An Exploratory Study of a Wearable Robotic Hand Orthosis

Stroke Clinical Trial

Official title:

An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412237
• Other study ID #: DSRB2023/00448
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Tan Tock Seng Hospital
• Contact: Megan Lau
• Phone: 68894580
• Email: megan_se_lau[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• RELab tenoexo
The RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Other	Visual Analogue Scale (self-reported pain score)	Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Primary	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.	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary	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	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary	Grip Strength (kg)	Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary	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.	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary	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)	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary	Self-efficacy outcomes by UPSET (upper limb self-efficacy test)	Questionnaire to measure self-efficacy in various tasks after stroke	Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary	System Usability Scale (SUS)	To assess the overall usability of the tenoexo (effectiveness, efficiency, satisfaction), scaled from 1 (Strongly disagree) to 5 (Strongly Agree)	Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
Secondary	Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)	To evaluate user satisfaction with assistive technology, scaled from 1 (Not satisfied at all) to 5 (Very satisfied)	Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)