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Recruiting NCT06270459

Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HMAN Robot.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 21 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Device HMAN Robot
    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 outcome measures

  • Compliance Rates [Time frame: Through study's data collection period, up to 2 years]
Secondary outcome measures (5)
  • 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)]
  • 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)]
  • 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)]
  • System Usability Scale (SUS) [Time frame: Week 6 (end of HMAN @ Home)]
  • Intrinsic Motivation Inventory (IMI) [Time frame: Week 6 (end of HMAN @ Home)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • Tan Tock Seng Hospital — Singapore

Publications

  • Shankar R, Choo SX, Chen Z, Kuah CWK, Plunkett TK, Ng CY, Lin S, Goh KH, Yee E, Ge X, Zhang D, Chong WB, Low JAM, Lau MSE, Lim XY, Naing SY, Wong LT, Noronha B, Aguirre-Ollinger G, Hussain A, Ong PL, Chua KSG. Telerehabilitation robotics for upper limb rehabilitation after stroke (TRUST): a multi-site pragmatic trial protocol. Front Neurol. 2026 May 21;17:1775829. doi: 10.3389/fneur.2026.1775829. PMID 42256580

Identifiers

NCT: NCT06270459 · DSRB 2023/00954

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗