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NCT Number: NCT06270459

Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore

Location status: Recruiting

Location contact

Low Jaclyn

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Compliance Rates

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

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

Secondary outcomes

  1. Fugl Meyer Motor Assessment (FMA)

    Time frame: 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

  2. Action Research Arm Test (ARAT)

    Time frame: 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

  3. Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)

    Time frame: 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)

  4. System Usability Scale (SUS)

    Time frame: Week 6 (end of HMAN @ Home)

    For evaluation of the HMAN robot's perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)

  5. Intrinsic Motivation Inventory (IMI)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Low Ai Mei Jaclyn

CONTACT

[email protected]

68894580

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • National University Hospital, Singapore
  • Singapore General Hospital

Registry information

Official study title

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

Acronym: TRUST

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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