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

Stroke Clinical Trial

— Home RehabGym  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406569
• Other study ID #: DSRB 2023/00527
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Tan Tock Seng Hospital
• Contact: Low Ai Mei Jaclyn
• Phone: 68894580
• Email: Jaclyn_AM_LOW[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Secondary	Action Research Arm Test (ARAT)	Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function	Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Secondary	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)	Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment))
Secondary	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.	Weeks 0 (baseline), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Secondary	Box and Block Test (BBT)	Measures unilateral gross manual dexterity.	Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)