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StrokeNCT05212181

Clinic to Home Robotics-assisted Telerehabilitation for Upper Limb (CHISEL)

An observational study of Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hemiparetic weakness is common after stroke and only a small group of patients achieve useful upper limb function despite best rehabilitation efforts. This is due to the lack of intensive upper limb therapies to drive neuroplasticity either in clinic or at home. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Stroke
What is being tested?
H-Man
Type of treatment
Medical device
How many people
12 participants
Where
1 siteSingapore
Study dates
10 Feb 2022to 31 Dec 2022
Phase
Observational
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

Study population: Patients in outpatient clinics

Who may be able to join

  • 1) Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging (2) Age 21 to 90 years, both males and females (3) At least > 28 days (4) Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60 (5) Has a stable home abode and a carer/ NOK to supervise home based exercise. (6) Ability to sit supported continuously for 60 minutes (7) Montreal Cognitive Assessment (MOCA) score > 21/30 (8) 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, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers.
  • Anticipated life expectancy of < 6 months
  • Inability to tolerate sitting continuously for 60 minutes (5 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.
  • Hemi anaesthesia of affected limb (7) Severe visual impairment or visual neglect affecting ability to use H-Man robot (8) History of dementia, severe depression or behavioural problems (9) Pregnant or lactating females will not be allowed to participate (10) Absence of reliable carer to provide supervision during home training.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

Official title: Smart Robot Therapy for Stroke Upper Limb Rehabilitation: A Proof-of-value Trial of Clinic to Home Robotics-assisted Telerehabilitation

Hemiparetic weakness is common after stroke and only a small group of patients achieve useful upper limb function despite best rehabilitation efforts. This is due to the lack of intensive upper limb therapies to drive neuroplasticity either in clinic or at home.

In this study, we plan to pilot home-based, robot-aided-therapy using H-man to deliver intensive arm rehabilitation.

Read the detailed description

It has been assumed that stroke survivors reach a plateau in their recovery within 3-6 months of their stroke. They tend to receive minimal rehabilitation support once they are discharged to the community citing obstacles such as ambulation, transportation, and cost.

H-man is a novel telerehabilitation, upper limb training robot, that will deliver robot-aided therapy in patients' homes by clinic-based therapists through remote monitoring and under the supervision of their caregivers.

The study aims to refine and evaluate the feasibility, efficacy and safety of home-based training using the H-man robot.

Conditions
Stroke
Being tested
H-Man
Medical subject headings
Stroke

What participants receive

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

  • H-ManDevice

    H-Man device will be deployed to patients for onboarding and home-based training.

What is being measured

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

  1. Fugl Meyer Motor Assessment

    Change in Fugl Meyer Motor Assessment score in the affected arm

    Measured: Assessed at week 5 from baseline (week 0)

Secondary outcomes (7)

  1. Aggregated number

    Mean/day and total cumulative over 30 days H-Man robot recorded arm repetitions (robotic metrics)

    Measured: Assessed at weeks 0, 5, 12 and 24

  2. Streamlined Wolf-motor function test (SWMFT)

    Functional score for stroke patients, minimum 0, maximum 75; with higher score indicating better function

    Measured: Assessed at weeks 0, 5, 12 and 24

  3. Action Research Arm Test (ARAT)

    Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function

    Measured: Assessed at weeks 0, 5, 12 and 24

  4. 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: Assessed at weeks 0, 5, 12 and 24

  5. Self-efficacy outcomes by UPSET (upper limb self-efficacy test)

    Questionnaire to measure self-efficacy in various tasks after stroke

    Measured: Assessed at weeks 0, 5, 12 and 24

  6. HrQOL scales using SS-QOL (Stroke specific Quality of Life scale)

    Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function

    Measured: Assessed at weeks 0, 5, 12 and 24

  7. PROMs using subjective scales (Likert 0-5) to questions

    E.g. how beneficial, how comfortable, how useful, how easy was H-Man robot training experience at home, and would they prefer this to be part of standard therapy.

    Measured: Assessed at weeks 0, 5, 12 and 24

Timeline

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

  1. First posted27 Jan 2022
  2. Study start10 Feb 2022
  3. Primary completion10 Nov 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212181
Sponsor's protocol ID
DSRB 2021/00156
Status last verified
Sep 2023
First submitted
18 Jan 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aguirre-Ollinger G, Chua KSG, Ong PL, Kuah CWK, Plunkett TK, Ng CY, Khin LW, Goh KH, Chong WB, Low JAM, Mushtaq M, Samkharadze T, Kager S, Cheng HJ, Hussain A. Telerehabilitation using a 2-D planar arm rehabilitation robot for hemiparetic stroke: a feasibility study of clinic-to-home exergaming therapy. J Neuroeng Rehabil. 2024 Nov 26;21(1):207. doi: 10.1186/s12984-024-01496-6.

    PubMed 39593101

Questions about this trial

What is this clinical trial studying?

An observational study of 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 1 inclusion and 5 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 21 Sep 2023. 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?

Fugl Meyer Motor Assessment (time frame: Assessed at week 5 from baseline (week 0)). 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 NCT05212181, 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 21 Sep 2023.

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