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Effect of Plantar Vibration on Static and Dynamic Balance

2021년 6월 30일 업데이트: Birol Önal, Kırıkkale University

Effect of Plantar Vibration on the Static and Dynamic Balance in Stroke Patients

The aim of this study is to have a positive effect on the static and dynamic balance of vibration applied to the foot base in stroke patients.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the education group and the control group. Patients will be taken to the control and study group respectively in order of arrival. If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. Patients in the control group will be given routine conventional physiotherapy in 4-week and 60-minute sessions. The training group will be given routine conventional physiotherapy in 4-week and 45-minute sessions.In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy. Individuals before; age, gender, marital status, nutritional characteristics, habits, smoking and alcohol, auxiliary devices, background information, family history, educational status, social security, previous or current occupation, frequency of fall, cause of fall and drugs used will be questioned. Static and dynamic equilibrium parameters will be evaluated at the beginning of the study and at the end of the 4th week.

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

  • 칠면조
      • Kırıkkale, 칠면조, 71000
        • Kırıkkale University

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

45년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 45-70 years of age stroke areas
  • Cognitive and non-communication problems
  • Volunteer to join the work
  • Those with less than 150 kilos
  • Can walk 10 meters independently (with assistive device if available)
  • Patients with a maximum level of 2-3 spasticity according to the Modified Ashworth Scale
  • Patients at least 8 weeks after stroke diagnosis

Exclusion Criteria:

  • People who are not stable due to vital signs
  • Those with coronary heart disease
  • Open wounds under the soles of the feet
  • Being spastic at the level that will block the base touch
  • Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
  • 20 seconds independent standing
  • Mini Mental Test score below 24
  • Multiple sclerosis, Parkinson's disease, etc.
  • Those with vision problems
  • Patients with thoracolumbar surgery
  • Patients with spinal canal stenosis

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Plantar Vibration Group
Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities. In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
다른: Plantar Vibration Group
Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities. In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
활성 비교기: Control Group
Patients in the control group will be received 60-minute conventional pysiotherapy session for 5-days in a week, over 4-week. Each physiotherapy session will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
다른: Control Group
Patients in control group will be received 60-minute conventional physiotherapy session for 5-days in a week, over 4-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mini-Mental State Test
기간: 15 minute
It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24.
15 minute
Time Up and Go Test
기간: 5 minute
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
5 minute
Berg Balance Scale
기간: 15 minute
It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
15 minute
Trunk Impairment Scale
기간: 10 minute
Evaluate the motor loss in trunk after stroke.It is a scale consisting of 17 items.3 items assess the static sitting balance, dynamic balance with 10 items, coordination with 4 items.The score is 0-23.The highest score is considered the best performance.
10 minute
Functional Reach Test
기간: 5 minute
Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated.
5 minute
10 Meter Walk Tests
기간: 3 minute
Walking speed are measure by timing subjects over 10 meters with a stopwatch. To avoid the effects of acceleration and deceleration, measurements take over the middle 10 meters of a 14-meter walkway. It is repeated 2 times.
3 minute

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Kırıkkale University

수사관

  • 수석 연구원: Birol Onal, Kırıkkale University

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

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 26일

기본 완료 (실제)

2019년 6월 20일

연구 완료 (실제)

2019년 7월 25일

연구 등록 날짜

최초 제출

2018년 12월 18일

QC 기준을 충족하는 최초 제출

2018년 12월 20일

처음 게시됨 (실제)

2018년 12월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 6월 30일

마지막으로 확인됨

2021년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • strokeandvibration

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

Plantar Vibration Group에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Brazil

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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