Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: HMAN Robot

• Registration Number: NCT06270459
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.

In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors.

Detailed Description

Current models of care in public healthcare institutions (PHI) cannot provide daily or frequent access to RAT without increasing burden and expenditure in direct healthcare resources. Shifting from the existing hospital-based model of care towards a home-centered model based deploying portable RAT, would ensure that patients can continue to receive intensive therapy after discharge and during the chronic phase of stroke.

More recently, RAT deploying table-top, portable, less complex, upper limb end effectors enable clinic-to-home transitions may offer decentralized therapy, minimally supervised by therapists as a potential means to bridge various gaps in access to RAT such as scheduling, physical or social barriers, distances and hospital lockdowns related to viral pandemics.

This study aims to explore the utilization, feasibility and acceptability using a multi-cluster deployment and adoption of a decentralised robot-aided telerehabilitation (RATR) clinical programme supported by AI-enabled platform, with remote monitoring by clinic therapists

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Study Start: 2024-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-08-14
• Study Completion: 2025-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HMAN robot @ Home	HMAN Robot	4 weeks of daily HMAN robot training at participant's home (for up to 120 minutes per day with rest breaks) interspersed with 2 sessions of conventional therapy sessions (COTS) and 2 additional COTS upon completion of 4-week HMAN robot training at home.

Primary Outcome Measures

Name	Time	Method
Compliance Rates	Through study's data collection period, up to 2 years	Using cloud data from vendor, time (min/hours) of HMAN robot usage

Secondary Outcome Measures

Name	Time	Method
Fugl Meyer Motor Assessment (FMA)	Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)	Change in Fugl Meyer Motor Assessment score in the affected arm
Action Research Arm Test (ARAT)	Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)	Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function
System Usability Scale (SUS)	Week 6 (end of HMAN @ Home)	For evaluation of the HMAN robot's perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)	Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)	Measured by Digital Dynamometer (mean of 3 readings will be recorded)
Intrinsic Motivation Inventory (IMI)	Week 6 (end of HMAN @ Home)	To assess participants' subjective experience on usage of the HMAN robot using 4 separate subscales (Interest/Enjoyment, Perceived competence, Perceived choice, Pressure/Tension)

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore