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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212181
• Other study ID #: DSRB 2021/00156
• Status: Completed
• Start date: February 10, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	ARTICARES Pte Ltd

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Motor Assessment	Change in Fugl Meyer Motor Assessment score in the affected arm	Assessed at week 5 from baseline (week 0)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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