- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04115683
Dual Task Training in Parkinson's Disease
15. november 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Ankara, Kalkun, 06560
- Rekruttering
- Gazi University, Faculty of Health Sciences
-
Kontakt:
- Çağrı Gülşen
- Telefonnummer: 05555874415
- E-mail: fztcagri@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Aktiv komparator: Kontrolgruppe
|
45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Balance-Postural Stability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 8 weeks
|
Stroop test will be used to test cognitive function.
|
8 weeks
|
Trail Making Test (TMT) Part A and B
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. oktober 2019
Primær færdiggørelse (Forventet)
30. marts 2021
Studieafslutning (Forventet)
30. juni 2021
Datoer for studieregistrering
Først indsendt
30. september 2019
Først indsendt, der opfyldte QC-kriterier
2. oktober 2019
Først opslået (Faktiske)
4. oktober 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14.01.2019/35
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Parkinsons sygdom
-
Abbott Medical DevicesBaylor College of Medicine; University of HoustonAfsluttet
-
Bial - Portela C S.A.Afsluttet
-
Mayo ClinicAfsluttet
-
Ataturk UniversityRekruttering
-
Centre Hospitalier Universitaire, AmiensUkendtParkinson | ImpulskontrolforstyrrelseFrankrig
-
Institute for Neurodegenerative DisordersAfsluttetParkinson | Parkinsons syndromForenede Stater
-
Assistance Publique - Hôpitaux de ParisCentre Hospitalier Universitaire de Pointe-a-PitreAfsluttet
-
University of MinnesotaTrukket tilbageParkinsons sygdom | ParkinsonForenede Stater
-
National Taiwan University HospitalAfsluttet
-
University of PlymouthIkke rekrutterer endnuParkinsons sygdom | ParkinsonDet Forenede Kongerige
Kliniske forsøg med Dual Task Training
-
Hasselt UniversityTel Aviv University; Sheba Medical Center; Centre Hospitalier Universitaire... og andre samarbejdspartnereAfsluttet
-
Riphah International UniversityIkke rekrutterer endnu
-
Kutahya Health Sciences UniversityAfsluttet
-
Children's Cancer Hospital Egypt 57357AfsluttetMedulloblastom, barndom | BarnekræftEgypten
-
Chang Gung Memorial HospitalUkendt
-
Cairo UniversityRekrutteringMedulloblastom | AtaksiEgypten
-
Riphah International UniversityAfsluttet
-
Federal University of ParaíbaRekrutteringParkinsons sygdom | Kognitionsforstyrrelse | EEG med unormalt langsomme frekvenserBrasilien
-
Tan Tock Seng HospitalNational Neuroscience Institute; Nanyang PolytechnicRekruttering
-
King Saud UniversityAfsluttetSlag | Kronisk slagtilfælde | MellemhjernearterieslagtilfældeSaudi Arabien