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 effect mobility outcomes.
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 5-azacitidine (AZA), an FDA-approved drug for pediatric oncology, or a placebo. Research in muscle fibers has shown that AZA aids in muscle growth and regeneration. The use of AZA in this study is an off-label application employed together with the smart AFO intervention to investigate the impact of targeting both muscular and mechanical deficits related to CP. This project will also collect blood samples of participants to investigate the potential genetic and epigenetic correlations with the severity and trajectory of musculoskeletal impairments and with responses to the smart AFO and AZA interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
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.
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.
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.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
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.
Time frame: Baseline to Follow-Up, approximately 13 weeks
10 Meter Walking Test
Participants will walk 10 meters to assess gait speed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Follow-Up, approximately 13 weeks
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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.
Time frame: 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.
Time frame: Baseline to Follow-Up, approximately 13 weeks