Augmenting Ankle Plantarflexor Function in Cerebral Palsy
This study is looking at new ways to help children and young adults with cerebral palsy (CP) walk better. It's testing a lightweight robotic device called Biomotum Spark, which can either help or resist ankle movement. Researchers want to see if using this device for training, or to make walking easier, improves ankle muscle function and walking ability. They will compare it to standard physical therapy, standard gait training (walking practice), and ankle foot orthoses (braces). The study will measure changes in walking speed immediately after the intervention, and again at 2 weeks and 12 weeks later. You may be able to join if you are 8 to 21 years old, have CP affecting your ankles, and can walk at least 30 feet with or without help. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 36 participants. The study aims to compare different interventions for improving walking in individuals with cerebral palsy.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks after the intervention to measure changes in walking speed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Augmenting Ankle Plantarflexor Function in Cerebral Palsy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Zach F Lerner, PhD · PRINCIPAL_INVESTIGATOR · Northern Arizona University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in preferred walking speedImmediately after the intervention
Participant's preferred walking speed compared after to before the intervention
- Change in preferred walking speed2 weeks after the intervention
Participant's preferred walking speed compared after to before the intervention
- Change in preferred walking speed12 weeks after the intervention
Participant's preferred walking speed compared after to before the intervention
- Change in similarity of plantarflexor muscle activityImmediately after the intervention
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.
- Change in similarity of plantarflexor muscle activity2 weeks after the intervention
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.
- Change in similarity of plantarflexor muscle activity12 weeks after the intervention
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.
- Change in 6-minute-walk-test distanceImmediately after the intervention
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
- Change in 6-minute-walk-test distance2 weeks after the intervention
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
- Change in 6-minute-walk-test distance12 weeks after the intervention
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
- Change in variance in muscle activityImmediately after the intervention
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
- Change in variance in muscle activity2 weeks after the intervention
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
- Change in variance in muscle activity12 weeks after the intervention
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
- Change in stride lengthImmediately after the intervention
Participant stride length during walking. Longer stride length is desired.
- Change in stride length2 weeks after the intervention
Participant stride length during walking. Longer stride length is desired.
- Change in stride length12 weeks after the intervention
Participant stride length during walking. Longer stride length is desired.
- Change in stride-to-stride variability stride lengthImmediately after the intervention
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
- Change in stride-to-stride variability stride length2 weeks after the intervention
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
- Change in stride-to-stride variability stride length12 weeks after the intervention
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
- Change in walking postureImmediately after the intervention
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
- Change in walking posture2 weeks after the intervention
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
- Change in walking posture12 weeks after the intervention
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
- Change in Gross Motor Function Measure-66 sec. D&EImmediately after the intervention
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
- Change in Gross Motor Function Measure-66 sec. D&E2 weeks after the intervention
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
- Change in Gross Motor Function Measure-66 sec. D&E12 weeks after the intervention
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
- Change in plantar-flexor strengthImmediately after the intervention
Plantar-flexor muscle strength measured via hand-held dynamometry.
- Change in plantar-flexor strength2 weeks after the intervention
Plantar-flexor muscle strength measured via hand-held dynamometry.
- Change in plantar-flexor strength12 weeks after the intervention
Plantar-flexor muscle strength measured via hand-held dynamometry.
- Distance traveled1 day
Distance traveled during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols.
- Metabolic cost of transport from indirect calorimetry1 day
Metabolic cost estimated from a wearable indirect calorimetry system during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols
- Subject perceived exertion1 day
Subject perceived exertion (validated pictorial pediatric exertion scale). The scale is from 1-10, where a higher number indicates more effort.
- Average muscle activity1 day
Average stance-phase plantar flexor muscle activity assessed through surface electromyography of the soleus muscle.
- Heart Rate1 day
Average heart rate during each testing condition measured via chest-mounted heart rate monitor.