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Completed

NCT Number: NCT05212181

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Non-stroke related causes of arm motor impairment
  • 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.
  • Anticipated life expectancy of < 6 months
  • 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.

Treatment and study plan

H-Man

Device

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

Primary outcomes

  1. Fugl Meyer Motor Assessment

    Time frame: Assessed at week 5 from baseline (week 0)

    Change in Fugl Meyer Motor Assessment score in the affected arm

Secondary outcomes

  1. Aggregated number

    Time frame: Assessed at weeks 0, 5, 12 and 24

    Mean/day and total cumulative over 30 days H-Man robot recorded arm repetitions (robotic metrics)

  2. Streamlined Wolf-motor function test (SWMFT)

    Time frame: Assessed at weeks 0, 5, 12 and 24

    Functional score for stroke patients, minimum 0, maximum 75; with higher score indicating better function

  3. Action Research Arm Test (ARAT)

    Time frame: 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

  4. Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)

    Time frame: Assessed at weeks 0, 5, 12 and 24

    Measured by Digital Dynamometer (mean of 3 readings will be recorded)

  5. Self-efficacy outcomes by UPSET (upper limb self-efficacy test)

    Time frame: Assessed at weeks 0, 5, 12 and 24

    Questionnaire to measure self-efficacy in various tasks after stroke

  6. HrQOL scales using SS-QOL (Stroke specific Quality of Life scale)

    Time frame: 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

  7. PROMs using subjective scales (Likert 0-5) to questions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • ARTICARES Pte Ltd

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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