Augmenting Ankle Plantarflexor Function in Cerebral Palsy
ConditionCerebral Palsy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age8-21
SponsorNorthern Arizona University
About this trial
The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility assessed four- and twelve-weeks post intervention compared to standard physical therapy and standard gait training. The second specific aim is to determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP. The primary hypothesis for the second aim is that adaptive ankle assistance will result in significantly greater capacity and performance during the six-minute-walk-test and graded treadmill and stair stepping protocols compared to walking with ankle foot orthoses and walking with just shoes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction.
Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III).
At least 20° of passive plantar-flexion range of motion.
Disqualifiers
Concurrent treatment other than those assigned during the study.
A condition other than CP that would affect safe participation.
Surgical intervention within 6 months of participation.
Trial design
Design model
Parallel
Treatments tested in this trial
Biomotum Spark: Robotic ankle assistance
DeviceA lightweight assistive wearable ankle robotic device.
Biomotum Spark: Robotic ankle resistance
DeviceA lightweight resistive wearable ankle robotic device.
Standard gait training
Other interventionStandard gait training without a device.
Ankle foot orthosis
DeviceStandard ankle foot orthosis
Standard physical therapy
Other interventionPhysical therapy without a device.
Standard walking
Other interventionWalking without a device
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Device resisted gait training (treatment)Experimental treatment 1 intervention
Group B: Standard gait training (control)Experimental treatment 1 intervention
Group C: Comparison to Standard PT (within subjects control)Experimental treatment 1 intervention
Group D: Device assisted ambulationExperimental treatment 1 intervention
Group E: Passive brace assisted ambulationExperimental treatment 1 intervention
Group F: No ankle aid ambulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Time frame
Immediately after the intervention2
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Time frame
2 weeks after the intervention3
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Time frame
12 weeks after the intervention4
Change in similarity of plantarflexor muscle activity
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Time frame
Immediately after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northern Arizona University
Lead sponsor
Gillette Children's Specialty Healthcare
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov