A Smart Home-based Exoskeleton Robot System for Stroke Patients

NCT ID: NCT04463888

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation, Tenodesis, Stroke, Internet of Things

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robot training with Smart Home-based Exoskeleton Robot System

In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based robot assisted tenodesis-grip training per day, 5 days a week, for 4 weeks .

Group Type EXPERIMENTAL

occupational therapy

Intervention Type OTHER

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

control group

In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based specific motor task training per day, 5 days a week, for 4 weeks .

Group Type ACTIVE_COMPARATOR

occupational therapy

Intervention Type OTHER

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

Interventions

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occupational therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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Kuo LC, Yang KC, Lin YC, Lin YC, Yeh CH, Su FC, Hsu HY. Internet of Things (IoT) Enables Robot-Assisted Therapy as a Home Program for Training Upper Limb Functions in Chronic Stroke: A Randomized Control Crossover Study. Arch Phys Med Rehabil. 2023 Mar;104(3):363-371. doi: 10.1016/j.apmr.2022.08.976. Epub 2022 Sep 16.

Reference Type DERIVED
PMID: 36122608 (View on PubMed)

Other Identifiers

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B-BR-107-084

Identifier Type: -

Identifier Source: org_study_id

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