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

NCT06406569 | Recruiting

• 1 other identifier: DSRB 2023/00527
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Technology-aided; Upper limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• Compliance Rates

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

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

Secondary Outcomes (5)

• Fugl Meyer Motor Assessment (FMA)

  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)

  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)

  Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment))

• Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)

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

• Box and Block Test (BBT)

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

Study Arms (1)

Home Robotics Upper Limb Training

OTHER

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.

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

Interventions

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.

Home Robotics Upper Limb Training

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.

Home Robotics Upper Limb Training

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.

Home Robotics Upper Limb Training

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kuah Wee Keong Christopher

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lau Si En

CONTACT

68894580; Megan_SE_Lau@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a pilot, clinical feasibility, assessor-blinded trial to evaluate the feasibility of Home RehabGym concept through deployment of three rehabilitation devices at patients' homes: MyoPanda, H-Man and ReHandyBot. During the 6 weeks training at 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 and then alternate.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: July 31, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)