- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568951
Impact of Force Control of Hip Abductor Muscles in Healthy Adults and Individuals With Parkinson's Disease
Impact of Force Control of Hip Abductor Muscles on Postural Control in Middle-aged and Older Adults and Individuals With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Both aging and Parkinson's disease (PD) negatively affect postural control and increase the risk of falls, with frontal plane balance being particularly challenging for these populations. Previous studies have mainly focused on sagittal plane balance and have identified the important roles of ankle plantar flexors and knee extensors; however, the contribution of hip abductor muscles-key muscles for frontal plane stability-remains unclear, particularly in terms of their force production and control abilities. Therefore, this study aims to investigate hip abductor muscle force production and force control, and to examine whether these factors are associated with postural control, gait, and balance performance in individuals across different ages and those with PD. Healthy young, middle-aged, and older adults will be recruited from the community, and individuals with PD will be recruited from the Department of Neurology. Healthy participants must be in good health, able to walk independently, demonstrate normal cognitive function, and provide informed consent, while those with neurological, cardiovascular, musculoskeletal, or other conditions affecting motor performance will be excluded. For individuals with PD, inclusion criteria will be a clinical diagnosis of idiopathic PD, Hoehn and Yahr stages 1 to 3, stable anti-PD medication use, and the ability to follow instructions and walk at least 10 m. Exclusion criteria will include psychiatric, immune, integumentary, or musculoskeletal disorders, neurological conditions other than PD, lower extremity pain, uncontrolled cardiovascular disease, or inability to provide informed consent. All participants will undergo a one-time assessment, including maximal voluntary isometric contraction, force steadiness, postural control, and gait performance.
Surface electromyography will be used to assess neuromuscular function, postural control will be evaluated using a force plate under multiple standing conditions, and gait parameters will be measured at both comfortable and fast walking speeds. Statistical analyses will be conducted using ANOVA to examine group differences.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chu-Ling Yen
- Phone Number: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
Study Locations
-
-
-
Taoyuan, Taiwan
- Recruiting
- Chang Gung Memorial Hospital
-
Contact:
- Chu-Ling Yen
- Phone Number: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
-
Taoyuan, Taiwan
- Recruiting
- Chang Gung University
-
Contact:
- Chu-Ling Yen
- Phone Number: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Healthy people
Inclusion Criteria:
- 20 to 39 years (young), 40 to 59 years (young), and 60-85 years (old)
- generally in good health
- able to walk 10 m independently
- able to follow all instructions
Exclusion Criteria:
- neurologic, psychiatric, immune, integumentary, and musculoskeletal diseases or disorders which might influence this study
- any pain over the lower extremities
- uncontrolled cardiovascular diseases
- unable to provide informed consent.
PD
Inclusion Criteria:
- clinical diagnosis of idiopathic PD
- Hoehn and Yahr stages 1 to 3
- stable anti-PD medications
- able to walk 10 m independently
- able to follow all instructions
Exclusion Criteria:
- psychiatric, immune, integumentary, and musculoskeletal diseases or disorders which might influence this study
- neurological conditions other than PD
- any pain over the lower extremities
- uncontrolled cardiovascular diseases
- unable to provide informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy people
General healthy adults
|
We compare the young, middle-aged, and old groups
We compare the healthy group and PD group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal force
Time Frame: Baseline
|
The maximal force of lower extremity muscles
|
Baseline
|
|
Rate of torque development
Time Frame: Baseline
|
The ability to rapidly generate muscle force
|
Baseline
|
|
Force steadiness
Time Frame: Baseline
|
The ability to maintain a constant force output during a submaximal contraction
|
Baseline
|
|
Walking speed
Time Frame: Baseline
|
The time taken by participants to walk a standardized distance
|
Baseline
|
|
Step Length
Time Frame: Baseline
|
The linear distance between the two ankles, typically expressed in centimeter(cm).
|
Baseline
|
|
Cadence
Time Frame: Baseline
|
The number of steps taken per minute (SPM)
|
Baseline
|
|
Single Support Time
Time Frame: Baseline
|
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.
|
Baseline
|
|
Double Support Time
Time Frame: Baseline
|
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
|
Baseline
|
|
Swing Time
Time Frame: Baseline
|
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step.
It is usually expressed as a percentage of the total gait cycle or in seconds.
|
Baseline
|
|
Timed Up-and-Go Test
Time Frame: Baseline
|
Tthe time an individual takes to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
|
Baseline
|
|
Four Square Step Test
Time Frame: Baseline
|
Participants will be required to perform four square step test by changing directions while stepping forward, sideway, and backward over a low obstacle as fast as possible.
|
Baseline
|
|
Center of Pressure (COP) Velocity in Balance Tasks
Time Frame: Baseline
|
The speed at which the COP moves, calculated over the duration of the balance task.
Higher velocities may reflect more dynamic balance adjustments or instability.
Unit:millimeter per second(mm/s)
|
Baseline
|
|
Center of Pressure (COP) Area in Balance Tasks
Time Frame: Baseline
|
The area covered by the COP trajectory during the balance task, providing an estimate of the sway envelope.
A larger area might indicate poorer balance control.
Unit:square millimeter(mm^2)
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chu-Ling Yen, Chang Gung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Physiological Phenomena
- Behavioral Disciplines and Activities
- Psychological Tests
- Growth and Development
- Neuropsychological Tests
- Mental Status and Dementia Tests
- Aging
Other Study ID Numbers
- 202202289A3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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