- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04136678
The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy (CP)
The aim of this study was to investigate the effect of treadmill back walking training on balance and function in cerebral palsy.
In our study, scientific data will be prepared by clinical measurement tools in order to determine whether there is balance and walking effect of easy and practicable treadmill back walking training in the clinical setting in Cerebral Palsy.
연구 개요
상세 설명
Measurements will be made at baseline and after each 8 weeks of physiotherapy program, the results will be compared.
30 minutes of the physiotherapy session, which we will apply for 2 days and 45 minutes; in the prone, supine, crawling and above knee positions; They will take physiotherapy training based on neurodevelopmental therapy consisting of fine motor activities, standing up, weight transfer, stretching, strengthening and balance exercises with mat activities such as rotation, weight transfer, sitting.
- Term: After the first measurements, the participants will take 8 minutes, 2 days a week, the regular physiotherapy session based on 30 minutes Neurodevelopmental Therapy as described above, as well as 15 minutes conventional walking training, then the measurements will be repeated.
- Term: After the second measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on 30 minutes of Neurodevelopmental Therapy as described above, as well as 15 minutes of treadmill back walking training, then the measurements will be repeated.
- Term: After the third measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on the 30 minute Neurodevelopmental Therapy described above, as well as the 15-minute treadmill walking forward training, then the measurements will be repeated.
Statistical method (s) to be used: In the analysis of the results to be obtained in our study, SPS statistics 22.0 version of SPSS statistical package will be used under the Windows operating system Statistical Package for Social Sciences (SPSS). Descriptive statistical information will be shown as arithmetic mean ± Standard Deviation (x statistical ± Ss) or percentage (%) and the level of statistical significance will be considered as p≤0.05.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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İ̇stanbul, 칠면조, (535) 020-6774
- Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
- Classes classified as Level I and II by Gross Motor Function Classification System (GMFCS),
- Lower extremity spasticity classified as 1st and 2nd degree according to Modified Modified Ashworth Scale,
- To understand and apply verbal commands and instructions.
- Volunteer to participate in the study,
- Read and approve the informed consent form.
Exclusion Criteria:
- Active epileptic seizures
- Those with visual or auditory defects,
- Those with fixed deformities in the lower extremities,
- Patients with a history of surgery in the lower extremity musculoskeletal system in the last 6 months
- Injection of Botulinum Toxin (BOTOX) for lower extremity within the last 6 months Spasticity drug users,
- Those with mental and cognitive problems will be excluded from the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: treadmill back walking training
15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training
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15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Pediatric Balance Scale
기간: 8 weeks
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It can be considered as a simple, valid scale for studying functional balance capacity in children with spastic SP (Yi 2012).
Pediatric Berg Balance Scale (PBBS) will be used to evaluate the functional balance of daily living activities.
Higher scores mean a better outcome.
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8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Rivermead Visual Gait Assessment
기간: 8 weeks
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RVGA allows rapid assessment and documentation of gait disturbances without equipment in the clinic and demonstration of clinical changes (Lord, et al. 1998).
Visual parameters of walking in our study will be evaluated by The Rivermead Visual Gait Assessment (RVGA).
Higher scores mean a worse outcome.
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8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: H D Doğan, Pt, Istanbul Medipol University Hospital
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. .
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