- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07651111
Action Observation Therapy in Children With Spastic Diplegia (AOT/CP)
Effect of Live Versus Video Action Observation Training on Balance and Gait in Children With Spastic Diplegia
연구 개요
상태
정황
상세 설명
Children with spastic diplegic often face difficulties with balance and walking, affecting their independence and quality of life. Because of the impact of reduced gait speed and other gait abnormalities on their participation and quality of life, the main focus of physical therapy interventions is to improve balance and gait of children with cerebral palsy (CP).
Action observation training is a developing rehabilitation based on mirror neurons that activate when one performs movements or observes the movements of others. It is applied to improve motor skills and learning in athletes, healthy people, and patients with motor disorders.
Although many studies have focused on the application of action observation training (AOT), especially in improving upper limb function in individuals with stroke or children with CP, there is still a lack of sufficient research examining its effects on spasticity, gross motor abilities, balance, and gait in children with CP.
There is one study comparing the effects of live and video forms of AOT on upper limb function in children with hemiparetic CP. The researchers found that live AOT was more effective than video AOT in improving upper limb performance.
To our knowledge, there are no previous studies that compare the effect of live and video forms of AOT on balance and gait in children with spastic diplegia. Addressing this gap may provide valuable insights into the optimal mode of AOT delivery for enhancing balance and gait.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Esraa Elsayed Ali Elkiky, M.Sc
- 전화번호: +20 10 92002696
- 이메일: esraa.elkiky@gmail.com
연구 연락처 백업
- 이름: Mai Elsayed Abbass, PhD
연구 장소
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Giza, 이집트, 12511
- Outpatient clinic of the Faculty of physical therapy, Cairo University
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연락하다:
- Esraa Elsayed Ali Elkiky, M.Sc
- 전화번호: +20 10 92002696
- 이메일: esraa.elkiky@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children of diplegia who walk by a crouch gait.
- The age of the selected children will range from 4 to 7 years old.
- Degree of spasticity will range from 1 to 1+, according to modified Ashworth scale (MAS).
- They will be selected as Level II according to Gross motor function classification system (GMFCS).
- They will be able to understand the tasks and researchers' instructions.
- Their heights are not less than 1 meter to be able to see the screen of the Biodex balance system.
Exclusion Criteria:
- Visual or auditory impairments.
- Vestibular impairments.
- Fixed deformities of the upper, lower limbs, and the spine.
- Botulinum toxin (Botox) injection for the last six months.
- Orthopedic surgeries in the last six months.
공부 계획
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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활성 비교기: A selected physical therapy program
Fifteen children will receive one hour of a selected physical therapy program, three times per week for 3 months.
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Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months.
The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs.
The intervention aims to improve balance, mobility, coordination, and functional performance.
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실험적: A selected physical therapy program + Live action observation training (AOT)
Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of live AOT, three times per week for 3 months.
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Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months.
The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs.
The intervention aims to improve balance, mobility, coordination, and functional performance.
Participants will receive live AOT for 30 minutes, 3 times per week, for 3 months.
Each task will involve 3 minutes of observing the therapist performing the activity, followed by 3 minutes of verbal guidance and 3 minutes of task execution by the child.
A 1-minute rest period will be provided between tasks.
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실험적: A selected physical therapy program + Video action observation training (AOT)
Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of video AOT, three times per week for 3 months.
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Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months.
The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs.
The intervention aims to improve balance, mobility, coordination, and functional performance.
Participants will receive video-based AOT for 30 minutes, 3 times per week, for 3 months.
They will observe task demonstrations presented on a computer screen from multiple viewing angles, followed by guided practice and task performance, similar to the live AOT protocol.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Stability Index (OSI)
기간: 3 months
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It will be assessed using the Biodex Balance System.
Participants will stand on a dynamic platform at stability level 5 for three 30-second trials.
The Overall Stability Index (OSI) will be recorded as a measure of postural stability in all directions.
Lower OSI values indicate better balance control and greater postural stability.
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3 months
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Anteroposterior Stability Index (APSI)
기간: 3 months
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It will be measured using the Biodex Balance System during dynamic balance testing.
APSI reflects the participant's ability to maintain balance in the forward and backward directions.
Lower APSI scores indicate improved anteroposterior postural control.
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3 months
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Mediolateral Stability Index (MLSI)
기간: 3 months
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It will be assessed using the Biodex Balance System.
MLSI evaluates the participant's ability to control balance in the side-to-side direction during dynamic standing.
Lower MLSI values indicate better mediolateral stability and balance performance.
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hip Flexion Angle
기간: 3 months
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It will be assessed using Kinovea motion analysis software during gait.
Reflective markers will be placed on anatomical landmarks, and participants will walk at a self-selected speed while being recorded with a high-definition camera.
Hip flexion will be measured during the late swing phase, corresponding to peak hip flexion.
Greater hip flexion angles toward normative values will indicate improved gait kinematics.
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3 months
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Knee Flexion Angle
기간: 3 months
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It will be evaluated using Kinovea software from recorded gait videos.
Anatomical markers will be positioned on the greater trochanter, lateral femoral condyle, and lateral malleolus.
Knee flexion will be measured during the terminal stance phase.
Changes toward normal knee kinematics will be considered indicative of gait improvement.
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3 months
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Ankle Dorsiflexion Angle
기간: 3 months
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It will be measured using Kinovea software during gait analysis.
Reflective markers placed on the lower limb and foot will be used to calculate ankle joint kinematics.
Ankle dorsiflexion will be assessed at initial contact.
Increased dorsiflexion toward normal gait values will indicate improved gait performance.
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3 months
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Eman Ibrahem El-Hadidy, PhD, Professor, Cairo university
- 연구 책임자: Mai Elsayed Abbass, PhD, Ass. Professor, Cairo university
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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. .
경련성 마비에 대한 임상 시험
-
Indiana UniversityNational Institutes of Health (NIH)모병
A selected physical therapy program에 대한 임상 시험
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Foundation University Islamabad모병
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