A Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke

Официальное название

Home RehabGym: a Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke

Обзор

Due to limited resources such as the low therapist to patient ratio or high costs associated to rehabilitation therapy, providing higher therapy dose to patients after discharge is highly challenging. This often results in non-use of the impaired limb as a result of the decreased therapy dose, causing partial loss of the functional improvements previously gained during early rehabilitation. In this study, the investigators plan to pilot the HomeRehab Gym concept via the deployment of three rehabilitation devices at patients' homes: MyoPanda, H-Man and ReHandyBot.

Подробное описание

Previous research has proven that technology-aided upper limb rehabilitation is non-inferior in terms of feasibility and efficacy when compared to conventional therapy in stroke patients. These rehabilitation devices can be set up as a 'rehabilitation gym' (RehabGym), where patients can interact with several devices that target different body and rehabilitation domains and, thus allows for a holistic and complementary therapy.

Despite recent studies having shown that training with a RehabGym under reduced supervision in a hospital is not only feasible but also equally beneficial in terms of clinical outcomes, however, a RehabGym has never been set up at a patient's home to the best of our knowledge.

This study aims to investigate the feasibility and safety of a RehabGym at home concept using three different upper-limb technologies (H-Man, ReHandyBot, MyoPanda) that are established, clinically tested and allow for on-demand therapy. Objective measures of clinical efficacy will also be examined, and cost-analysis to determine the economic feasibility of a commercial implementation of RehabGym at home in the future will be performed.

Вмешательства

• Устройство H-Man Robot
  The HMAN is certified as a CE class 2A upper limb rehabilitation robot suitable for hospital, clinic and home-based use in 2020 by Health Sciences Authority, Singapore. It has since been employed in post-stroke neurorehabilitation therapy and assessment of sensorimotor functions in stroke patients.
• Устройство ReHandyBot
  ReHandyBot is the portable version of ReHapticKnob a robot developed at ETH Zurich that provides neurocognitive therapy, focusing on hand opening and closing movements as well as prono-supination of the forearm.
• Устройство MyoPanda
  MyoPanda is a passive wrist/hand device which patients use to train the hand and wrist function by controlling a virtual avatar with EMG activity measures.

Первичные конечные точки

• Compliance Rates [Срок оценки: Through study's data collection period, up to 2 years.]

Вторичные конечные точки (5)

• Fugl Meyer Motor Assessment (FMA) [Срок оценки: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)]
• Action Research Arm Test (ARAT) [Срок оценки: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)]
• System Usability Scale (SUS) [Срок оценки: Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment))]
• Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale) [Срок оценки: Weeks 0 (baseline), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)]
• Box and Block Test (BBT) [Срок оценки: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)]

Критерии участия

Критерии включения

• Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging
• Age 21 to 80 years, both males and females
• At least 28 days post-stroke
• Upper limb motor impairment of Fugl-Meyer Assessment (FMA) scale 20 to 50
• Montreal Cognitive Assessment (MoCA) > 21/30
• Ability to sit supported and continuously for 60 minutes
• Stable home abode with enough space to place technologies
• Has a carer/next of kin to supervise home-based exercises

Критерии исключения

• Functional impairment of the upper limb due to other pathologies
• Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers)
• Anticipated life expectancy of less than 6 months
• Pacemakers and other active implants
• Active seizures within 3 months
• Local factors potentially worsened by intensive technology-aided upper-limb therapy and computer-based training:

• Spasticity - modified Ashworth Scale MAS > 2 of any upper limb muscle groups
• Severe pain in affected arm - Visual Analogue Scale for pain VAS > 5/10
• Skin wounds
• Cognitive impairment precluding study participation
• Severe visual impairment or visual neglect affecting ability to use technologies
• History of dementia, depression or behavioural problems
• Pregnant or lactating females will not be allowed to participate

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

Идентификаторы

NCT: NCT06406569 · DSRB 2023/00527

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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