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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorTan Tock Seng Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • H-Man Robot

    Device

    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.

  • ReHandyBot

    Device

    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.

  • MyoPanda

    Device

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Home Robotics Upper Limb TrainingOther 3 interventions

Trial outcomes

Primary outcomes

1

Compliance Rates

Using cloud data from vendor, time (min/hours) of robot (H-Man, ReHandyBot, MyoPanda) usage

Time frame
Through study's data collection period, up to 2 years.

Secondary outcomes

1

Fugl Meyer Motor Assessment (FMA)

Change in Fugl Meyer Motor Assessment score in the affected arm, minimum 0, maximum 66, with higher scores indicating better function

Time frame
Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
2

Action Research Arm Test (ARAT)

Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function

Time frame
Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
3

System Usability Scale (SUS)

For evaluation of the different robots' (H-Man, ReHandyBot, MyoPanda) perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)

Time frame
Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment))
4

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
Weeks 0 (baseline), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)

Other outcomes

Sponsors and contacts

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