A Smart Home-based Exoskeleton Robot System for Stroke Patients

March 22, 2023 updated by: National Cheng-Kung University Hospital

Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 .
Other: occupational therapy
occupational therapy targeted to goals that are relevant to the functional needs of the patient
Active Comparator: 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 .
Other: occupational therapy
occupational therapy targeted to goals that are relevant to the functional needs of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 4 weeks, 16 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 4 weeks, 16 weeks and 20 weeks
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.
baseline, 4 weeks,16 weeks and 20 weeks
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.
baseline, 4 weeks,16 weeks and 20 weeks
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.
baseline, 4 weeks,16 weeks and 20 weeks
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.
post-intervention (week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-107-084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rehabilitation, Tenodesis, Stroke, Internet of Things

Clinical Trials on occupational therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe