Establishing the Central and Peripheral Fatigue Indexes and VR Based Anti-fatigue Training Paradigm for Individuals With Parkinson Disease

March 28, 2024 updated by: Ya-Ju Chang, Chang Gung University

Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past researches indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue, building reliable fatigue indexes, and developing an effective training program for individuals with PD are very important.

The purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with PD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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
      • Taoyuan, Taiwan, 333
        • Chang Gung University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Clinical diagnosis of Parkinson disease
  • Hoehn and Yahr ≦3

Exclusion Criteria:

  • Musculoskeletal injuries
  • Osteoporosis
  • Diabetes
  • Any peripheral or central nervous system injury or disease patients

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Stage 1: Health group
To establish non-invasive fatigue monitoring method via testing healthy individuals.
Experimental: Stage 2: PD group
To find the optimal feedback variables for anti-fatigue training on individuals with PD.
Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)
To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.
Experimental: Stage 2: Health group
Stage 2 controlled group
Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)
To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.
Experimental: Stage 3: PD group
To evaluate the effect of four weeks of VR anti-fatigue ergo cycling training on various fatigue components and functional abilities in individuals with PD.
Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)
To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.
No Intervention: Stage 3: PD controlled group
Stage 3 controlled group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle twitch force
Time Frame: baseline, 1 week
Measure of changes in muscle twitch force by interpolation twitch technique.
baseline, 1 week
Muscle voluntary activity level
Time Frame: Baseline,1 week
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Baseline,1 week
Heart rate/Heart rate variability
Time Frame: Baseline,1 week
Measure of changes in Heart rate/Heart rate variability.
Baseline,1 week
Borg's rate of perceived exertion
Time Frame: Baseline,1 week
Measure of changes in Borg's rate of perceived exertion.
Baseline,1 week

Collaborators and Investigators

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

Sponsor

Chang Gung University

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)

December 10, 2014

Primary Completion (Actual)

July 30, 2015

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimated)

December 23, 2013

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-5141B

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.

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