- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04897256
일상생활의 이동성과 파킨슨병의 낙상: 재활의 가능성
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Variability in Number of Steps to Complete a Turn
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Falls Efficacy Scale International
기간: 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
기간: 52 weeks
|
Number of prospective falls recorded for 12 months starting from the end of intervention |
52 weeks
|
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Patient Global Impression of Change
기간: 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
|
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Number of Steps to Complete a Turn
기간: 6 weeks
|
The number of steps in a turning averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Turn Peak Velocity
기간: 6 weeks
|
Peak velocity of turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Turn Angle Amplitude
기간: 6 weeks
|
The peak size of turn angles averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Turn Duration
기간: 6 weeks
|
Time to complete turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
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Variability of Double-support Time
기간: 6 weeks
|
The coefficient of variation in time of double-support phase, as measured at 6 weeks. |
6 weeks
|
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Lateral Trunk Range
기간: 6 weeks
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The range of motion in the trunk during walking, in the lateral direction, as measured at 6 weeks. |
6 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Mini-Balance Evaluation Systems Test
기간: 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
기간: 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
|
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Change in Parkinson's Disease Questionnaire-39
기간: 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
|
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Change in Unified Parkinson's Disease Rating Scale, Part III
기간: 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
기간: 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
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Stride Velocity
기간: 6 weeks
|
Stride velocity during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Stride Length
기간: 6 weeks
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Stride length during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Cadence
기간: 6 weeks
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The number of straight walking steps taken per minute averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
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Double Support Time
기간: 6 weeks
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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
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Angle of Foot at Heel Strike
기간: 6 weeks
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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
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Variability of Angle of Foot at Heel Strike
기간: 6 weeks
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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
|
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Number of Turns Per Hour
기간: 6 weeks
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The average number of turns per hour measured during daily monitoring at 6 weeks. |
6 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Fay Horak, PhD, PT, Oregon Health and Science University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- R01HD100383 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Upon reasonable request, we can share de-identified data related to study outcomes measures.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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