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임상시험 NCT07253857 (HABIT-ILE)은(는) 뇌성마비, 경직형 뇌성마비에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy (HABIT-ILE) 42 무작위 배정 소아
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07253857 (HABIT-ILE)은(는) 뇌성마비, 경직형 뇌성마비에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 12월 20일에 시작되어 42명의 참여자를 모집하고 있습니다. Lahore University of Biological and Applied Sciences이(가) 진행하며, 2026년 5월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 13일에 갱신되었습니다.
간단한 개요
Cerebral palsy (CP), particularly the spastic diplegic subtype, is characterized by motor impairments such as spasticity and mobility limitations. In addition to motor dysfunction, children with CP often experience cognitive impairments affecting decision-making, problem-solving, working memory, selective attention, and inhibitory control. These non-motor challenges contribute to reduced social interaction and qualit...더 보기
상세한 설명
Cerebral palsy is a group of permanent movement and posture disorder caused by damage to the developing brain typically before, during or after birth. It is one of the most common neurodevelopmental disorder in childhood. Spasticity accounts for the majority of cases (around 92%), followed by dyskinesia, hypotonia, ataxia, and mixed types. Within spastic CP, three subtypes are recognized: diplegia, quadriplegia, and ...더 보기
공식 제목
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
질환명
뇌성마비경직형 뇌성마비출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- HABIT-ILE
- UBAS/ERB/FoRS/25/039 Aleena
NCT 번호
실제 연구 시작일
2025-12-20
최신 업데이트 게시
2026-01-13
예상 연구 완료일
2026-05
계획된 등록 인원
42
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
HABIT-ILE
Intensive motor therapy
Cerebral Palsy
diplegic cerebral palsy with spasticity
Spastic cerebral palsy
Intensive motor therapy
Cerebral Palsy
diplegic cerebral palsy with spasticity
Spastic cerebral palsy
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적GROUP -A HABIT-ILE Therapy Name of intervention : Hand and Arm Bimanual Intensive Therapy Including Lower Extermity Type of intensity; intensive , activity based camp style rehabilitation program The HABIT-ILE therapy sessions will be structured to target both upper and lower limbs divided into three categories. Half of each session will focus on table-based bimanual tasks with postural challenges, performed while sitting on fitness balls or s...더 보기 | GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity Hand Arm Bimanual Intensive Therapy Including Lower Extremity being a task based intensive therapy activities will be structured according to the participants ability to preform it. The intervention incorporates structured bimanual activities that progressively increase in motor complexity, along with functional tasks that necessitate coordinated use of both hands, systematically integrating postural and lower-extrem...더 보기 |
실험적GROUP- B Conventional Physical Therapy The intervention will be delivered five times per week, with each movement repeated three to five times. Sessions will begin at low to moderate intensity and will gradually progress based on patient response. Exercises will include weight-bearing activities such as sit-to-stand transitions to strengthen quadriceps and gluteal muscles, step initiation drills to activate tibialis anterior and gastrocnemius for proper f...더 보기 | GROUP-B , Conventional Physical Therapy Conventional therapy will include stretches of lower extremity following bobath approach and cognitive exercises. |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Gross Motor Function Measure 88 (GMFM-88) | It is a standardized assessment tool designed to evaluate motor function in children with cerebral palsy (CP). It consists of 88 items that measure gross motor abilities across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking, running \& jumping. Each domain is scored on a 4-point ordinal scale where 0 indicates the child does not initiate the movement, 1 reflects initiation with less than 10% completion, 2 represents partial completion between 10% and less than 100%, and 3 denotes full completion of the movement as intended. Higher scores means that the child can move more independently while lower scores show difficulties in movement and point to areas where therapy is needed. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Behavior Rating Inventory Of Executive Function-2 (BRIEF-2) Parent form | It assesses executive function in children, including those with cerebral palsy (CP), measuring impulse control, emotional regulation, and working memory | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
ABILOCO-KIDS-CP | This assessment tool designed to evaluate locomotion ability in children with cerebral palsy | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
ABILHAND-KIDS-CP | it is an assessment tool designed to evaluate manual ability in children with cerebral palsy. It focuses on bimanual activities, measuring the child's ability to perform daily tasks requiring upper limb coordination. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Box and Block Test (BBT) | It is assessment tool for evaluating manual dexterity in individuals with cerebral palsy. It measures gross motor coordination of the upper limbs by assessing the ability to grasp, transport, and release small blocks within a timed period. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
6 Minute Walk Test | It evaluates how far a person can walk in six minutes | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
6 Years
참여 가능한 성별
전체
- Diagnosed with diplegic cerebral palsy
- CP children with manual ability level 1-3 on manual ability classification system
- Participants with gross motor function classification system level ranging from 1-3 will be included in the study.
- With an ability to grasp light objects and lift the more affected arm 15 cm above a table surface.
- Base line cognition level should be 20 or above assessed through mini mental state exam for children (MMC).
- Uncontrolled seizures
- Recent or planned botulinum toxin injections within 6 months
- Any recent orthopedic interventions that may affect motor function
- Visual impairments impeding with treatment protocol
Lahore University of Biological and Applied Sciences연구 대표 연락처
연락처: Aleena Ishfaq, DPT, +92 3324210141, [email protected]
연락처: Aruba Saeed, NMPT, PhD*, +92 3344399403, [email protected]
1 1개국에 임상시험 장소
Punjab Province
Pakistan Society for Rehabilitation of Differently Abled (PSRD), Lahore, Punjab Province, 54660, Pakistan
모집중