Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke

NCT06270459 | Recruiting

• 1 other identifier: DSRB 2023/00954
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Compliance Rates

  Using cloud data from vendor, time (min/hours) of HMAN robot usage

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

Secondary Outcomes (5)

• 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)

• 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)

• 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)

• System Usability Scale (SUS)

  Week 6 (end of HMAN @ Home)

• Intrinsic Motivation Inventory (IMI)

  Week 6 (end of HMAN @ Home)

Study Arms (1)

HMAN robot @ Home

EXPERIMENTAL

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.

Device: HMAN Robot

Interventions

HMAN 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.

HMAN robot @ Home

Eligibility Criteria

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

You may not qualify if:

• Non-stroke related causes of arm motor impairment.
• 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.
• Anticipated life expectancy of \< 6 months.
• Inability to tolerate sitting continuously for 60 minutes.
• 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.
• Hemianesthesia of affected limb.
• History of dementia, severe depression, agitation, or behavioural problems.
• Pregnancy or lactation in females
• Absence of reliable carer to provide supervision during home training

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• National University Hospital, Singapore: collaborator
• Singapore General Hospital: collaborator

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

• Karen Chua

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Low Ai Mei Jaclyn

CONTACT

68894580; Jaclyn_AM_LOW@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 is a multi-site prospective clinical trial, with single-arm study design with independent assessment of outcome measures (i.e., robotic metrics, standardized outcomes, quality of life, subjective measures).

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: November 1, 2024
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)