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Not yet recruitingNCT07904624R@HUpdated Nov 2, 2026

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

An interventional study of ART in Brain Injuries, sponsored by National University Hospital, Singapore. Not yet recruiting at 3 sites in Singapore. Open to participants aged 16 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Health services research

Updated Nov 2, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
16 Years to 90 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Brain Injuries

Keywords

  • stroke
  • brain injury (traumatic/acquired)
  • spinal cord injury
03

In context

Brain Injuries

2,127 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 48 across 1,343 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 453 studies on the registry; 98 are open to participants now.

Browse National University Hospital, Singapore studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

(I) 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
  • 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

(II) 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

Exclusion criteria

Exclusion Criteria:

(I) 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.
  • 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

(II) 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • No intervention
    Control

    no interventions, only baseline and follow-up outcome measures will be done.

  • Active comparator
    Single ART

    Participants will use allocated ART device at home for 4 weeks after onboarding and consent.

    Device: ART

  • Active comparator
    Combined ART

    Participants 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.

    Device: ART

Interventions

  • DeviceART

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

06

What researchers measure

Primary outcomes

  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)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

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

  5. Device specific metrics (Single ART)

    e.g. HMAN: number of repetitions

    Time frame: A2 (week 6; +/- 1 week)

  6. Device specific metrics (Combined ART)

    e.g. HMAN: number of repetitions

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

  7. Dropout rates (Single ART)

    Dropout rates of the groups

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

  8. Dropout rates (Combined ART and control)

    Dropout rates of the groups

    Time frame: 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.

    Time frame: 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.

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

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

    Time frame: 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)

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

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: No — According to institution research policies, research agreement must be signed before sharing data with external parties.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2029, 35 months later.

Of 570 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 35 months is close to that.

Counting every sponsor, half of 603 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 29, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Oct 30, 2029
CompletionEst.
Oct 30, 2029
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
2 description edited
What changed in the outcomes
  • DescriptionAdherence to Home ART (Combined ART): how it is measured was reworded
  • DescriptionAdherence to Home ART (single ART): how it is measured was reworded
Nov 2, 2026
Registered
First appeared on the registry
Oct 29, 2026
Show all 2 updates
  1. Nov 2, 2026
    Primary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionAdherence to Home ART (Combined ART): how it is measured was reworded
    • DescriptionAdherence to Home ART (single ART): how it is measured was reworded
  2. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904624
Lead sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital, Alexandra Hospital
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Oct 30, 2029 (estimated)
Completion
Oct 30, 2029 (estimated)
Last update
Nov 2, 2026

Study contacts

Jia Min Yen, MBBS
Contact
jia_min_yen@nuhs.edu.sg
+65 6908 2222
Lian Ting Wong, BSC
Contact
lian_ting_wong@nuhs.edu.sg
Jia Min Yen, MBBS
principal investigator · National University Hospital, Singapore

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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