A Smart Home-based Exoskeleton Robot System for Stroke Patients

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04463888
Collaborator
(none)
44
1
2
28.4
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: occupational therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients
Actual Study Start Date :
Aug 19, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in the result of Box and blocks test [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.

Secondary Outcome Measures

  1. Change in the result of Fugl-Meyer assessment for UE motor function [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.

  2. Change in the result of Modified Ashworth scale (MAS) [baseline, 4 weeks,16 weeks and 20 weeks]

    Muscle tone is defined by the resistance of a muscle being stretched without resistance.

  3. Change in the result of Semmes-Weinstein monofilament (SWM) test [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.

  4. Change in the result of Motor Activity Log [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.

  5. Clinical global impression scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng-Kung University Hospital Tainan Taiwan 704

Sponsors and Collaborators

  • National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT04463888
Other Study ID Numbers:
  • B-BR-107-084
First Posted:
Jul 9, 2020
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022