A Smart Home-based Exoskeleton Robot System for Stroke Patients
Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 24, 2023
March 1, 2023
2.4 years
July 6, 2020
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
baseline, 4 weeks, 16 weeks and 20 weeks
Secondary Outcomes (5)
Change in the result of Fugl-Meyer assessment for UE motor function
baseline, 4 weeks, 16 weeks and 20 weeks
Change in the result of Modified Ashworth scale (MAS)
baseline, 4 weeks,16 weeks and 20 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
baseline, 4 weeks,16 weeks and 20 weeks
Change in the result of Motor Activity Log
baseline, 4 weeks,16 weeks and 20 weeks
Clinical global impression scale
post-intervention (week 4)
Study Arms (2)
Robot training with Smart Home-based Exoskeleton Robot System
EXPERIMENTALIn 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 .
control group
ACTIVE COMPARATORIn 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 .
Interventions
occupational therapy targeted to goals that are relevant to the functional needs of the patient
Eligibility Criteria
You may qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
Related Publications (1)
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.
PMID: 36122608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2020
First Posted
July 9, 2020
Study Start
August 19, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 24, 2023
Record last verified: 2023-03