Home-Based Exercise Programs for Fall Prevention in Parkinson Disease
15. Mai 2026 aktualisiert von: Selim Mahmut GÜNAY, Uludag University
Effectiveness of Fall-Preventive Home Exercise Programs in Patients With Parkinson Disease: A Randomized Controlled Trial
Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population.
This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks.
Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Selim GÜNAY, Asst Prof
- Telefonnummer: +90 539 462 8521
- E-Mail: mgselim1@gmail.com
Studienorte
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Antakya
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Hatay, Antakya, Türkei (türkiye)
- Rekrutierung
- Hatay Mustafa Kemal University
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Kontakt:
- Selim Mahmut Günay
- Telefonnummer: +905394628521
- E-Mail: mgselim1@gmail.com
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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
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Diagnosis of Parkinson disease confirmed by a neurologist
- Hoehn and Yahr stage 3 or 4 Parkinson disease
- Diagnosis of Parkinson disease for at least 5 years
- Willingness to participate in the study and provide written informed consent
- Ability to walk independently or with minimal assistance
- Mini-Mental State Examination score >24
Exclusion Criteria:
- Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease
- Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy
- History of serious fall-related injury or surgery within the last 6 months
- Any additional health condition that would prevent participation in the exercise program during the study period
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: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Otago Home Exercise Program
Participants in this arm will receive the Otago Home Exercise Program.
The program includes home-based strengthening, static balance, and dynamic balance exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes.
Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
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nce exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes.
Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The program will be reviewed and progressed at week 3.
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Aktiver Komparator: Structured Home Exercise Program
Participants in this arm will receive a structured home exercise program.
The program includes spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles.
Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
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The structured home exercise program is a home-based exercise intervention including spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles.
Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The program will be reviewed and progressed at week 3.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Falls Efficacy Scale
Zeitfenster: Baseline, week 3, and week 6
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Fall-related self-efficacy and fear of falling will be assessed using the Falls Efficacy Scale.
The scale evaluates the participant's confidence in performing daily activities without falling.
Scores range from 10 to 100, with lower scores indicating greater fear of falling and higher scores indicating lower fear of falling.
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Baseline, week 3, and week 6
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gait Speed
Zeitfenster: Baseline, week 3, and week 6
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Gait speed will be assessed using video-based kinematic analysis with Kinovea software.
Walking speed will be calculated in meters per second from recorded walking trials.
Higher gait speed indicates better walking performance.
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Baseline, week 3, and week 6
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Timed Up and Go Test
Zeitfenster: Baseline, week 3, and week 6
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r, walk a short distance, turn, walk back, and sit down.
The time required to complete the test will be recorded in seconds, with longer times indicating poorer functional mobility.
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Baseline, week 3, and week 6
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Functional Reach Test
Zeitfenster: Baseline, week 3, and week 6
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The Functional Reach Test will be used to assess dynamic balance and postural control.
The maximum distance the participant can reach forward while standing without losing balance will be recorded in centimeters.
Greater reach distance indicates better functional balance.
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Baseline, week 3, and week 6
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Sit-to-Stand Test
Zeitfenster: Baseline, week 3, and week 6
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The sit-to-stand task will be used to assess functional lower extremity performance and postural control during transition from sitting to standing.
The time required to complete the movement will be recorded in seconds using video-based analysis.
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Baseline, week 3, and week 6
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Gait Initiation Time
Zeitfenster: Baseline, week 3, and week 6
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Gait initiation time will be assessed using video-based kinematic analysis.
The time from the auditory cue to the initiation of the first step will be recorded in seconds.
Longer times indicate impaired gait initiation.
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Baseline, week 3, and week 6
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Freezing of Gait Questionnaire (FOGQ)
Zeitfenster: Baseline, week 3, and week 6
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Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOGQ).
The FOGQ evaluates the severity of freezing episodes and their impact on walking performance in patients with Parkinson disease.
The total score ranges from 0 to 24.
Higher scores indicate more severe freezing of gait and worse walking performance.
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Baseline, week 3, and week 6
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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)
8. Februar 2026
Primärer Abschluss (Geschätzt)
1. Juli 2026
Studienabschluss (Geschätzt)
1. August 2026
Studienanmeldedaten
Zuerst eingereicht
10. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Mai 2026
Zuerst gepostet (Tatsächlich)
15. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025/02-44
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Otago Home Exercise Program
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University of ManchesterAbgeschlossen