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Mobilitet i dagligdagen og fald i Parkinsons sygdom: Potentiale for rehabilitering

4. november 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University

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

55 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

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: 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.

Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Variability in Number of Steps to Complete a Turn
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Falls Efficacy Scale International
Tidsramme: 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
Tidsramme: 52 weeks

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

52 weeks
Patient Global Impression of Change
Tidsramme: 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
Tidsramme: 6 weeks

The number of steps in a turning averaged from daily monitoring, as measured at 6 weeks.

6 weeks
Turn Peak Velocity
Tidsramme: 6 weeks

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

6 weeks
Turn Angle Amplitude
Tidsramme: 6 weeks

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

6 weeks
Turn Duration
Tidsramme: 6 weeks

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

6 weeks
Variability of Double-support Time
Tidsramme: 6 weeks

The coefficient of variation in time of double-support phase, as measured at 6 weeks.

6 weeks
Lateral Trunk Range
Tidsramme: 6 weeks

The range of motion in the trunk during walking, in the lateral direction, as measured at 6 weeks.

6 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mini-Balance Evaluation Systems Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 weeks

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

6 weeks
Stride Length
Tidsramme: 6 weeks

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

6 weeks
Cadence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 weeks

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

6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

13. september 2021

Primær færdiggørelse (Faktiske)

30. juni 2025

Studieafslutning (Faktiske)

1. juli 2026

Datoer for studieregistrering

Først indsendt

18. maj 2021

Først indsendt, der opfyldte QC-kriterier

18. maj 2021

Først opslået (Faktiske)

21. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Upon reasonable request, we can share de-identified data related to study outcomes measures.

IPD-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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