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Dual Task Training in Parkinson's Disease

15. November 2019 aktualisiert von: Çağrı Gülşen, Gazi University

Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease

The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.

Studienübersicht

Detaillierte Beschreibung

20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group. And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks. Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks. In order to evaluate the effects of the training, evaluations will be performed before and after the training period.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Ankara, Truthahn, 06560
        • Rekrutierung
        • Gazi University, Faculty of Health Sciences
        • Kontakt:

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

40 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • at least 40 years of age
  • neurologist-diagnosed Parkinson's Disease
  • Hoehn & Yahr (H&Y) stages 1 to 3
  • 24 or more mini mental status examination score.

Exclusion Criteria:

  • other neurologic disorder
  • cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
  • had deep brain stimulation history
  • visual, auditory, orientational problems that could affect study results

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
Experimental: Interventionsgruppe
45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.
Aktiver Komparator: Kontrollgruppe
45 minutes of single task training consisting of same motor activities (walking, balance... etc.)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Balance-Postural Stability
Zeitfenster: 8 weeks
Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately. Total stability index score will obtained as the test result.
8 weeks
Balance- Limits of Stability
Zeitfenster: 8 weeks
Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position. Total direction control score will obtained as the test result.
8 weeks
Balance- Modified Sensory Organization Tests
Zeitfenster: 8 weeks
Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position. It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface. Stability index scores will obtained as the test result.
8 weeks
Gait Speed
Zeitfenster: 8 weeks
Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.
8 weeks
Cadence
Zeitfenster: 8 weeks
Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.
8 weeks
Stride width
Zeitfenster: 8 weeks
Stride width will be evaluated by using the BTS-G Walk system and recorded as meters. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.
8 weeks
Stride length
Zeitfenster: 8 weeks
Stride length will be evaluated by using the BTS-G Walk system and recorded as meters. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.
8 weeks
Montreal Cognitive Assessment (MoCA)
Zeitfenster: 8 weeks
Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
8 weeks
Change in brain derived neurotrophic factor (BDNF) levels of serum
Zeitfenster: 8 weeks
Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
8 weeks
Change in vascular endothelial growth factor (VEGF) levels of serum
Zeitfenster: 8 weeks
Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
8 weeks
Change in insulin like growth factor 1 (IGF-1) levels of serum
Zeitfenster: 8 weeks
Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
8 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
Zeitfenster: 8 weeks
Hoehn and Yahr Scale is measures level of physical disability in Parkinson's disease and stages patients between level 1 level 5. Higher level indicates worse physical condition.
8 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
Zeitfenster: 8 weeks
The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment). Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score. The UPDRS total score ranges between 0 and 199 points. Higher points indicates worse outcome.
8 weeks
Berg Balance Scale (BBS)
Zeitfenster: 8 weeks
Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability.
8 weeks
One-legged Stance Test
Zeitfenster: 8 weeks
The duration participant is able to maintain their balance on one leg up to will be recorded.
8 weeks
Timed Up and Go (TUG) test
Zeitfenster: 8 weeks
Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again.
8 weeks
Activities-Specific Balance Confidence (ABC) Scale
Zeitfenster: 8 weeks
Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
8 weeks
Stroop Test
Zeitfenster: 8 weeks
Stroop test will be used to test cognitive function.
8 weeks
Trail Making Test (TMT) Part A and B
Zeitfenster: 8 weeks
The Trail Making Test is a measure of attention, speed and mental flexibility.
8 weeks
Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Zeitfenster: 8 weeks
The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total score ranges from 0 to 32. Higher scores indicates poorer quality of life.
8 weeks

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)

16. Oktober 2019

Primärer Abschluss (Voraussichtlich)

30. März 2021

Studienabschluss (Voraussichtlich)

30. Juni 2021

Studienanmeldedaten

Zuerst eingereicht

30. September 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Oktober 2019

Zuerst gepostet (Tatsächlich)

4. Oktober 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. November 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. November 2019

Zuletzt verifiziert

1. November 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

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

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