Home-based upper limb rehabilitation for stroke patients using advanced technology

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

This study is testing a new home-based rehab program with advanced devices to see if it helps stroke patients recover their arm movement better and more easily after leaving the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Tan Tock Seng Hospital (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT06406569 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and safety of a home-based rehabilitation gym concept for stroke patients, utilizing three advanced upper limb rehabilitation devices: MyoPanda, H-Man, and ReHandyBot. The aim is to provide patients with on-demand therapy in their homes, addressing the challenges of limited access to rehabilitation services post-discharge. The study will assess clinical efficacy through objective measures and conduct a cost-analysis to explore the economic viability of implementing this technology in home settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 80 who have experienced a stroke and have upper limb motor impairment.

Not a fit: Patients with functional impairments of the upper limb due to other conditions or those with severe uncontrolled medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for stroke patients by providing accessible and effective therapy at home.

How similar studies have performed: Previous studies have shown that technology-aided rehabilitation is effective, but this home-based approach is novel and has not been extensively tested.

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

Where this trial is running

Singapore, Singapore

• Tan Tock Seng Hospital — Singapore, Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Kuah Wee Keong Christopher — Tan Tock Seng Hospital
• Study coordinator: Megan Lau Si En

Conditions Stroke; Technology-aided; Upper limb rehabilitation