Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Rörlighet i det dagliga livet och fall vid Parkinsons sjukdom: potential för rehabilitering

4 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

55

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Oregon Health & Science University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

55 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Variability in Number of Steps to Complete a Turn
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Falls Efficacy Scale International
Tidsram: 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
Tidsram: 52 weeks

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

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

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

6 weeks
Turn Peak Velocity
Tidsram: 6 weeks

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

6 weeks
Turn Angle Amplitude
Tidsram: 6 weeks

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

6 weeks
Turn Duration
Tidsram: 6 weeks

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

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

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

6 weeks
Lateral Trunk Range
Tidsram: 6 weeks

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

6 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Mini-Balance Evaluation Systems Test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 weeks

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

6 weeks
Stride Length
Tidsram: 6 weeks

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

6 weeks
Cadence
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 weeks

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

6 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 september 2021

Primärt slutförande (Faktisk)

30 juni 2025

Avslutad studie (Faktisk)

1 juli 2026

Studieregistreringsdatum

Först inskickad

18 maj 2021

Först inskickad som uppfyllde QC-kriterierna

18 maj 2021

Första postat (Faktisk)

21 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera