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

Tan Tock Seng Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Device: H-Man Robot; Device: MyoPanda; Device: ReHandyBot

Study type: Interventional

Funder types: Other

Identifiers

NCT06406569

DSRB 2023/00527

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Functional impairment of the upper limb due to other pathologies

2. 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)

3. Anticipated life expectancy of less than 6 months

4. Pacemakers and other active implants

5. Active seizures within 3 months

6. 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

7. Cognitive impairment precluding study participation

8. Severe visual impairment or visual neglect affecting ability to use technologies

9. History of dementia, depression or behavioural problems

10. Pregnant or lactating females will not be allowed to participate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Home Robotics Upper Limb Training

Other group

Description:

The patients will first familiarize in the clinic with the 3 devices (H-MAN, ReHandyBot and MyoPanda) with initial assistance of the therapists and then take the devices home for independent, self-administered training under caregiver supervision. During the 6 weeks training (home phase), patients will be provided with two devices at any one time: with only the MyoPanda being used by the patient for 6 weeks. The H-MAN and ReHandyBot will stay with the patient for 3 weeks (i.e., 21 days) each.

Treatment:

Device: ReHandyBot

Device: MyoPanda

Device: H-Man Robot