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| Name | Class |
|---|---|
| ARTICARES Pte Ltd | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-Man | Device | H-Man device will be deployed to patients for onboarding and home-based training. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Motor Assessment | Change in Fugl Meyer Motor Assessment score in the affected arm | Assessed at week 5 from baseline (week 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Aggregated number | Mean/day and total cumulative over 30 days H-Man robot recorded arm repetitions (robotic metrics) | Assessed at weeks 0, 5, 12 and 24 |
| Streamlined Wolf-motor function test (SWMFT) |
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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:
(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.
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Patients in outpatient clinics
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| Name | Affiliation | Role |
|---|---|---|
| Dr Poo Lee Ong, MBBS | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39593101 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Functional score for stroke patients, minimum 0, maximum 75; with higher score indicating better function
| Assessed at weeks 0, 5, 12 and 24 |
| Action Research Arm Test (ARAT) | Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function | Assessed at weeks 0, 5, 12 and 24 |
| 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) | Assessed at weeks 0, 5, 12 and 24 |
| Self-efficacy outcomes by UPSET (upper limb self-efficacy test) | Questionnaire to measure self-efficacy in various tasks after stroke | Assessed at weeks 0, 5, 12 and 24 |
| 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 | Assessed at weeks 0, 5, 12 and 24 |
| 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. | Assessed at weeks 0, 5, 12 and 24 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |