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Long-Term Effects of Torso-Weighting (TWPS)

2018년 10월 9일 업데이트: San Francisco State University

Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study

The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The hypotheses of this study include: torso weighting will (1) increase physical activity, (2) decrease the number of falls, and (3) improve the timing and coordination of muscle activation during balance perturbations.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Torso weighting, using the balance-based torso-weighting (BBTW) method, is an intervention that addresses balance by first challenging stability in standing using a series of perturbations (nudges) and resisted rotations to people. Challenging stability allows the assessor to determine directional instability. Once the direction of instability is determined, small weights are placed on a vest-like garment and retesting of balance occurs. In this study, participants will be tested with no weights (NW), with sham weights (SW), and with BBTW weighting (WT). Following non-weighted baseline assessment, participants will be randomly allocated into the sham weight condition or BBTW weight condition in a cross-over design. The initial condition (NW) will last four weeks and the final two conditions (SW,WT) will last two weeks each. Following each condition, outcome measures will be reassessed. Throughout the study, participants will be asked to wear a commercially-available remote monitoring device (e.g., Fitbit Flex) and keep a daily log of physical activity and number of falls. During the SW and WT conditions, participants will wear the assigned garment for 2-4 hours daily.

연구 유형

중재적

등록 (실제)

5

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • California
      • Oakland, California, 미국, 94609
        • Samuel Merritt University, Motion Analysis Research Center

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Self-reported a diagnosis of multiple sclerosis
  • Self-reported mild or moderate gait or balance difficulties
  • Living in the community rather than in a care facility
  • Able to walk independently for at least one minute at a time with or without an assistive device
  • No exacerbations within the past 2 months
  • Able to get to the testing area and tolerate 2-3 hours of testing for each assessment occasion
  • Willing to be nudged by a researcher when standing

Exclusion Criteria:

  • Unable to comprehend and follow instructions in English
  • Current diagnosis of other neurological disorders such as head injury, stroke, Parkinson disease, or other conditions that affect gait or balance (self-reported)
  • Experiencing pain that could be exacerbated by external perturbation while standing
  • History of skin reaction to adhesives

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: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Torso Weights then Sham Weights

No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks.

Participants wear the Fitbit Flex throughout.
장치: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
다른 이름들:
  • WT
장치: Sham Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
다른 이름들:
  • 남서
장치: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
다른 이름들:
  • remote activity monitoring device
실험적: Sham Weights then Torso Weights

No weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks.

Participants wear the Fitbit Flex throughout.
장치: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
다른 이름들:
  • WT
장치: Sham Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
다른 이름들:
  • 남서
장치: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
다른 이름들:
  • remote activity monitoring device

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Steps Per Day
기간: up to 8 weeks
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
up to 8 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Sensory Organization Test
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
balance tested during 6 conditions on Neuro-com forceplate and surround and reported as a composite score (across the six conditions), 0-100, with higher scores indicating better balance; measure reported reflects change in the composite score from the visit that initiates Torso-weighting (TW) or sham weights (SW) to the visit that concludes daily wearing of TW or SW
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Gait Velocity
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Online self-report of perceived current movement ability and preferred movement ability. The scores are reported in standardized logits, 0-6, where 6 is competitive level athletic movement. The reported values are the average change in current movement ability from initiation of daily wear to after 2 weeks of daily wear of TW or SW.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Activities-Specific Balance Confidence Scale
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Self-report measure of perception of confidence under various balance challenges on a scale of 0-100 with 100 being fully confident that the individual can perform the listed balance challenge without falling. Data reported reflect the difference in scores from initiation to the 2-week point after initiation of TW or SW.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Impact Scale 29
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Self-report measure of the impact of MS on activities and participation. The scale is reported in a physical and psychological subscale, with higher numbers (out of 100) indicating worse impact of multiple sclerosis (MS) on function. Data are reported as change from initiation of TW or SW to end of 2 weeks of daily wear.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Walking Scale 12
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Self-report measure of the effect of MS on walking ability. Larger numbers out of 100 mean that MS limits walking much more. Data are reported as change in score from initiation of TW or SW to the visit after 2 weeks of daily wear of TW or SW.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Six-Minute Walk Test
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
distance participant walks in 6 minutes. Larger numbers indicate more distance covered. Data reported are the change in distance walked from initiation of TW or SW to after 2 weeks of daily wear.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Stride Length
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Percent of Gait Cycle in Single Limb Support
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Step Width
기간: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
As measured using instrumented gait mat.
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Electromyography to Assess Muscle Activation
기간: Week 4, Week 6, Week 8
Recording of muscle activation during quiet and perturbed standing before and after intervention at weeks 4, 6, and 8. Average values with and without weighting during each visit.
Week 4, Week 6, Week 8
Number of Falls Recorded in 2 Weeks of Wear Time.
기간: count of number of falls recorded at the end of two weeks of wearing TW or SW
Daily log manually recorded by participant for the 2 weeks of wear time. This is a descriptive measure recording the total count (number) of falls per arm.
count of number of falls recorded at the end of two weeks of wearing TW or SW

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

San Francisco State University

협력자

Samuel Merritt University

수사관

  • 수석 연구원: Diane Allen, PhD, San Francisco State University

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

2015년 11월 1일

기본 완료 (실제)

2016년 5월 1일

연구 완료 (실제)

2016년 6월 1일

연구 등록 날짜

최초 제출

2015년 10월 7일

QC 기준을 충족하는 최초 제출

2016년 4월 18일

처음 게시됨 (추정)

2016년 4월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 9일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • X15-48a

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