Back to results

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

Primary Purpose

Parkinson's Disease (PD)

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Virtual Reality anti-fatigue ergo cycling training (Self-made)

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring Fatigue, electromyography (EMG), central fatigue, cycling training

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Chang Gung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Stage 1: Health group

Stage 2: PD group

Stage 2: Health group

Stage 3: PD group

Stage 3: PD controlled group

Arm Description

To establish non-invasive fatigue monitoring method via testing healthy individuals.

To find the optimal feedback variables for anti-fatigue training on individuals with PD.

Stage 2 controlled 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.

Stage 3 controlled group

Outcomes

Primary Outcome Measures

Muscle twitch force

Measure of changes in muscle twitch force by interpolation twitch technique.

Muscle voluntary activity level

Measure of changes in muscle voluntary activity level by interpolation twitch technique.

Heart rate/Heart rate variability

Measure of changes in Heart rate/Heart rate variability.

Borg's rate of perceived exertion

Measure of changes in Borg's rate of perceived exertion.

Secondary Outcome Measures

Full Information

NCT ID

NCT02017938

First Posted

December 17, 2013

Last Updated

December 17, 2013

Sponsor

Chang Gung University

1. Study Identification

Unique Protocol Identification Number

NCT02017938

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease (PD)

Keywords

Fatigue, electromyography (EMG), central fatigue, cycling training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stage 1: Health group

Arm Type

No Intervention

Arm Description

To establish non-invasive fatigue monitoring method via testing healthy individuals.

Arm Title

Stage 2: PD group

Arm Type

Experimental

Arm Description

To find the optimal feedback variables for anti-fatigue training on individuals with PD.

Arm Title

Stage 2: Health group

Arm Type

Experimental

Arm Description

Stage 2 controlled group

Arm Title

Stage 3: PD group

Arm Type

Experimental

Arm Description

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.

Arm Title

Stage 3: PD controlled group

Arm Type

No Intervention

Arm Description

Stage 3 controlled group

Intervention Type

Procedure

Intervention Name(s)

Virtual Reality anti-fatigue ergo cycling training (Self-made)

Intervention Description

To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.

Primary Outcome Measure Information:

Title

Muscle twitch force

Description

Measure of changes in muscle twitch force by interpolation twitch technique.

Time Frame

baseline, 1 week

Title

Muscle voluntary activity level

Description

Measure of changes in muscle voluntary activity level by interpolation twitch technique.

Time Frame

Baseline,1 week

Title

Heart rate/Heart rate variability

Description

Measure of changes in Heart rate/Heart rate variability.

Time Frame

Baseline,1 week

Title

Borg's rate of perceived exertion

Description

Measure of changes in Borg's rate of perceived exertion.

Time Frame

Baseline,1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Chang Gung University

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ya-Ju Chang, PhD

Phone

88632118800

Ext

5515

yjchang@mail.cgu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs