Clinical trial NCT04463888: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation, Tenodesis, Stroke, Internet of Things
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the result of Box and blocks test
timeFrame: baseline, 4 weeks, 16 weeks and 20 weeks
Secondary outcomes:
measure: Change in the result of Fugl-Meyer assessment for UE motor function
timeFrame: baseline, 4 weeks, 16 weeks and 20 weeks
measure: Change in the result of Modified Ashworth scale (MAS)
timeFrame: baseline, 4 weeks,16 weeks and 20 weeks
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: baseline, 4 weeks,16 weeks and 20 weeks
measure: Change in the result of Motor Activity Log
timeFrame: baseline, 4 weeks,16 weeks and 20 weeks
measure: Clinical global impression scale
timeFrame: post-intervention (week 4)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: