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CompletedNCT05212181Updated Sep 21, 2023

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

An observational study in Stroke, sponsored by Tan Tock Seng Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Tan Tock Seng Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
12
Ages
21 Years to 90 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 12 is below the median of 160 across 1,692 observational studies indexed under Stroke.

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Lead sponsor

Tan Tock Seng Hospital is the lead sponsor of 103 studies on the registry; 17 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in outpatient clinics

Inclusion criteria

  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

Exclusion criteria

Exclusion Criteria:

  1. Non-stroke related causes of arm motor impairment
  2. 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.
  3. Anticipated life expectancy of \< 6 months
  4. 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.

(6) 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.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • DeviceH-Man

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

06

What researchers measure

Primary outcomes

  1. Fugl Meyer Motor Assessment

    Change in Fugl Meyer Motor Assessment score in the affected arm

    Time frame: Assessed at week 5 from baseline (week 0)

Secondary outcomes

  1. Aggregated number

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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: Assessed at weeks 0, 5, 12 and 24

07

Study locations

1 site
  • Tan Tock Seng Hospital
    Singapore, 308433, Singapore
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05212181
Lead sponsor
Tan Tock Seng Hospital
Collaborators
ARTICARES Pte Ltd
Responsible party
Sponsor
First posted
Jan 27, 2022
Start date
Feb 10, 2022
Primary completion
Nov 10, 2022
Completion
Dec 31, 2022
Last update
Sep 21, 2023

Study contacts

Dr Poo Lee Ong, MBBS
principal investigator · Tan Tock Seng Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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