- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04897256
Mobilitet i dagligdagen og fald i Parkinsons sygdom: Potentiale for rehabilitering
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
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Science University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
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
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Fay Horak, PhD, PT, Oregon Health and Science University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01HD100383 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .