- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03597451
The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis
The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis
Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity.
The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity.
In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.
연구 개요
상태
정황
상세 설명
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once.
Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ankara, 칠면조
- Gazi University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.
Exclusion Criteria:
- Participants who have orthopedic, vision, hearing, or perception problems
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Multiple sclerosis
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
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Control
Healthy individuals of similar age and sex to patients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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strength of extremity muscles
기간: baseline
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The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).
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baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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6 minutes walking test
기간: baseline
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The Six-Minute Walking Test (6MWT) was performed to determine walking capacity.
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baseline
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timed up and go test
기간: baseline
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Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.
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baseline
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sit-to-stand test
기간: baseline
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In this test, the participants will stand up from and sit down on 43 cm high armless chair as quickly as possible 5 times.
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baseline
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Side Bridge Test (core muscles endurance)
기간: baseline
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The subjects were asked to lay on their left or right sides and to extend their legs fully.
Then The subjects are asked to create a straight line with their body by lifting their hip from the floor.The measurements are recorded with a chronometer as seconds.
The tests end when the subjects break the test positions.
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baseline
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Modified Biering-Sorensen test (core muscles endurance)
기간: baseline
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In this test, the subjects are asked to lie down on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, which allowed the upper body to be planked out over the edge.
The subjects are asked to fold their arms on their chest and to put their hands on their shoulders.
The measurements are recorded with a chronometer as seconds.
The tests end when the subjects break the test positions.
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baseline
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Trunk Flexion Test (core muscles endurance)
기간: baseline
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This test is initiated when the subjects are in a sit-up position with their back resting against a wedge that was angled 55° from the floor.
The measurements are recorded with a chronometer as seconds.
The tests end when the subjects break the test positions.
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baseline
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Prone bridge test (core muscles endurance)
기간: baseline
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In this test, the subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight as they are required not to arch or bow.
The measurements are recorded with a chronometer as seconds.
The tests end when the subjects break the test positions.
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baseline
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4.
- Bliss LS, Teeple P. Core stability: the centerpiece of any training program. Curr Sports Med Rep. 2005 Jun;4(3):179-83. doi: 10.1007/s11932-005-0064-y.
- Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.
- Ketelhut NB, Kindred JH, Manago MM, Hebert JR, Rudroff T. Core muscle characteristics during walking of patients with multiple sclerosis. J Rehabil Res Dev. 2015;52(6):713-24. doi: 10.1682/JRRD.2015.01.0006.
- Fry DK, Huang M, Rodda BJ. Core muscle strength and endurance measures in ambulatory persons with multiple sclerosis: validity and reliability. Int J Rehabil Res. 2015 Sep;38(3):206-12. doi: 10.1097/MRR.0000000000000109.
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 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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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스