Dual Task Training in Parkinson's Disease
2019년 11월 15일 업데이트: Çağrı Gülşen, Gazi University
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease
The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.
연구 개요
상세 설명
20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group.
And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks.
Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks.
In order to evaluate the effects of the training, evaluations will be performed before and after the training period.
연구 유형
중재적
등록 (예상)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ankara, 칠면조, 06560
- 모병
- Gazi University, Faculty of Health Sciences
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연락하다:
- Çağrı Gülşen
- 전화번호: 05555874415
- 이메일: fztcagri@gmail.com
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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
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- at least 40 years of age
- neurologist-diagnosed Parkinson's Disease
- Hoehn & Yahr (H&Y) stages 1 to 3
- 24 or more mini mental status examination score.
Exclusion Criteria:
- other neurologic disorder
- cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
- had deep brain stimulation history
- visual, auditory, orientational problems that could affect study results
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 |
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실험적: 개입 그룹
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45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.
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활성 비교기: 대조군
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45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Balance-Postural Stability
기간: 8 weeks
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Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately.
Total stability index score will obtained as the test result.
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8 weeks
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Balance- Limits of Stability
기간: 8 weeks
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Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position.
Total direction control score will obtained as the test result.
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8 weeks
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Balance- Modified Sensory Organization Tests
기간: 8 weeks
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Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position.
It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface.
Stability index scores will obtained as the test result.
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8 weeks
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Gait Speed
기간: 8 weeks
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Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Cadence
기간: 8 weeks
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Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride width
기간: 8 weeks
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Stride width will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride length
기간: 8 weeks
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Stride length will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Montreal Cognitive Assessment (MoCA)
기간: 8 weeks
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Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
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8 weeks
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Change in brain derived neurotrophic factor (BDNF) levels of serum
기간: 8 weeks
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Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in vascular endothelial growth factor (VEGF) levels of serum
기간: 8 weeks
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Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in insulin like growth factor 1 (IGF-1) levels of serum
기간: 8 weeks
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Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
기간: 8 weeks
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Hoehn and Yahr Scale is measures level of physical disability in Parkinson's disease and stages patients between level 1 level 5. Higher level indicates worse physical condition.
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8 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS)
기간: 8 weeks
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The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment).
Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score.
The UPDRS total score ranges between 0 and 199 points.
Higher points indicates worse outcome.
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8 weeks
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Berg Balance Scale (BBS)
기간: 8 weeks
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Berg Balance Scale (BBS) is a scale that using for assess postural stability.
It ranges 0-56 with higher score indicates better stability.
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8 weeks
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One-legged Stance Test
기간: 8 weeks
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The duration participant is able to maintain their balance on one leg up to will be recorded.
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8 weeks
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Timed Up and Go (TUG) test
기간: 8 weeks
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Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again.
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8 weeks
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Activities-Specific Balance Confidence (ABC) Scale
기간: 8 weeks
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Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
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8 weeks
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Stroop Test
기간: 8 weeks
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Stroop test will be used to test cognitive function.
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8 weeks
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Trail Making Test (TMT) Part A and B
기간: 8 weeks
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The Trail Making Test is a measure of attention, speed and mental flexibility.
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8 weeks
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Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
기간: 8 weeks
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The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients.
It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all).
The total score ranges from 0 to 32.
Higher scores indicates poorer quality of life.
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8 weeks
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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)
2019년 10월 16일
기본 완료 (예상)
2021년 3월 30일
연구 완료 (예상)
2021년 6월 30일
연구 등록 날짜
최초 제출
2019년 9월 30일
QC 기준을 충족하는 최초 제출
2019년 10월 2일
처음 게시됨 (실제)
2019년 10월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 11월 15일
마지막으로 확인됨
2019년 11월 1일
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. .
파킨슨병에 대한 임상 시험
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Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
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UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of Health모집하지 않고 적극적으로
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Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
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IRCCS Ospedale San Raffaele아직 모집하지 않음방실 재진입성 빈맥 | Wolff-Parkinson-White (WPW) 증후군
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Novartis Pharmaceuticals모병류마티스 관절염 (RA) 및 Sjögren 's Disease (SJD)스페인, 프랑스, 독일, 싱가포르
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Jiulongpo No.1 People's HospitalJiangxi Maternal and Child Health Hospital아직 모집하지 않음
Dual Task Training에 대한 임상 시험
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Children's Cancer Hospital Egypt 57357완전한
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Medical University of ViennaMedical University of Graz아직 모집하지 않음
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Stryker Trauma GmbH완전한대퇴골두 괴사 | 원발성 골관절염 | 선천성 탈구 | 대퇴골 경부 골절 | 고관절의 외상 후 골관절염
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King's College LondonUniversity College, London; Brighton & Sussex Medical School완전한
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New York UniversityNational Institute of Mental Health (NIMH)모병