An Exploratory Study of a Wearable Robotic Hand Orthosis
- Conditions
- Stroke
- Interventions
- Device: RELab tenoexo
- Registration Number
- NCT06412237
- Lead Sponsor
- Tan Tock Seng Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RELab tenoexo 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.
- Primary Outcome Measures
Name Time Method Action Research Arm Test (ARAT) Score Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment) 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.
- Secondary Outcome Measures
Name Time Method Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale) Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment) Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.
EQ-5D-5L scale Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment) Standardized measure of health-related quality of life using a 5 level scale (no problem, slight problems, moderate problems, severe problems, unable to)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training) To evaluate user satisfaction with assistive technology, scaled from 1 (Not satisfied at all) to 5 (Very satisfied)
Grip Strength (kg) Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment) Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
Fugl-Meyer Motor Assessment (FMA) scale Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment) Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Self-efficacy outcomes by UPSET (upper limb self-efficacy test) Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment) Questionnaire to measure self-efficacy in various tasks after stroke
System Usability Scale (SUS) Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training) To assess the overall usability of the tenoexo (effectiveness, efficiency, satisfaction), scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Trial Locations
- Locations (1)
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore