- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04036383
Effects of Different Type Exercise Trainings on Functionality in Older Fallers
2020년 1월 14일 업데이트: Ayşe Abit Kocaman
The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller
연구 개요
상태
완전한
정황
상세 설명
Individuals participating in the study will be blinded and 30 elderly individuals will be included.
Sociodemographic information of individuals, Mini Mental State Test, Fall Efficacy Scale, Dynamic Gait Index, Montreal Cognitive Assessment Scale, Daily Life Activities Scale for Vestibular Disorders, World Health Organization Quality of Life Scale-Elderly Module test results will be recorded.
Hip flexors and abductors, m.quadriceps femoris and m.tibialis anterior muscle strength will be measured by manual muscle dynamometer.
In balance assessments; sensory organization test and adaptation test of computerized dynamic posturography will be recorded.
Individuals will be divided into 3 groups by blocking and stratification randomization method.
All individuals in the group will perform vestibular exercise training twice a day for 8 weeks as a home exercise program.
In the first group, vestibular exercise training will be used as a home program, in the second group, individual rehabilitation program will be applied to the computerized balance system and in the third group, square step exercises will be applied.
Exercise training will be held 3 times a week for 8 weeks.
연구 유형
중재적
등록 (실제)
30
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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Kırıkkale, 칠면조
- Kırıkkale University
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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
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 65 years and older individuals,
- Mini Mental State Examination Test score above 24,
- At least two falls in the last year
- Independent individuals in mobilization without walking aid
Exclusion Criteria:
- Cardiac diseases
- Pulmonary embolism and deep vein thrombosis in the last three months,
- A history of cerebral aneurysm or intracranial hemorrhage,
- Acute retinal hemorrhage or previous ophthalmic surgery,
- Active infection,
- Multiple organ failure,
- Terminal disease status,
- A history of fractures in the lower and upper extremities within the last three months,
- Severe hearing and vision loss,
- Patients with Alzheimer's disease, Parkinson's disease, dementia
- Patients diagnosed with Benign Paroxysmal Positional Vertigo,
- Those who have received exercise training in the last 6 months,
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: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: vestibüler
vestibular exercise training
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The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
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실험적: balance training
vestibular exercise training+ balance training with computerized balance system
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The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
|
|
실험적: square-step
vestibular exercise training+ square step exercise
|
The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided.
Qualitative information reflects progression during static and dynamic postural exercises of the patient.
To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises.
The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts.
Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty.
The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Balance Function Assessment-Sensory Organization Test
기간: 5 minutes
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Sensory Organization Test (SOT): This is a six-part test that objectively identifies abnormalities in somatosensory, visual, and vestibular systems that provide postural control. The result is a ratio between 0-100 and 100 means perfect stability. |
5 minutes
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Cognitive Function assessment
기간: 10 minutes
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Cognitive function will be assessed with "Montreal Cognitive Assessment Scale(MoCA)"The MoCA is a screening instrument that evaluates cognitive domains on a single page and scores range from 0 to 30."0" points indicate poor cognitive functions, "30" points indicate good cognitive functions.
Increase in scores indicates better cognitive functions.
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10 minutes
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Gait Function assessment
기간: 15 minutes
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Dynamic Gait Index will be used to evaluate the adaptations during the patient's gait.
It evaluates activities such as slow walking, fast walking, walking with head movements, turning, stepping up, jumping obstacles, 0 points are weak and 3 points are successful.
Low scores from the scale are indicative of disorders that may cause falls.A total of 8 parameters are evaluated over 24 points.
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15 minutes
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Balance Function Assessment- Adaptation Test
기간: 5 minutes
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Adaptation Test (ADT):This test evaluates the patient's response to sudden changes and irregularities in the ground and the ability to reduce oscillations.
The oscillation energy score is obtained by measuring the force applied to the force platform for recovery.
Scores between 0 and 200.Since the maximum score given by the device is 200, the score of that test is considered as 200 in case of a fall.
The oscillation energy score is close to 0, indicating better postural adaptation.
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5 minutes
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Duque G, Boersma D, Loza-Diaz G, Hassan S, Suarez H, Geisinger D, Suriyaarachchi P, Sharma A, Demontiero O. Effects of balance training using a virtual-reality system in older fallers. Clin Interv Aging. 2013;8:257-63. doi: 10.2147/CIA.S41453. Epub 2013 Feb 28.
- Shigematsu R, Okura T, Nakagaichi M, Tanaka K, Sakai T, Kitazumi S, Rantanen T. Square-stepping exercise and fall risk factors in older adults: a single-blind, randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):76-82. doi: 10.1093/gerona/63.1.76.
- Shigematsu R, Okura T, Sakai T, Rantanen T. Square-stepping exercise versus strength and balance training for fall risk factors. Aging Clin Exp Res. 2008 Feb;20(1):19-24. doi: 10.1007/BF03324743.
- Fisseha B, Janakiraman B, Yitayeh A, Ravichandran H. Effect of square stepping exercise for older adults to prevent fall and injury related to fall: systematic review and meta-analysis of current evidences. J Exerc Rehabil. 2017 Feb 28;13(1):23-29. doi: 10.12965/jer.1734924.462. eCollection 2017 Feb.
- Moreira Bittar RS, Simoceli L, Bovino Pedalini ME, Bottino MA. The treatment of diseases related to balance disorders in the elderly and the effectiveness of vestibular rehabilitation. Braz J Otorhinolaryngol. 2007 May-Jun;73(3):295-8. doi: 10.1016/s1808-8694(15)30071-9.
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)
2018년 12월 31일
기본 완료 (실제)
2019년 8월 1일
연구 완료 (실제)
2020년 1월 1일
연구 등록 날짜
최초 제출
2019년 7월 12일
QC 기준을 충족하는 최초 제출
2019년 7월 26일
처음 게시됨 (실제)
2019년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 1월 14일
마지막으로 확인됨
2020년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FALL AND SQUARE STEP EXERCİSE
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. .
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