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

NCT ID: NCT06406569

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-01-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home Robotics Upper Limb Training

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.

Group Type: OTHER

H-Man Robot

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuah Wee Keong Christopher

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Megan Lau Si En

Role: CONTACT

Megan_SE_Lau@ttsh.com.sg

68894580

Facility Contacts

Megan Lau

Role: primary

Megan_SE_Lau@ttsh.com.sg

Other Identifiers

DSRB 2023/00527

Identifier Type: -

Identifier Source: org_study_id