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NCT Number: NCT06412237

An Exploratory Study of a Wearable Robotic Hand Orthosis

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore

Location status: Recruiting

Location contact

Megan Lau

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RELab tenoexo

Device

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

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function

  2. Grip Strength (kg)

    Time frame: 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

  3. 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)

    Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.

  4. EQ-5D-5L scale

    Time frame: 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)

  5. 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)

    Questionnaire to measure self-efficacy in various tasks after stroke

  6. System Usability Scale (SUS)

    Time frame: 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)

  7. 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)

    To evaluate user satisfaction with assistive technology, scaled from 1 (Not satisfied at all) to 5 (Very satisfied)

Other outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

    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.

  2. 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)

    Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Lau

CONTACT

[email protected]

68894580

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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