StrokeTRUSTNCT06270459
Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke
A study testing HMAN Robot in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- HMAN Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2024to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- History of dementia, severe depression, agitation, or behavioural problems.
- Pregnancy or lactation in females
- Absence of reliable carer to provide supervision during home training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke (TRUST): a Study of Multi-cluster Adoption
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.
Read the 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
- Conditions
- Stroke
- Being tested
- HMAN Robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMAN RobotDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HMAN Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance Rates
Using cloud data from vendor, time (min/hours) of HMAN robot usage
Measured: Through study's data collection period, up to 2 years
Secondary outcomes (5)
Fugl Meyer Motor Assessment (FMA)
Change in Fugl Meyer Motor Assessment score in the affected arm
Measured: 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)
Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function
Measured: 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)
Measured by Digital Dynamometer (mean of 3 readings will be recorded)
Measured: 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)
For evaluation of the HMAN robot's perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Measured: Week 6 (end of HMAN @ Home)
Intrinsic Motivation Inventory (IMI)
To assess participants' subjective experience on usage of the HMAN robot using 4 separate subscales (Interest/Enjoyment, Perceived competence, Perceived choice, Pressure/Tension)
Measured: Week 6 (end of HMAN @ Home)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Nov 2024
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Chua, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270459
- Sponsor's protocol ID
- DSRB 2023/00954
- Acronym
- TRUST
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. eCollection 2026.
PubMed 42256580
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke (TRUST): a Study of Multi-cluster Adoption
- ClinicalTrials.gov ID
- NCT06270459
- Acronym / sponsor ID
- TRUST / DSRB 2023/00954
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Singapore General Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| HMAN robot @ Home | Experimental | Device: HMAN Robot4 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMAN RobotThe 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. | Device | HMAN robot @ Home |
Primary outcome
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
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 42256580Shankar 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. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Chua principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMAN Robot in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance Rates (time frame: Through study's data collection period, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.