- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04897256
Mobilità nella vita quotidiana e cadute nella malattia di Parkinson: potenziale per la riabilitazione
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97239
- Oregon Health & Science University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Variability in Number of Steps to Complete a Turn
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Falls Efficacy Scale International
Lasso di tempo: 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
Lasso di tempo: 52 weeks
|
Number of prospective falls recorded for 12 months starting from the end of intervention |
52 weeks
|
|
Patient Global Impression of Change
Lasso di tempo: 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
Lasso di tempo: 6 weeks
|
The number of steps in a turning averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Turn Peak Velocity
Lasso di tempo: 6 weeks
|
Peak velocity of turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Turn Angle Amplitude
Lasso di tempo: 6 weeks
|
The peak size of turn angles averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Turn Duration
Lasso di tempo: 6 weeks
|
Time to complete turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Variability of Double-support Time
Lasso di tempo: 6 weeks
|
The coefficient of variation in time of double-support phase, as measured at 6 weeks. |
6 weeks
|
|
Lateral Trunk Range
Lasso di tempo: 6 weeks
|
The range of motion in the trunk during walking, in the lateral direction, as measured at 6 weeks. |
6 weeks
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Mini-Balance Evaluation Systems Test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 weeks
|
Stride velocity during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Stride Length
Lasso di tempo: 6 weeks
|
Stride length during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Cadence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 weeks
|
The average number of turns per hour measured during daily monitoring at 6 weeks. |
6 weeks
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Fay Horak, PhD, PT, Oregon Health and Science University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01HD100383 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Upon reasonable request, we can share de-identified data related to study outcomes measures.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .