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A Smart Home-based Exoskeleton Robot System for Stroke Patients

Primary Purpose

Rehabilitation, Tenodesis, Stroke, Internet of Things

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
occupational therapy
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation, Tenodesis, Stroke, Internet of Things

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cheng-Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot training with Smart Home-based Exoskeleton Robot System

control group

Arm Description

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 .

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the result of Fugl-Meyer assessment for UE motor function
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.
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched without resistance.
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Change in the result of Motor Activity Log
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.
Clinical global impression scale
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.

Full Information

First Posted
July 6, 2020
Last Updated
March 22, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04463888
Brief Title
A Smart Home-based Exoskeleton Robot System for Stroke Patients
Official Title
Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Tenodesis, Stroke, Internet of Things

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot training with Smart Home-based Exoskeleton Robot System
Arm Type
Experimental
Arm Description
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 .
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
occupational therapy
Intervention Description
occupational therapy targeted to goals that are relevant to the functional needs of the patient
Primary Outcome Measure Information:
Title
Change in the result of Box and blocks test
Description
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Time Frame
baseline, 4 weeks, 16 weeks and 20 weeks
Secondary Outcome Measure Information:
Title
Change in the result of Fugl-Meyer assessment for UE motor function
Description
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.
Time Frame
baseline, 4 weeks, 16 weeks and 20 weeks
Title
Change in the result of Modified Ashworth scale (MAS)
Description
Muscle tone is defined by the resistance of a muscle being stretched without resistance.
Time Frame
baseline, 4 weeks,16 weeks and 20 weeks
Title
Change in the result of Semmes-Weinstein monofilament (SWM) test
Description
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Time Frame
baseline, 4 weeks,16 weeks and 20 weeks
Title
Change in the result of Motor Activity Log
Description
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.
Time Frame
baseline, 4 weeks,16 weeks and 20 weeks
Title
Clinical global impression scale
Description
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.
Time Frame
post-intervention (week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

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A Smart Home-based Exoskeleton Robot System for Stroke Patients

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