Clinical trial NCT05212181: Clinic to Home Robotics-assisted Telerehabilitation for Upper Limb (CHISEL)
Official title: Smart Robot Therapy for Stroke Upper Limb Rehabilitation: A Proof-of-value Trial of Clinic to Home Robotics-assisted Telerehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: ARTICARES Pte Ltd
First posted: 2022-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in outpatient clinics

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl Meyer Motor Assessment
timeFrame: Assessed at week 5 from baseline (week 0)
Secondary outcomes:
measure: Aggregated number
timeFrame: Assessed at weeks 0, 5, 12 and 24
measure: Streamlined Wolf-motor function test (SWMFT)
timeFrame: Assessed at weeks 0, 5, 12 and 24
measure: Action Research Arm Test (ARAT)
timeFrame: Assessed at weeks 0, 5, 12 and 24
measure: Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)
timeFrame: Assessed at weeks 0, 5, 12 and 24
measure: Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
timeFrame: Assessed at weeks 0, 5, 12 and 24
measure: HrQOL scales using SS-QOL (Stroke specific Quality of Life scale)
timeFrame: Assessed at weeks 0, 5, 12 and 24
measure: PROMs using subjective scales (Likert 0-5) to questions
timeFrame: Assessed at weeks 0, 5, 12 and 24
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Dr Poo Lee Ong, MBBS
role: PRINCIPAL_INVESTIGATOR
References: