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Completed

NCT Number: NCT04463888

A Smart Home-based Exoskeleton Robot System for Stroke Patients

In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of therapeutic activity with clinicians' guidance is often short of number in therapy sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the data they generate that are a new trend of rehabilitation strategy for providing remote home-programs support. The specific aim of this study is to to explore the feasibility of introducing the rental services of a Smart Home-based Exoskeleton Robot System through the IoT business model. And the second purpose is to investigate the effects of applying the exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic stroke patients.The expected outcomes of this research are to clarify the feasibility of using IoT business model for launching smart rehabilitation device rental service and the effects of application a high dosage of hand movement training as home program on motor and hand function for patients with chronic stroke.

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Key information

Conditions

Rehabilitation, Tenodesis, Stroke, Internet of Things Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2) computed tomography scan that excluded pathologies other than unilateral cerebral hemisphere injury, (3) capacity to perform a pinch task with the thumb and index finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory, perceptual, praxis, and memory, as determined using Lowenstein occupational therapy cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke.

Exclusion criteria

  • not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading to difficulty of following instruction.

Treatment and study plan

Occupational Therapy

Other

occupational therapy targeted to goals that are relevant to the functional needs of the patient

Primary outcomes

  1. Change in the result of Box and blocks test

    Time frame: baseline, 4 weeks, 16 weeks and 20 weeks

    The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.

Secondary outcomes

  1. Change in the result of Fugl-Meyer assessment for UE motor function

    Time frame: baseline, 4 weeks, 16 weeks and 20 weeks

    Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.

  2. Change in the result of Modified Ashworth scale (MAS)

    Time frame: baseline, 4 weeks,16 weeks and 20 weeks

    Muscle tone is defined by the resistance of a muscle being stretched without resistance.

  3. Change in the result of Semmes-Weinstein monofilament (SWM) test

    Time frame: baseline, 4 weeks,16 weeks and 20 weeks

    The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

  4. Change in the result of Motor Activity Log

    Time frame: baseline, 4 weeks,16 weeks and 20 weeks

    MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.

  5. Clinical global impression scale

    Time frame: post-intervention (week 4)

    Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2020
Registry last updated
Mar 24, 2023

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

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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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