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임상시험 NCT07434492은(는) 뇌성마비에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy 2상 60 자택 무작위 배정
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 NCT07434492은(는) 기타을(를) 알아보기 위한 연구입니다. 이 연구는 뇌성마비에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 3월 1일부터 가능하며, 60명의 참여자를 모집할 예정입니다. Shirley Ryan AbilityLab이(가) 진행하는 이 연구는 2030년 8월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 25일에 갱신되었습니다.
간단한 개요
This is an intervention study to investigate the impact of a smart ankle-foot orthosis (AFO) on mobility outcomes in children with Cerebral Palsy. Participants will complete a three phase protocol including 6-weeks of at home training with the smart AFO. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the smart AFO to further...더 보기
상세한 설명
The goal of this project is to investigate the impact of the Biomotum Ambulo ankle-foot orthosis on gait outcomes in children with Cerebral Palsy. The device will be tested for its orthotic benefits when providing mechanical ankle assistance and its therapeutic benefits when providing progressive, resistance-based ankle exercise. Through a 1:1 randomization, a subset of opt-in participants will also receive a dose of...더 보기
공식 제목
Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy
질환명
뇌성마비기타 연구 식별자
- STU00225131
NCT 번호
실제 연구 시작일
2026-03-01
최신 업데이트 게시
2026-02-25
예상 연구 완료일
2030-08-31
계획된 등록 인원
60
연구종류
중재연구
단계/상
2상
상태
대상자모집전
키워드
Pediatric
주요 목적
기타
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Smart AFO & Home Intervention Training + 5-Azacitidine Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.
Each session will involve:
1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT)
2. Monito...더 보기 | Smart Ankle-Foot Orthosis The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait. 5-Azacitidine A subset of opt-in participants will receive a single dose (75mg/m²) of 5-Azacitidine (AZA), an FDA-approved drug for pediatric oncology. A registered nurse will deliver a single subcutaneous injection at midpoint. |
활성 대조군Smart AFO & Home Intervention Training + Mannitol (Placebo) Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.
Each session will involve:
1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT)
2. Monito...더 보기 | Smart Ankle-Foot Orthosis The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait. 위약 A subset of opt in participants will receive a single dose (75mg/m²) of Mannitol (placebo). A registered nurse will deliver a single subcutaneous injection at midpoint. |
활성 대조군Smart AFO & Home Intervention Training Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.
Each session will involve:
1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT)
2. Monito...더 보기 | Smart Ankle-Foot Orthosis The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
6 Minute Walking Test | Participants will complete a 6 minute walking test to measure the total distance they can walk in a 6 minute period. | Baseline to Follow-Up, approximately 13 weeks |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
10 Meter Walking Test | Participants will walk 10 meters to assess gait speed. | Baseline to Follow-Up, approximately 13 weeks |
Gross Motor Function Measure 88 (GMFM-88) | GMFM-88 will be used to measure changes in gross motor function over time. | Baseline to Follow-Up, approximately 13 weeks |
Selective Control Assessment of the Lower Extremity (SCALE) | The SCALE is a clinical assessment tool used to evaluate selective voluntary motor control of the lower limbs. | Baseline to Post-Intervention, approximately 7 weeks |
Pediatric Berg Balance Scale (BBS) | The Pediatric BBS will be used to assess static balance and fall risk. | Baseline to Follow-Up, approximately 13 weeks |
Modified Tardieu Scale (MTS) | Modified Tardieu Scale will be completed to assess the muscle's response to stretch at given velocities. | Baseline to Follow-Up, approximately 13 weeks |
Cerebral Palsy Questionnaire (CPCHILD) | CPCHILD will be administered to capture the child's and family's perspective on well-being and participation. | Baseline to Follow-Up, approximately 13 weeks |
Wong-Baker FACES Pain Rating Scale | The Wong-Baker FACES Pain Rating Scale will be used for children to self-report their level of pain. | Baseline to Follow-Up, approximately 13 weeks |
Pictorial Children's Effort Rating Table (PCERT) | The PCERT will be used for children to self-assess and communicate their perceived exertion during physical activity or exercise. | Baseline to Follow-Up, approximately 13 weeks |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
8 Years
참여 가능한 성별
전체
- Diagnosis of cerebral palsy classified as Gross Motor Function Classification System (GMFCS) levels I to III
- Between 8 and 17 years and 8 months of age at the time of enrollment/consent. Participants that will turn 18 during the course of the study will not be included as pausing the at-home protocol until re-consenting is possible could interfere with intervention results.
- Stable medical condition as determined by the investigator.
- Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the PI.
- Height/weight/BMI between the 5th - 95th percentile of children with cerebral palsy
- Able to walk for at least 6 minutes (assisted or unassisted)
- Able to understand and follow simple directions
- Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
- At least 20 degrees of passive ankle plantar flexion range of motion
- Physician approval for participation
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees
- Immunodeficiency or hematologic condition
- Allergy to AZA or mannitol
- Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5
- Pregnancy
- Orthopedic surgery on the lower limbs completed in the prior 12 months
- New implanted device (e.g., baclofen pump) and/or active intrathecal medication titration that may affect muscle spasticity
- Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the study physician
- Severe osteoporosis unless given approval by the study physician
- Current enrollment in a conflicting research study
- Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician
Shirley Ryan AbilityLab연구 책임자
Megan O'Brien, 책임연구자, Associate Director, Technology & Innovation, Shirley Ryan AbilityLab
연구 대표 연락처
연락처: Audrey Wiesner, BS, 3122388435, [email protected]
연락처: Jacklyn Stoller, PT, DPT, 3122387620, [email protected]
1 1개국에 임상시험 장소
Illinois
Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States