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Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy II期 60 居家 随机化

尚未招募
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07434492旨在研究其他，主要针对脑瘫。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月1日开始，预计招募60名患者。该研究由Shirley Ryan AbilityLab主导，计划于2030年8月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月25日。
简要概括
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...显示更多
详细描述
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...显示更多
官方标题

Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy

疾病
脑瘫
其他研究标识符
  • STU00225131
NCT编号
NCT07434492
实际开始日期
2026-03-01
最近更新发布
2026-02-25
预计完成日期
2030-08-31
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
关键词
Pediatric
主要目的
其他
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Smart 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...显示更多
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.
阳性对照Smart 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...显示更多
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.
安慰剂
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.
阳性对照Smart 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...显示更多
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.
主要终点
结果指标度量标准描述时间框架
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
次要终点
结果指标度量标准描述时间框架
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
参与助手
资格标准

适龄参与研究
儿童
最低年龄要求
8 Years
适龄性别
全部
  • 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 AbilityLab logoShirley Ryan AbilityLab
研究责任方
Megan O'Brien, 主要研究者, Associate Director, Technology & Innovation, Shirley Ryan AbilityLab
研究中心联系人
联系人: Audrey Wiesner, BS, 3122388435, [email protected]
联系人: Jacklyn Stoller, PT, DPT, 3122387620, [email protected]
1 位于 1 个国家/地区的研究中心

Illinois

Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States