Augmenting Ankle Plantarflexor Function in Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomotum Spark: Robotic ankle assistance, Biomotum Spark: Robotic ankle resistance, Standard gait training, Ankle foot orthosis.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 8 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy
Overview
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.
Detailed description
A child's ability to walk effectively is essential to their physical health and general well-being. Unfortunately, many children with cerebral palsy (CP), the most common cause of pediatric physical disability, have difficulty walking and completing higher-intensity ambulatory tasks. This leads to children with CP engaging in levels of habitual physical activity that are well below guidelines and those of children without disabilities, which in turn contributes to many secondary conditions, including metabolic dysfunction and cardiovascular disease. There is broad clinical consensus that plantarflexor dysfunction is a primary contributor to slow, inefficient, and crouched walking patterns in CP; individuals with CP need more effective treatments and mobility aids for plantarflexor dysfunction. To meet this need, this proposal aims to evaluate a holistic strategy to address impaired mobility from plantarflexor dysfunction in CP using a lightweight, dual-mode (assistive or resistive) wearable robotic device. This strategy combines two complementary techniques: (1) targeted ankle resistance for neuromuscular gait training that provides precision therapy to elicit long-term improvements in ankle muscle function, and (2) adaptive ankle assistance to make walking easier during sustained, high-intensity, or challenging tasks.
Aim 1: Quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with CP Approach - Repeated Measures (RM) and randomized controlled trial: The investigators will compare functional outcomes following targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard physical therapy (RM) and vs. dose-matched standard treadmill training (randomized controlled trial). Primary Hypothesis: 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 the control conditions.
Aim 2: Determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP Approach - Repeated Measures: The investigators will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid) during (a) 6-minute-walk-test, (b) extended-duration over-ground walking (sustained), (c) graded treadmill (high-intensity), and (d) stair-stepping (challenging) protocols. Task capacity and performance will be measured by duration, metabolic cost, speed, and stride length, as applicable. Primary Hypothesis: Adaptive ankle assistance will result in significantly greater capacity and performance compared to the control conditions.
Interventions
- Device Biomotum Spark: Robotic ankle assistance
A lightweight assistive wearable ankle robotic device. - Device Biomotum Spark: Robotic ankle resistance
A lightweight resistive wearable ankle robotic device. - Other Standard gait training
Standard gait training without a device. - Device Ankle foot orthosis
Standard ankle foot orthosis - Other Standard physical therapy
Physical therapy without a device. - Other Standard walking
Walking without a device
Primary outcome measures
- Change in preferred walking speed [Time frame: Immediately after the intervention]
- Change in preferred walking speed [Time frame: 2 weeks after the intervention]
- Change in preferred walking speed [Time frame: 12 weeks after the intervention]
- Change in similarity of plantarflexor muscle activity [Time frame: Immediately after the intervention]
- Change in similarity of plantarflexor muscle activity [Time frame: 2 weeks after the intervention]
- Change in similarity of plantarflexor muscle activity [Time frame: 12 weeks after the intervention]
- Change in 6-minute-walk-test distance [Time frame: Immediately after the intervention]
- Change in 6-minute-walk-test distance [Time frame: 2 weeks after the intervention]
- Change in 6-minute-walk-test distance [Time frame: 12 weeks after the intervention]
- Change in variance in muscle activity [Time frame: Immediately after the intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Gillette Children's Specialty Healthcare — Minneapolis
Identifiers
NCT: NCT05154253 · 1R01HD107277