- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01917903
Cognitive-motor Training for PD
14. januar 2022 opdateret af: Lisa Muratori, Stony Brook University
The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.
This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously.
By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD.
Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty.
Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention.
The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone.
Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking.
During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into two training groups and asked to come to the lab three times a week for four weeks during the intervention.
One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit.
The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Stony Brook, New York, Forenede Stater, 11794-6018
- Stony Brook University RRAMP Laboratory
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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
21 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease with our without cognitive impairment
- ambulatory for at least 200 feet without an assistive device (cane, walker, etc)
Exclusion Criteria:
- recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
- concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
- cardiac insufficiency limiting ability to participate in walking study
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: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Identification of at risk variables
Individuals will come in for a single visit to perform all tasks / conditions.
Measurements will be taken of spatial and temporal features of walking with and without a secondary task.
In addition, cognitive tests of memory and attention will be performed.
Outcomes will narrow measures to those most likely to show clinically significant change.
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Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive).
Spatiotemporal measures of gait will be collected.
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Eksperimentel: Gait-Cognitive training
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
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Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Spatiotemporal measures of gait across conditions and over time.
Tidsramme: Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)
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Changes in gait parameters are a key measure of the difficulty of performing two tasks at once.
Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.
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Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in cognitive performance measured with serial sevens.
Tidsramme: Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)
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Participants will count backward by sevens from a digit between 90 and 100.
The ability to perform the task will be used as a measure of cognitive trade-off relative to walking performance.
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Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lisa M Muratori, Stony Brook University
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)
26. oktober 2020
Primær færdiggørelse (Faktiske)
17. december 2021
Studieafslutning (Forventet)
15. december 2022
Datoer for studieregistrering
Først indsendt
30. juli 2013
Først indsendt, der opfyldte QC-kriterier
5. august 2013
Først opslået (Skøn)
7. august 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 64249
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