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

Completed

• Conditions: Stroke

• Registration Number: NCT05212181
• Lead Sponsor: Tan Tock Seng Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-27
• Study Start: 2022-02-10
• Primary Completion: 2022-11-10
• Study Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Motor Assessment	Assessed at week 5 from baseline (week 0)	Change in Fugl Meyer Motor Assessment score in the affected arm

Secondary Outcome Measures

Name	Time	Method
Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)	Assessed at weeks 0, 5, 12 and 24	Measured by Digital Dynamometer (mean of 3 readings will be recorded)
Self-efficacy outcomes by UPSET (upper limb self-efficacy test)	Assessed at weeks 0, 5, 12 and 24	Questionnaire to measure self-efficacy in various tasks after stroke
HrQOL scales using SS-QOL (Stroke specific Quality of Life scale)	Assessed at weeks 0, 5, 12 and 24	Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function
PROMs using subjective scales (Likert 0-5) to questions	Assessed at weeks 0, 5, 12 and 24	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.
Streamlined Wolf-motor function test (SWMFT)	Assessed at weeks 0, 5, 12 and 24	Functional score for stroke patients, minimum 0, maximum 75; with higher score indicating better function
Aggregated number	Assessed at weeks 0, 5, 12 and 24	Mean/day and total cumulative over 30 days H-Man robot recorded arm repetitions (robotic metrics)
Action Research Arm Test (ARAT)	Assessed at weeks 0, 5, 12 and 24	Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore