Clinical trial NCT06270459: Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke
Official title: Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke (TRUST): a Study of Multi-cluster Adoption
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: Singapore General Hospital
First posted: 2024-02-21
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a multi-site prospective clinical trial, with single-arm study design with independent assessment of outcome measures (i.e., robotic metrics, standardized outcomes, quality of life, subjective measures).
Primary purpose: TREATMENT

Brief summary: There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.

In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors.

Detailed description: Current models of care in public healthcare institutions (PHI) cannot provide daily or frequent access to RAT without increasing burden and expenditure in direct healthcare resources. Shifting from the existing hospital-based model of care towards a home-centered model based deploying portable RAT, would ensure that patients can continue to receive intensive therapy after discharge and during the chronic phase of stroke.

More recently, RAT deploying table-top, portable, less complex, upper limb end effectors enable clinic-to-home transitions may offer decentralized therapy, minimally supervised by therapists as a potential means to bridge various gaps in access to RAT such as scheduling, physical or social barriers, distances and hospital lockdowns related to viral pandemics.

This study aims to explore the utilization, feasibility and acceptability using a multi-cluster deployment and adoption of a decentralised robot-aided telerehabilitation (RATR) clinical programme supported by AI-enabled platform, with remote monitoring by clinic therapists

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 post stroke.
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, 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. Hemianesthesia of affected limb.
7. History of dementia, severe depression, agitation, or behavioural problems.
8. Pregnancy or lactation in females
9. Absence of reliable carer to provide supervision during home training

Primary outcomes:
measure: Compliance Rates
timeFrame: Through study's data collection period, up to 2 years
Secondary outcomes:
measure: Fugl Meyer Motor Assessment (FMA)
timeFrame: Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)
measure: Action Research Arm Test (ARAT)
timeFrame: Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)
measure: Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)
timeFrame: Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)
measure: System Usability Scale (SUS)
timeFrame: Week 6 (end of HMAN @ Home)
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Week 6 (end of HMAN @ Home)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Karen Chua
role: PRINCIPAL_INVESTIGATOR
References: