Using robots for upper limb rehabilitation after stroke

Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke (TRUST): a Study of Multi-cluster Adoption

This study is testing if using a portable robot to help stroke survivors do upper limb exercises at home can improve their recovery and make therapy more accessible after leaving the hospital.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 21 Years to 90 Years
• Sex: All
• Sponsor: Tan Tock Seng Hospital (other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT06270459 on ClinicalTrials.gov

What this trial studies

This study aims to improve rehabilitation for stroke survivors by utilizing portable robot-aided telerehabilitation (RATR) systems that allow patients to receive therapy at home. The approach focuses on addressing the gap in therapy frequency after hospital discharge, where patients often experience a decline in motor function due to reduced access to intensive therapy. By deploying AI-enabled platforms for remote monitoring, the study seeks to evaluate the feasibility and acceptability of this decentralized rehabilitation model. Participants will engage in supervised exercises using the HMAN Robot to enhance their upper limb motor skills.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 to 90 who are at least 28 days post-stroke and have upper limb motor impairments.

Not a fit: Patients with non-stroke related motor impairments or those with severe uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the recovery and quality of life for stroke survivors by providing continuous access to rehabilitation therapy.

How similar studies have performed: Other studies have shown promise in using robotic-assisted rehabilitation, indicating potential for success with this approach.

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 90 years, both males and females.
3. At least \> 28 days post stroke.
4. Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60
5. Has a stable home abode and a carer/ NOK to supervise home based exercise.
6. Ability to sit supported continuously for 60 minutes.
7. Montreal Cognitive Assessment (MOCA) score \> 21/30
8. Able to understand purpose of research and give consent.

Exclusion Criteria:

1. Non-stroke related causes of arm motor impairment.
2. Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, end stage renal/liver/heart/lung failure, unresolved cancers.
3. Anticipated life expectancy of \< 6 months.
4. Inability to tolerate sitting continuously for 60 minutes.
5. Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of Modified Ashworth Scale grades \>2 skin wounds, shoulder, arm pain VAS \> 5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures.
6. Hemianesthesia of affected limb.
7. History of dementia, severe depression, agitation, or behavioural problems.
8. Pregnancy or lactation in females
9. Absence of reliable carer to provide supervision during home training

Where this trial is running

Singapore, Singapore

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

Study contacts

• Principal investigator: Karen Chua — Tan Tock Seng Hospital
• Study coordinator: Low Ai Mei Jaclyn

Conditions: Stroke