Clinical trial NCT06412237: An Exploratory Study of a Wearable Robotic Hand Orthosis
Official title: An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Hand exoskeleton robot
Robotic hand orthosis
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single site, pilot, feasibility study that focuses on the transition of technology use from the clinic to home environment.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Action Research Arm Test (ARAT) Score
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary outcomes:
measure: Fugl-Meyer Motor Assessment (FMA) scale
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
measure: Grip Strength (kg)
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
measure: Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
measure: EQ-5D-5L scale
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
measure: Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
measure: System Usability Scale (SUS)
timeFrame: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
Other outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
measure: Visual Analogue Scale (self-reported pain score)
timeFrame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Tegan Plunkett
role: PRINCIPAL_INVESTIGATOR
References: