: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
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To assess the overall usability of the tenoexo (effectiveness, efficiency, satisfaction), scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
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Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
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Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time Frame: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
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To evaluate user satisfaction with assistive technology, scaled from 1 (Not satisfied at all) to 5 (Very satisfied)
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Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth Scale (MAS)
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Measures the level of spasticity at the elbow and finger flexors of proximal interphalangeal joint regions; scored from "0 to 4" with "4" indicating affected part is more spastic in flexion/extension.
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Visual Analogue Scale (self-reported pain score)
Time Frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.
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Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tegan Plunkett, Tan Tock Seng Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRB2023/00448
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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