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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: H-Man

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in outpatient clinics

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: ARTICARES Pte Ltd
• Investigators: Principal Investigator: Dr Poo Lee Ong, MBBS, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DSRB 2021/00156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No