- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Chu-Ling Yen
- Numero di telefono: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
Luoghi di studio
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Taoyuan, Taiwan
- Reclutamento
- Chang Gung Memorial Hospital
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Contatto:
- Chu-Ling Yen
- Numero di telefono: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
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Taoyuan, Taiwan
- Reclutamento
- Chang Gung University
-
Contatto:
- Chu-Ling Yen
- Numero di telefono: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Healthy people
General healthy adults
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We compare the young, middle-aged, and old groups
We compare the healthy group and PD group.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maximal force
Lasso di tempo: Baseline
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The maximal force of lower extremity muscles
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Baseline
|
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Rate of torque development
Lasso di tempo: Baseline
|
The ability to rapidly generate muscle force
|
Baseline
|
|
Force steadiness
Lasso di tempo: Baseline
|
The ability to maintain a constant force output during a submaximal contraction
|
Baseline
|
|
Walking speed
Lasso di tempo: Baseline
|
The time taken by participants to walk a standardized distance
|
Baseline
|
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Step Length
Lasso di tempo: Baseline
|
The linear distance between the two ankles, typically expressed in centimeter(cm).
|
Baseline
|
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Cadence
Lasso di tempo: Baseline
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The number of steps taken per minute (SPM)
|
Baseline
|
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Single Support Time
Lasso di tempo: 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
|
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Double Support Time
Lasso di tempo: 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
|
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Swing Time
Lasso di tempo: Baseline
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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
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Timed Up-and-Go Test
Lasso di tempo: Baseline
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Tthe time an individual takes to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
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Baseline
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Four Square Step Test
Lasso di tempo: 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
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Center of Pressure (COP) Velocity in Balance Tasks
Lasso di tempo: Baseline
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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)
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Baseline
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Center of Pressure (COP) Area in Balance Tasks
Lasso di tempo: Baseline
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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)
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Baseline
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Chu-Ling Yen, Chang Gung University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Sinucleinopatie
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie Neurodegenerative
- Disturbi del movimento
- Malattie parkinsoniane
- Malattie dei gangli basali
- Morbo di Parkinson
- Fenomeni fisiologici
- Discipline e attività comportamentali
- Test psicologici
- Crescita e sviluppo
- Test neuropsicologici
- Stato mentale e test di demenza
- Invecchiamento
Altri numeri di identificazione dello studio
- 202202289A3
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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