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Intensive Multimodal Training for Persons With MS (Treadmill)

2017년 8월 31일 업데이트: Fondazione Don Carlo Gnocchi Onlus

Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial

The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative multimodal training protocol carried out on treadmill on walking efficacy, mobility, balance, executive function, fatigue and health-related quality of life in a sample of persons with moderate to severe MS deficit of mobility compared to a control group that received a strengthening program of similar intensity.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Persons with multiple sclerosis can have various deficits, affecting many aspects of physical and cognitive functioning often leading to low levels of physical activity in daily life. These include poor endurance, muscle weakness, incoordination and poor balance and cognitive deficits that can all lead to persistent mobility difficulties in daily life.

Given the importance of exercise and physical activity for persons with multiple sclerosis that are already moderately to severely hampered by their locomotor ability and balance, the setting up of intense functional mobility training that targets the main deficits, in adjunction to a clinical rehabilitation usual care and under close supervision, may be a viable way of increasing the level of physiological health and give a basis for the persons to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking has several benefits for mobility rehabilitation. First, it is a everyday task, walking. Second it lends itself well to a dual task paradigm where other aspects of mobility, such as equilibrium and cognitive factors can be addressed during walking. Third, even persons with severe walking limitations can train walking at various speeds when on treadmill, holding onto handrails and using safety harnesses that minimize the possibility of adverse events during training. Further, the treadmill paradigm lends itself well to training with progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an aerobic component to improve cardiorespiratory fitness. All of which should lead to improved submaximal exercise tolerance and endurance, more functional mobility and consequently increased ability to carry out activities of daily living.

Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the beginning of the study.

The study design was a two arm randomized 2:1 controlled trial (see study flow chart in Figure 1).

The participants were assessed before and after the rehabilitation period by researchers blinded to group assignment.

Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times per week by experienced physical therapists trained for the study. All participants also followed their usual rehabilitation care protocols as planned.

연구 유형

중재적

등록 (실제)

42

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • MI
      • Milan, MI, 이탈리아, 20148
        • Fondazione don Carlo Gnocchi IRCCS

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Diagnosis of multiple sclerosis according to McDonald's criteria (Polman et al. Ann Neurology 2011)
  • EDSS score <= 7
  • Free from relapses and steroid treatment for at least 1 month)
  • Able to stand 30 seconds,
  • Able to walk at least 10 meters independently or with a cane
  • Able to understand and follow instructions
  • Stable neurological conditions and willingness to participate in the study.

Exclusion Criteria:

  • Cardiac pacemaker
  • Any pre-existing conditions that affected walking function
  • diagnosis of depression or psychotic disorder

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: Treadmill group
Participants in the experimental group received supervised treadmill training
Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
활성 비교기: Resistance group
Participants in the control group were treated with Resistance exercises.
Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Two minute walking test
기간: Two minutes
The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.
Two minutes
Timed up and go test
기간: 1 minute
The Timed Up & Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.
1 minute

2차 결과 측정

결과 측정
측정값 설명
기간
The Frontal Assessment Battery
기간: 10 minutes
The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.
10 minutes
Ten meter walking test
기간: 2 minutes
The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
2 minutes
The Berg Balance Scale
기간: 15 minutes
The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS. BBS provides information about patient's balance-related abilities.
15 minutes
Dynamic Gait Index
기간: 15 minutes
The Dynamic Gait Index (DGI) measures gait function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.
15 minutes
The Short Form-12 questionnaire (SF-12)
기간: 10 minutes
The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.
10 minutes

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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)

2013년 1월 8일

기본 완료 (실제)

2015년 5월 19일

연구 등록 날짜

최초 제출

2017년 8월 31일

QC 기준을 충족하는 최초 제출

2017년 8월 31일

처음 게시됨 (실제)

2017년 9월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 9월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 8월 31일

마지막으로 확인됨

2017년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Treadmill MS

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data

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. .

다발성 경화증에 대한 임상 시험

Treadmill에 대한 임상 시험

유사한 임상시험 검색