- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02408718
Assistive Device Training in Multiple Sclerosis (ADT)
Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
연구 개요
상세 설명
40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.
The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.
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
- VA Portland Health Care System
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Multiple Sclerosis of any type,
- self-reported history of at least 1 fall in the previous year,
- able to walk at least 25 feet with or without an assistive device,
- clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
- intermittent or constant unilateral or bilateral assistance required to walk,
- right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.
Exclusion Criteria:
- serious psychiatric or medical conditions that would preclude reliable participation in the study,
- dementia (MMSE <24),
- deafness,
- blindness,
- inability to follow directions in English,
- significant upper extremity tremor or weakness,
- more than 1 hour of assistive device training within the previous 3 years,
- any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Training group
Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device.
They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later.
During this time, their falls will be recorded monthly using prospective falls calendars.
Members of this group will also receive MRI scans at baseline and after the completion of the training program.
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Six-week training program on the proper use of the subject's assistive device (eg.
cane, walker, etc).
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간섭 없음: Wait-list control
Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time.
These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed.
These subjects will not receive MRI scans.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
기간: At baseline, 1 week after completion of training, 3 months later
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Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
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At baseline, 1 week after completion of training, 3 months later
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Change from Baseline in Falls at Completion of Training and the Following Three Months
기간: First week of training, last week of training, 3 months later
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Change in rate of falls between time frames
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First week of training, last week of training, 3 months later
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Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
기간: At baseline, 1 week after completion of training
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Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
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At baseline, 1 week after completion of training
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
기간: At baseline, 1 week after completion of training, 3 months later
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Quebec User Evaluation of Satisfaction with Assistive Technologies
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At baseline, 1 week after completion of training, 3 months later
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Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
기간: At baseline, 1 week after completion of training, 3 months later
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Activities-specific Balance Confidence Questionnaire
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At baseline, 1 week after completion of training, 3 months later
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Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
기간: At baseline, 1 week after completion of training, 3 months later
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Multiple Sclerosis Impact Scale-29
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At baseline, 1 week after completion of training, 3 months later
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Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
기간: At baseline, 1 week after completion of training, 3 months later
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International Physical Activity Questionnaire
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At baseline, 1 week after completion of training, 3 months later
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michelle H. Cameron, MD, PT MCR, Portland VA Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3559
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. .
다발성 경화증에 대한 임상 시험
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