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일상생활의 이동성과 파킨슨병의 낙상: 재활의 가능성

2026년 11월 4일 업데이트: 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.

연구 개요

상태

완전한

정황

연구 유형

중재적

등록 (실제)

55

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Oregon
      • Portland, Oregon, 미국, 97239
        • Oregon Health & Science University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
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.

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
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
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
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
Turn Peak Velocity
기간: 6 weeks

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

6 weeks
Turn Angle Amplitude
기간: 6 weeks

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

6 weeks
Turn Duration
기간: 6 weeks

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

6 weeks
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
Lateral Trunk Range
기간: 6 weeks

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
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
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
Stride Velocity
기간: 6 weeks

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

6 weeks
Stride Length
기간: 6 weeks

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

6 weeks
Cadence
기간: 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
기간: 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
기간: 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
기간: 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
기간: 6 weeks

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

6 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 9월 13일

기본 완료 (실제)

2025년 6월 30일

연구 완료 (실제)

2026년 7월 1일

연구 등록 날짜

최초 제출

2021년 5월 18일

QC 기준을 충족하는 최초 제출

2021년 5월 18일

처음 게시됨 (실제)

2021년 5월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

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?

예

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

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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