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Brain InjuriesR@HNCT07904624

Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)

A study testing ART in people with Brain Injuries, run by National University Hospital, Singapore at 3 sites in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To study the feasibility of the various model of ART rental service for home use, prescribed and supervised by experienced rehabilitation professionals and supported by tech partners, and its efficacy in improving function in neurological patients requiring high-intensity rehabilitation. Read more about this study

Who is it for?
Ages 16 to 90 years
Conditions the study is for
Brain Injuries
What is being tested?
ART
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
3 sitesSingapore
Study dates
1 Nov 2026to 30 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • Aged 16 years to 90 years. For participants age 16-20, an assent form will be used and the legally authorized representative (LAR) will be consented
  • >3 weeks from incident event
  • Diagnosis of as stroke, brain injury or SCI confirmed by neuroimaging and admitting specialists
  • Assessed by treating clinician to be able to understand and comply to programme requirements (e.g. safe use of ART and purpose)
  • Availability of suitable carer to ensure safety of participants during home ART training and follow up, if needed
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  • Suitable and stable home environment to allow for use of ART (minimum of 1.5m x1.5m space if robots or VR exergames used)*
  • Being able to follow instruction and give consent.
  • Home environment assessment by therapist may be needed to ensure appropriate training environment
  • ART-Specific Inclusion Criteria (using Oxford Medical Research Counicl MRC scale 0-5/5)
  • HMAN(arm): MRC grade ≥ 2/5 shoulder/elbow
  • ReHandyBot (hand): MRC grade ≥ 1/5 finger flexion or extension
  • Esoglove (hand): MRC grade ≥ 1/5 finger flexion or extension
  • EzyGain: either UE/LE MRC grade ≥3/5 (antigravity)
  • TrainFES (upper or lower limb): MRC grade <4, targeted impairments are not due to lower motor neuron lesions
  • ezyGain (VR): UL and LL MRC grade≥3/5 MRC grade (subject to clinician evaluation)
  • Transcranial direct current stimulation (tDCS): Sum of Medical Research Council grades for shoulder abduction and finger Extension (SAFE) ≤ 8, prescribed with functional training tasks during tDCS

Who cannot join

  • General Exclusion Criteria
  • Uncontrolled medical conditions (e.g., Unstable angina, untreated hypertension, sepsis/fever)
  • Sitting or orthostatic intolerance <30 minutes (unless device can be performed supine)
  • Presence of seizures within 6 months of screening or a history of epilepsy or anti-epileptic medications
  • End stage organ failure (e.g. renal failure, cardiac failure) on organ replacement therapy
  • Anticipated life expectancy < 6 months.
Show all 18Show fewer
  • Psychiatric conditions precluding safe use of ART
  • Pressure sores (decubitus ulcers) or wounds /poor skin conditions at point of contact with ART
  • Severe spasticity (spasticity Modified Ashworth Scale (MAS >2)
  • Presence of contractures, joint or limb limitations of range of movement to preclude safe and effective application of robotics/ FES (joint replacements allowed)
  • Significant pain (Visual Analogue Scale VAS>5/10) deemed to potentially worsen with ART
  • Unhealed /active fractures
  • Presence of known contact allergies to ART interfaces
  • Presence of lower motor neuron causes of weakness / myopathies /myositis
  • Pregnancy or Lactation status
  • ART-Specific Exclusion Criteria
  • TrainFES (upper or lower limb): Presence of pacemaker, defibrillator or other implanted metallic or electronic device.
  • tDCS: Presence of cranial surgery, cochlear implant, ventriculoperitoneal (VP) shunt

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jia Min Yen, MBBS contact

+65 6908 2222

jia_min_yen@nuhs.edu.sg

Lian Ting Wong, BSC contact

lian_ting_wong@nuhs.edu.sg

Singapore3 sites

  • National University Hospital

    Singapore, 119074

    Jia Min Yen, MBBS, +65 6908 2222, jia_min_yen@nuhs.edu.sg

    Lian Ting Wong, BSc, lian_ting_wong@nuhs.edu.sg

  • Alexandra Hospital

    Singapore, 159964

    Effie Chew, MBBS, +65 6472 2000

    Lian TIng Wong, BSc, lian_ting_wong@nuhs.edu.sg

  • Tan Tock Seng Hospital

    Singapore

    Karen Chua, MBBS, +65 6256 6011, karen.chua@nhghealth.com.sg

    Wei Binh Chong, wei.binh.chong@nhghealth.com.sg

Other trials in Singapore

About this study

Official title: Rehability@Home (R@H): A Large-scale Multi-centre Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)

To study the feasibility of the various model of ART rental service for home use, prescribed and supervised by experienced rehabilitation professionals and supported by tech partners, and its efficacy in improving function in neurological patients requiring high-intensity rehabilitation.

Read the detailed description

Over four years, the programme will:

  • Establish new care pathways and protocols that integrate clinical care, ART at home and patient interaction, supported by remote monitoring and information technology.
  • Deliver new, high-intensity therapy through a hybrid programme of tech-enabled rehabilitation at home combined with standard outpatient therapy services.
  • Develop an integrated digital platform that enables multi-centre remote monitoring, informs patient selection, personalised rehabilitation tech prescription and dosing, and supports patient outcome prediction, and
  • Evaluate the value of a home-based, ART rental model via collection and analysis of patient demand, health and rehabilitation outcomes, operational feasibility, and cost effectiveness.

Participants in the intervention group will use the ART device at home for

  • 4 weeks (single ART) or
  • 2 ART device at home for 4 weeks each (combined ART)

There will also be control group whereby the group will not recieve the ART intervention at home. Both intervention group and control group will be asked to complete questionnaires and assessments as well for a total of 4 assessment visits (single ART group; A1-A4) or 5 assessment visits (combined ART group and control; A1-A5).

Conditions
Brain Injuries
Being tested
ART
Keywords
stroke, brain injury (traumatic/acquired), spinal cord injury
Medical subject headings
Brain Injuries, Stroke, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARTDevice

    The prescription of ART will be clinically guided, and the ART will be used in participant's home.

Study groups in NCT07904624
Study groupRoleWhat they receive
ControlNo interventionno interventions, only baseline and follow-up outcome measures will be done.
Single ARTActive comparatorParticipants will use allocated ART device at home for 4 weeks after onboarding and consent.
Receives: Device: ART
Combined ARTActive comparatorParticipants will use the first allocated ART device at home for 4 weeks after onboarding and consent, and second ART device for another 4 weeks after first ART intervention of 4 weeks.
Receives: Device: ART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Outpatient rehabilitation dose (time) (single ART)

    Home ART duration metrics (duration/day/month, pattern date/time stamp, repetitions etc) (participant training log and extracted device metrics from ART) vs centre based therapy duration (single and combo ART only)

    Measured: A2 (week 6; +/- 1 week)

  2. Outpatient rehabilitation dose (time) (Combined ART)

    Home ART duration metrics (duration/day/month, pattern date/time stamp, repetitions etc) (participant training log and extracted device metrics from ART) vs centre based therapy duration (single and combo ART only)

    Measured: A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week)

  3. Adherence to Home ART (single ART)

    Home training compliancy. Participant percentage (%) compliancy for prescription of the relevant ART given to participants by the therapist.

    Measured: A2 (week 6; +/- 1 week)

  4. Adherence to Home ART (Combined ART)

    Home training compliancy. Participant percentage (%) compliancy for prescription of the relevant ART given to participants by the therapist.

    Measured: A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week)

  5. Device specific metrics (Single ART)

    e.g. HMAN: number of repetitions

    Measured: A2 (week 6; +/- 1 week)

  6. Device specific metrics (Combined ART)

    e.g. HMAN: number of repetitions

    Measured: A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week)

  7. Dropout rates (Single ART)

    Dropout rates of the groups

    Measured: A4 (week 24; +/- 1 week) or withdrawn date

  8. Dropout rates (Combined ART and control)

    Dropout rates of the groups

    Measured: A5 (1 year; +/- 1 week) or withdrawn date

  9. System usability scale (SUS) (0-100) (single ART)

    To quantify the usability of the ART. Higher scores mean a better outcome.

    Measured: A2 (week 6; +/- 1 week)

  10. System usability scale (SUS) (0-100) (Combined ART)

    To quantify the usability of the ART. Higher scores mean a better outcome.

    Measured: A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week)

Secondary outcomes (19)

  1. Baseline Demographics

    e.g. age, sex, race, ethnicity, language, Charlson Comorbidity Index (CCI), diagnosis, baseline function, past 3 months prior technology utilization, social determinants etc

    Measured: A1 (baseline; week 0-1)

  2. Fugl-Meyer Assessment (FMA) (0-66) (combined ART and control)

    For Upper limb (UL) Assessment of non-Spinal Cord Injury (SCI) patients (combined ART and control). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  3. Fugl-Meyer Assessment (FMA) (0-66) (single ART)

    For Upper limb (UL) Assessment of non-Spinal Cord Injury patients (single ART). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  4. Action Research Arm Test (ARAT) (0-57) (combined ART and control)

    For Upper limb (UL) Assessment of non-SCI patients (combined ART and control). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 month)

  5. Action Research Arm Test (ARAT) (0-57) (single ART)

    For Upper limb (UL) Assessment of non-SCI patients (single ART). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  6. Hand grip strength (HGS) (combined ART and control)

    For Upper limb (UL) Assessment of affected upper limb patients (combined ART and control). Average of 3 scores for both hands.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  7. Hand grip strength (HGS) (single ART)

    For Upper limb (UL) Assessment of affected upper limb patients (single ART). Average of 3 scores for both hands.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  8. Short Physical Performance Battery (SPPB) (0-12) (combined ART and control)

    For Lower Limb (UL) Assessment of affected lower limb patients (combined ART and control). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  9. Short Physical Performance Battery (SPPB) (0-12) (single ART)

    For Lower Limb (UL) Assessment of affected lower limb patients (single ART). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  10. 3 Minute Walk Test (3MWT) (combined ART and control)

    For Lower Limb (UL) Assessment of affected lower limb patients (combined ART and control)

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  11. 3 Minute Walk Test (3MWT) (single ART)

    For Lower Limb (UL) Assessment of affected lower limb patients (single ART)

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  12. Walking Index for Spinal Cord Injury II (WISCI) (0-20) (combined ART and control)

    For Assessment of SCI patients (combined ART and control). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  13. Walking Index for Spinal Cord Injury II (WISCI) (0-20) (single ART)

    For Assessment of SCI patients (single ART). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  14. ASIA Impairment Scale (ASIA) (0-112) (combined ART and control)

    For Assessment of SCI patients (combined ART and control). Excluding VAC, DAP and sensory). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  15. ASIA Impairment Scale (ASIA) (0-112) (single ART)

    For Assessment of SCI patients (single ART). Excluding VAC, DAP and sensory). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

  16. Modified Barthel Index (MBI) (0-100) (combined ART and control)

    Shah et al. modifications to the original Barthel Index that assesses functional disability based on 10 activities of daily life (ADLs) (combined ART and control). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week)

  17. Modified Barthel Index (MBI) (0-100) (single ART)

    Shah et al. modifications to the original Barthel Index that assesses functional disability based on 10 activities of daily life (ADLs) (single ART). Higher scores mean a better outcome.

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week)

  18. Quality of Life Scale EQ-5D-5L (combined ART and control)

    EuroQOL. Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.(combined ART and control)

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 10; +/- 1 week), A4 (week 24; +/- 1 week), A5 (week 52; +/- 1 week)

  19. Quality of Life Scale EQ-5D-5L (single ART)

    EuroQOL. Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. (single ART)

    Measured: A1 (baseline; week 0-1), A2 (week 6; +/- 1 week), A3 (week 24; +/- 1 week), A4 (week 52; +/- 1 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion30 Oct 2029 (estimated)

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants are assigned to either control, single ART or combined ART group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904624
Sponsor's protocol ID
2026-0370
Acronym
R@H
Status last verified
May 2026
First submitted
15 Oct 2026
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to institution research policies, research agreement must be signed before sharing data with external parties.

Questions about this trial

What is this clinical trial studying?

A study testing ART in people with Brain Injuries, run by National University Hospital, Singapore at 3 sites 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 17 inclusion and 18 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jia Min Yen, MBBS (+65 6908 2222, jia_min_yen@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outpatient rehabilitation dose (time) (single ART) (time frame: A2 (week 6; +/- 1 week)). The study lists 10 primary outcomes in all. 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 NCT07904624.

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 Nov 2026.

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