- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07723027
Effects of Whole Body Vibration Versus Proprioceptive Neuromuscular Facilitation Pattern With Rhythmic Based Training on Clinical Outcomes in Patients With Parkinson's Disease.
20. Juli 2026 aktualisiert von: Lahore University of Biological and Applied Sciences
This study has important clinical, academic, and practical relevance in neuromuscular rehabilitation.
Clinically, it aims to identify effective and tolerable rehabilitation strategies for individuals with Parkinson's disease by comparing whole-body vibration therapy with proprioceptive neuromuscular facilitation (PNF) patterns combined with rhythmic-based training, thereby supporting evidence-based physiotherapy practice and improving patient adherence.
Academically, it contributes to the limited literature on comparative effectiveness of these interventions and incorporates patient-centered outcomes such as exercise perception, which are often underreported.
From a practical and societal perspective, identifying a more acceptable and effective approach may enhance long-term participation in rehabilitation, potentially slow disease progression, improve quality of life, and reduce the overall healthcare burden associated with Parkinson's disease.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Parkinson's disease is a progressive neurodegenerative disorder characterized by the loss of dopaminergic neurons in the substantia nigra, leading to motor symptoms such as tremor, rigidity, bradykinesia, and postural instability.
It also presents with non-motor symptoms including cognitive decline, autonomic dysfunction, and reduced quality of life.
The title of the present study focuses on evaluating the effectiveness of a combined rehabilitation approach integrating rhythmic-based training, whole-body vibration, and proprioceptive neuromuscular facilitation to improve gait, balance, and functional mobility in individuals with Parkinson's disease.
The proposed protocols involve structured rhythmic auditory cueing exercises to enhance movement coordination and timing, whole-body vibration sessions aimed at improving neuromuscular activation and muscle strength, and proprioceptive neuromuscular facilitation techniques to facilitate motor control, flexibility, and functional movement patterns; these interventions are delivered in a progressive manner, tailored to patient tolerance and disease severity, with close monitoring to ensure safety and adherence.
The study design is a randomized clinical trial with two experimental groups.
The study duration is expected to span 8 to 12 weeks, allowing sufficient time for neuromuscular adaptations and observable functional improvements while maintaining feasibility and participant compliance.
Outcome measures include standardized and validated tools such as the Unified Parkinson's Disease Rating Scale for assessing disease severity, the Timed Up and Go test for functional mobility, the 10-Meter Walk Test for gait speed, the Mini-BESTest for dynamic balance, and quality of life scales to evaluate overall patient well-being; these measures are recorded at baseline and post-intervention to determine the effectiveness of the combined rehabilitation protocol, providing comprehensive insight into motor performance, balance control, and functional independence in individuals with Parkinson's disease.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
42
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Punjab Province
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Shakargarh, Punjab Province, Pakistan, 51580
- THQ Shakargarh
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Age between 40 and 60 years.
- Patients of both genders (male and female).
- Parkinson's disease severity at Hoehn and Yahr (H&Y) stage 2 and 3.
- Ability to walk independently for 6 minutes without an assistive device.
- Score greater than 40 on the Berg Balance Scale.
Exclusion Criteria:
- Presence of impaired Cognition.
- Significant Orthopedic and Musculoskeletal conditions that limit the adherence to exercise and WBV requirements.
- Other medical conditions like thrombosis, cardiovascular conditions and medical implants that are contradicted for WBV.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Whole Body Vibration with Rhythmic Based Training
Whole Body Vibration (WBV) and Rhythm-Based Training (RBT) are adjunct therapeutic interventions used to enhance functional mobility, balance, and motor coordination.
WBV provides mechanical oscillatory stimuli to the body through a vibration platform, aiming to improve neuromuscular activation and postural control.
RBT utilizes external auditory cues to guide movement timing, promoting auditory-motor entrainment and improving movement coordination and gait performance.
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WBV will be applied during standing exercises using a vibration platform set at a frequency of 11 Hz and an amplitude of 3-6 mm (vertical oscillation).
The intervention will be administered in intermittent cycles of 1 minute of vibration followed by 1 minute of rest, with a total cumulative exposure of 10-14 minutes per session (5-7 bouts).
Concurrently, RBT will be delivered using an auditory metronome providing rhythmic cues synchronized with the exercise movements, with the tempo maintained between 110-130 beats per minute (BPM) to facilitate timing, coordination, and motor performance.
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Experimental: Proprioceptive Neuromuscular Facilitation Pattern with Rhythmic Based Training
Proprioceptive Neuromuscular Facilitation (PNF) Rhythmic Initiation (RI) D1 patterns combined with Rhythm-Based Training (RBT) are used to facilitate motor learning, improve movement initiation, and enhance neuromuscular coordination.
The D1 flexion and extension patterns of PNF target coordinated multi-planar upper and lower limb movements, progressing through passive, active-assisted, and active-resistive phases to improve motor control, normalize muscle tone, and increase movement efficiency.
RBT provides external auditory cueing to enhance timing and rhythmic synchronization of voluntary movement.
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The patient will perform PNF Rhythmic Initiation (RI) D1 flexion and extension patterns for both upper and lower extremities in standing.
The D1 flexion pattern involves shoulder extension, abduction, and external rotation progressing to flexion, adduction, and internal rotation, while the D1 extension pattern represents the reverse movement.
The exercise will be progressed from passive to active-assisted and then to active-resistive movements to facilitate motor control and movement initiation.
In addition, Rhythm-Based Training (RBT) will be applied using an auditory metronome to provide rhythmic cues synchronized with the active phase of the PNF movements, particularly during transitions between flexion and extension, with a consistent tempo of 110-130 beats per minute (BPM).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Timed Up and Go (TUG) Test
Zeitfenster: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The Timed Up and Go (TUG) test is a simple functional mobility assessment that measures the time taken (in seconds) to stand from a chair, walk 3 meters, turn, walk back, and sit down.
It evaluates balance, gait, and functional mobility in a single task.
Lower scores indicate better performance, with <10 seconds considered normal, 10-20 seconds indicating mostly independent mobility, and >20 seconds suggesting functional limitation.
It is also commonly used as an indicator of fall risk, especially in neurological populations such as Parkinson's disease.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)
Zeitfenster: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The Unified Parkinson's Disease Rating Scale (UPDRS-III) is a clinician-administered tool used to evaluate motor impairment in Parkinson's disease.
It assesses key motor domains including tremor, rigidity, bradykinesia, posture, gait, and postural stability through direct observation.
Each item is scored on a 0-4 scale, where 0 represents normal function and 4 indicates severe impairment, with a maximum total score of 132.
Higher scores reflect greater motor dysfunction.
The scale is widely used for monitoring disease severity and progression in both clinical and research settings.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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Mini-Balance Evaluation Systems Test (Mini-BESTest)
Zeitfenster: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The Mini-BESTest is a clinical balance assessment designed to evaluate dynamic balance and postural control across multiple systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and gait stability.
It consists of 14 items scored from 0 to 2, with a total score ranging from 0 to 28, where higher scores indicate better balance performance.
It is particularly sensitive in detecting balance impairments and fall risk in individuals with neurological conditions such as Parkinson's disease.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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10-Meter Walk Test (10MWT)
Zeitfenster: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The 10-Meter Walk Test (10MWT) is a standardized measure of gait speed, where the time taken to walk a central 10-meter distance is recorded and converted into meters per second (m/s).
It assesses functional walking ability and mobility performance.
The test can be performed at a comfortable or fast pace to evaluate functional capacity.
It is widely used in Parkinson's disease to monitor gait impairments and response to rehabilitation, as gait speed is a strong indicator of overall functional status.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2026
Primärer Abschluss (Tatsächlich)
9. Juli 2026
Studienabschluss (Tatsächlich)
9. Juli 2026
Studienanmeldedaten
Zuerst eingereicht
20. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Juli 2026
Zuerst gepostet (Tatsächlich)
23. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UBAS/ERB/26/04/038
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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