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Mobiliteit in het dagelijks leven en vallen bij de ziekte van Parkinson: potentieel voor revalidatie

4 november 2026 bijgewerkt door: Martina Mancini, Oregon Health and Science University

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

Voltooid

Studietype

Ingrijpend

Inschrijving (Werkelijk)

55

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Oregon Health & Science University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

55 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. 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
  2. Responsive to levodopa
  3. Hoehn & Yahr stages II-IV
  4. Age range 55-85 years old
  5. self-report of one or more falls in past 12 months
  6. 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:

  1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
  2. no medical condition that precludes exercise
  3. Montreal Cognitive Assessment (MoCA) ≤ 21 or inability to follow directions
  4. excessive use of alcohol or recreational drugs
  5. recent change in medication
  6. inability to stand and walk for 2 minutes without an assistive device

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
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.

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
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
Prospective Fall Incidence
Tijdsspanne: 52 weeks

Number of prospective falls recorded for 12 months starting from the end of intervention

52 weeks
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
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
Turn Peak Velocity
Tijdsspanne: 6 weeks

Peak velocity of turns averaged from daily monitoring, as measured at 6 weeks.

6 weeks
Turn Angle Amplitude
Tijdsspanne: 6 weeks

The peak size of turn angles averaged from daily monitoring, as measured at 6 weeks.

6 weeks
Turn Duration
Tijdsspanne: 6 weeks

Time to complete turns averaged from daily monitoring, as measured at 6 weeks.

6 weeks
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
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
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
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
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
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
Stride Velocity
Tijdsspanne: 6 weeks

Stride velocity during straight walking averaged from daily monitoring, as measured at 6 weeks.

6 weeks
Stride Length
Tijdsspanne: 6 weeks

Stride length during straight walking averaged from daily monitoring, as measured at 6 weeks.

6 weeks
Cadence
Tijdsspanne: 6 weeks

The number of straight walking steps taken per minute averaged from daily monitoring, as measured at 6 weeks.

6 weeks
Double Support Time
Tijdsspanne: 6 weeks

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
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
Variability of Angle of Foot at Heel Strike
Tijdsspanne: 6 weeks

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
Number of Turns Per Hour
Tijdsspanne: 6 weeks

The average number of turns per hour measured during daily monitoring at 6 weeks.

6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Fay Horak, PhD, PT, Oregon Health and Science University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 september 2021

Primaire voltooiing (Werkelijk)

30 juni 2025

Studie voltooiing (Werkelijk)

1 juli 2026

Studieregistratiedata

Eerst ingediend

18 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2021

Eerst geplaatst (Werkelijk)

21 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

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

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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