- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02047825
Upper Limbs Intervention in Multiple Sclerosis
Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis
연구 개요
상세 설명
The total estimated prevalence rate of multiple sclerosis has been reported to be 83 per 100 000 for the past three decades. It is also higher in northern countries and between females with a male ratio around 2.0. The highest prevalence rates have been estimated for the age group 35-64 years. The estimated European mean annual Multiple Sclerosis incidence rate is 4.3 cases per 100 000.
Multiple sclerosis can cause a variety of symptoms: hypoesthesia, muscle weakness, abnormal muscle spasms, or difficulty moving; difficulties with coordination and balance; dysarthria, dysphagia, visual problems fatigue and acute or chronic pain syndromes, bladder and bowel difficulties,cognitive impairment, or emotional symptomatology. The investigators focus on the benefits of an intervention on dexterity, strength, coordination and functionality.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Granada, 스페인, 18071
- Faculty of Health Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients diagnosed with multiple sclerosis.
- Subjects who can complete the assessment battery of tests at the beginning and at the end of the study
Exclusion Criteria:
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Sensorial disturbances.
- Traumatic pathology of the hand.
- Concomitant neurological conditions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Experimental group
The patients included in this group will receive an intensive intervention based on upper limbs intervention with exercises added to the usual treatment they receive.
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An 8-week intervention with different exercises will be performed.
This intervention will focus on upper limbs.
The exercises will include plaster of resistance, elastic bands and other exercises.
다른 이름들:
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활성 비교기: Control group
Patients with multiple sclerosis not included in the intensive intervention.
They receive the usual treatment of occupational and physical therapy.
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Occupational therapy and physiotherapy, twice a week, as usual.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in manual dexterity
기간: baseline, 8 weeks
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Changes from baseline to postintervention in manual dexterity assessed by the Purdue Pegboard test and coin rotation task.
The Purdue pegboard test is a timed physical test used to measure manual dexterity.
Test subjects are asked to place small pins into holes in the pegboard using a specific hand and following a specific process.
The coin rotation task consists of rotate the coin during 10 seconds.
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baseline, 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Changes in apraxia
기간: baseline, 8 weeks
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Changes in apraxia from baseline to postintervention is going to be measured using the Apraxia Screen of Tulia.
This is a screening test of upper limbs apraxia.
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baseline, 8 weeks
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Changes in grip strength
기간: baseline, 8 weeks
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The changes in the grip strength will be measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side.
During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°.
The maximum value achieved from all six attempts was used in analyses.
kg/cm2.
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baseline, 8 weeks
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Change in fatigue
기간: baseline, 8 weeks
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The fatigue change is going to be measured using the Fatigue Severity Scale, a 9-item scale focus on the severity of fatigue and how much it affects the person's activities and lifestyle in the patients.
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baseline, 8 weeks
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Upper limb functioning
기간: baseline, 8 weeks
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The upper limb functioning is going to be measured with the Action Research Arm Test, it is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).
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baseline, 8 weeks
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Pinch strength
기간: baseline, 8 weeks
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Pinch strength is going to be measured using a pinch dynamometer.
The participants were asked to perform three repetitions on each side with five seconds rest provided between the measures.
This was performed using the alternating-hands method, which allows rest between repetitions as the examiner records information and provides instructions for the alternate hand.
Three pinchs were evaluated: lateral, distal and tripod pinch
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baseline, 8 weeks
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Tapping speed
기간: baseline, 8 weeks
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The tapping speed will be measured with the finger tapping test.
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baseline, 8 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of life
기간: Baseline, 8 weeks
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Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
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Baseline, 8 weeks
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Goals achievement
기간: baseline, 8 weeks
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The achievement of the goals of the intervention will be measured with the Goal Attainment Scale, a method of scoring the extent to which patient's individual goals are achieved in the course of intervention.
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baseline, 8 weeks
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Functionality
기간: baseline, 8 weeks
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Functionality will be measured with the Functional Independence Measure, a questionnaire.
This is the most widely accepted functional assessment measure in use in the rehabilitation community
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baseline, 8 weeks
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공동 작업자 및 조사자
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 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
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University of North Carolina, Chapel HillFoundation of Hope, North Carolina; OpenBiome빼는
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The University of Hong KongResearch Grants Council, Hong Kong모집하지 않고 적극적으로