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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01971528
Other study ID # 100-3167A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2012
Est. completion date May 10, 2015

Study information

Verified date March 2024
Source Chang Gung University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research 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 and developing an effective training program for individuals with PD are very important. Fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Quantifying the weighting of central versus peripheral factors contributing to the fatigue in people with PD is important. Most of the conventional strength and endurance training programs were based on the researches of young groups. Almost no training program was design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation is very important for individuals with PD who prone to fatigue. Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. Combining afferent input with strength training was more effective than strength training along. ES, which is easy to quantify the dose of afferent input, is a feasible method to provide such training. The purpose of this project is to investigate the effects of the combination of ES at sensory threshold and strength training on voluntary activation in the individuals with PD.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date May 10, 2015
Est. primary completion date September 11, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Health subjects: Exclusion Criteria: - Musculoskeletal injuries for knee. - Osteoporosis. - Diabetes. PD subjects: Inclusion Criteria: - Clinical diagnosis of Parkinson disease. Exclusion Criteria: - Musculoskeletal injuries for knee. - Osteoporosis. - Diabetes. - Any peripheral or central nervous system injury or disease patients.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electronic muscle stimulator
Participants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week).
Other:
Muscle strength training
Participants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities.

Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle twitch force Measure of changes in muscle twitch force by interpolation twitch technique. baseline, 8 weeks.
Primary Muscle voluntary activity level Measure of changes in muscle voluntary activity level by interpolation twitch technique. Baseline,8 weeks
Primary Muscle strength test for lower extremities. Measure of changes in muscle strength test by clinical test. Baseline, 8 weeks
Primary The central activation and the excitability of motor cortex Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation. Baseline,8 weeks
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