An Exploratory Study of a Wearable Robotic Hand Orthosis
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorTan Tock Seng Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
RELab tenoexo
DeviceThe RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RELab tenoexoExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Action Research Arm Test (ARAT) Score
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.
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)Secondary outcomes
1
Fugl-Meyer Motor Assessment (FMA) scale
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)2
Grip Strength (kg)
Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)3
Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)4
EQ-5D-5L scale
Standardized measure of health-related quality of life using a 5 level scale (no problem, slight problems, moderate problems, severe problems, unable to)
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)Other outcomes
1
Modified Ashworth Scale (MAS)
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.
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)2
Visual Analogue Scale (self-reported pain score)
Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.
Time frame
Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)Sponsors and contacts
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Source ClinicalTrials.gov