An Exploratory Study of a Wearable Robotic Hand Orthosis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Action Research Arm Test (ARAT) Score [Срок оценки: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)]

Вторичные конечные точки (7)

• Fugl-Meyer Motor Assessment (FMA) scale [Срок оценки: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)]
• Grip Strength (kg) [Срок оценки: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)]
• Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale) [Срок оценки: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)]
• EQ-5D-5L scale [Срок оценки: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)]
• Self-efficacy outcomes by UPSET (upper limb self-efficacy test) [Срок оценки: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)]
• System Usability Scale (SUS) [Срок оценки: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)]
• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) [Срок оценки: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Публикации

• Tanczak N, Plunkett TK, Lin S, Kuenzler L, Lau M, Kuah WKC, Ng CY, Gassert R, Chua K, Lambercy O. Feasibility of post-stroke hand rehabilitation supported by a soft robotic hand orthosis in-clinic and at-home. J Neuroeng Rehabil. 2025 Aug 21;22(1):183. doi: 10.1186/s12984-025-01717-6. PMID 40842028

Идентификаторы

NCT: NCT06412237 · DSRB2023/00448

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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