- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04115683
Dual Task Training in Parkinson's Disease
15. november 2019 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ankara, Tyrkia, 06560
- Rekruttering
- Gazi University, Faculty of Health Sciences
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Ta kontakt med:
- Çağrı Gülşen
- Telefonnummer: 05555874415
- E-post: fztcagri@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervensjonsgruppe
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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.
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Aktiv komparator: Kontrollgruppe
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45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Balance-Postural Stability
Tidsramme: 8 weeks
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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.
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8 weeks
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Balance- Limits of Stability
Tidsramme: 8 weeks
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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.
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8 weeks
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Balance- Modified Sensory Organization Tests
Tidsramme: 8 weeks
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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.
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8 weeks
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Gait Speed
Tidsramme: 8 weeks
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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.
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8 weeks
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Cadence
Tidsramme: 8 weeks
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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.
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8 weeks
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Stride width
Tidsramme: 8 weeks
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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.
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8 weeks
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Stride length
Tidsramme: 8 weeks
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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.
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8 weeks
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Montreal Cognitive Assessment (MoCA)
Tidsramme: 8 weeks
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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.
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8 weeks
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Change in brain derived neurotrophic factor (BDNF) levels of serum
Tidsramme: 8 weeks
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Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in vascular endothelial growth factor (VEGF) levels of serum
Tidsramme: 8 weeks
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Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in insulin like growth factor 1 (IGF-1) levels of serum
Tidsramme: 8 weeks
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Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
Tidsramme: 8 weeks
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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.
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8 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS)
Tidsramme: 8 weeks
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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.
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8 weeks
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Berg Balance Scale (BBS)
Tidsramme: 8 weeks
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Berg Balance Scale (BBS) is a scale that using for assess postural stability.
It ranges 0-56 with higher score indicates better stability.
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8 weeks
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One-legged Stance Test
Tidsramme: 8 weeks
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The duration participant is able to maintain their balance on one leg up to will be recorded.
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8 weeks
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Timed Up and Go (TUG) test
Tidsramme: 8 weeks
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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.
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8 weeks
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Activities-Specific Balance Confidence (ABC) Scale
Tidsramme: 8 weeks
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Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
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8 weeks
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Stroop Test
Tidsramme: 8 weeks
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Stroop test will be used to test cognitive function.
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8 weeks
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Trail Making Test (TMT) Part A and B
Tidsramme: 8 weeks
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The Trail Making Test is a measure of attention, speed and mental flexibility.
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8 weeks
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Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Tidsramme: 8 weeks
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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.
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8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. oktober 2019
Primær fullføring (Forventet)
30. mars 2021
Studiet fullført (Forventet)
30. juni 2021
Datoer for studieregistrering
Først innsendt
30. september 2019
Først innsendt som oppfylte QC-kriteriene
2. oktober 2019
Først lagt ut (Faktiske)
4. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. november 2019
Sist bekreftet
1. november 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14.01.2019/35
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