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- Klinische proef NCT04897256
Mobiliteit in het dagelijks leven en vallen bij de ziekte van Parkinson: potentieel voor revalidatie
The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
- Oregon Health & Science University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- Responsive to levodopa
- Hoehn & Yahr stages II-IV
- Age range 55-85 years old
- self-report of one or more falls in past 12 months
- willing and able to attend exercise intervention sessions at Oregon Health & Science University (OHSU) campus, and also refrain from changes in anti-parkinson medications and exercise levels.
Exclusion Criteria:
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- no medical condition that precludes exercise
- Montreal Cognitive Assessment (MoCA) ≤ 21 or inability to follow directions
- excessive use of alcohol or recreational drugs
- recent change in medication
- inability to stand and walk for 2 minutes without an assistive device
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: TURN-IT group
Participants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator. |
Based on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focuses on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting and increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging (such as adding a dual task). Initially participants will be supported in an overhead body-weight support system (ZeroG) to allow them to practice challenging exercises without the risk of falling. |
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Geen tussenkomst: No Intervention Control Group
Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Variability in Number of Steps to Complete a Turn
Tijdsspanne: 6 weeks
|
The coefficient of variation in the number of steps in a turn, averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Falls Efficacy Scale International
Tijdsspanne: baseline and 6 weeks
|
The difference in the Falls Efficacy Scale, as measured at baseline and 6 weeks. The Falls Efficacy Scale is a 16 item self-administered questionnaire to assess fear of falling. Scores range 16-64 with higher score indicating more fear of falling. |
baseline and 6 weeks
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Prospective Fall Incidence
Tijdsspanne: 52 weeks
|
Number of prospective falls recorded for 12 months starting from the end of intervention |
52 weeks
|
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Patient Global Impression of Change
Tijdsspanne: 6 weeks
|
Question of participant's rating of mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility. Single score provided at the end of 6 week period. |
6 weeks
|
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Number of Steps to Complete a Turn
Tijdsspanne: 6 weeks
|
The number of steps in a turning averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Turn Peak Velocity
Tijdsspanne: 6 weeks
|
Peak velocity of turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Turn Angle Amplitude
Tijdsspanne: 6 weeks
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The peak size of turn angles averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Turn Duration
Tijdsspanne: 6 weeks
|
Time to complete turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Variability of Double-support Time
Tijdsspanne: 6 weeks
|
The coefficient of variation in time of double-support phase, as measured at 6 weeks. |
6 weeks
|
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Lateral Trunk Range
Tijdsspanne: 6 weeks
|
The range of motion in the trunk during walking, in the lateral direction, as measured at 6 weeks. |
6 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Mini-Balance Evaluation Systems Test
Tijdsspanne: baseline and 6 weeks
|
The change in mini-Balance Evaluation Systems Test, a clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait, as measured at baseline and 6 weeks. Scores range from 0-28 with higher scores indicating worse balance. |
baseline and 6 weeks
|
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Clinical Global Impression of Change
Tijdsspanne: 6 weeks
|
Question of clinician's rating of participant mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility. Single score provided at the end of 6 week period. |
6 weeks
|
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Change in Parkinson's Disease Questionnaire-39
Tijdsspanne: baseline and 6 weeks
|
The difference in the Parkinson's disease questionnaire-39 (PDQ-39) - a 39 item self-report questionnaire to assess Parkinson's disease specific health related quality in eight domains of quality of life - as measured at baseline and 6 weeks. Each item scores from 0 (never) to 4 (always). Sub-scale scores and a Parkinson's Disease summary index (PDSI; sum of eight subsections/8) representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life |
baseline and 6 weeks
|
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Change in Unified Parkinson's Disease Rating Scale, Part III
Tijdsspanne: baseline and 6 weeks
|
Difference in the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), as measured at baseline and 6 weeks. The UPDRS-III is a clinical scale to assess severity of motor symptoms in Parkinson's disease. Each item is scored 0 (normal) to 4 (severe) with a score range from 0-132 |
baseline and 6 weeks
|
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Change in Activities-Specific Balance Confidence Scale
Tijdsspanne: baseline and 6 weeks
|
The difference in Activities-Specific Balance Confidence (ABC) Scale, as measured at baseline and 6 weeks. The ABC Scale is a 16-item self-report scale that participants rate their confidence in performing daily activities. Score range from 0-100% with 0% meaning no confidence and 100% completely confident |
baseline and 6 weeks
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Stride Velocity
Tijdsspanne: 6 weeks
|
Stride velocity during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Stride Length
Tijdsspanne: 6 weeks
|
Stride length during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Cadence
Tijdsspanne: 6 weeks
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The number of straight walking steps taken per minute averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Double Support Time
Tijdsspanne: 6 weeks
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The amount of time both feet were on the ground together during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Angle of Foot at Heel Strike
Tijdsspanne: 6 weeks
|
The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Variability of Angle of Foot at Heel Strike
Tijdsspanne: 6 weeks
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Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Number of Turns Per Hour
Tijdsspanne: 6 weeks
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The average number of turns per hour measured during daily monitoring at 6 weeks. |
6 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Fay Horak, PhD, PT, Oregon Health and Science University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R01HD100383 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Upon reasonable request, we can share de-identified data related to study outcomes measures.
IPD-tijdsbestek voor delen
Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.
IPD-toegangscriteria voor delen
Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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