Clinical trial NCT05154253: Augmenting Ankle Plantarflexor Function in Cerebral Palsy
Official title: Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cerebral Palsy
Keywords: Gait
Rehabilitation
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: Gillette Children's Specialty Healthcare
name: University of Washington
First posted: 2021-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Change in preferred walking speed
timeFrame: Immediately after the intervention
measure: Change in preferred walking speed
timeFrame: 2 weeks after the intervention
measure: Change in preferred walking speed
timeFrame: 12 weeks after the intervention
measure: Change in similarity of plantarflexor muscle activity
timeFrame: Immediately after the intervention
measure: Change in similarity of plantarflexor muscle activity
timeFrame: 2 weeks after the intervention
measure: Change in similarity of plantarflexor muscle activity
timeFrame: 12 weeks after the intervention
measure: Change in 6-minute-walk-test distance
timeFrame: Immediately after the intervention
measure: Change in 6-minute-walk-test distance
timeFrame: 2 weeks after the intervention
measure: Change in 6-minute-walk-test distance
timeFrame: 12 weeks after the intervention
measure: Change in variance in muscle activity
timeFrame: Immediately after the intervention
measure: Change in variance in muscle activity
timeFrame: 2 weeks after the intervention
measure: Change in variance in muscle activity
timeFrame: 12 weeks after the intervention
measure: Change in stride length
timeFrame: Immediately after the intervention
measure: Change in stride length
timeFrame: 2 weeks after the intervention
measure: Change in stride length
timeFrame: 12 weeks after the intervention
measure: Change in stride-to-stride variability stride length
timeFrame: Immediately after the intervention
measure: Change in stride-to-stride variability stride length
timeFrame: 2 weeks after the intervention
measure: Change in stride-to-stride variability stride length
timeFrame: 12 weeks after the intervention
measure: Change in walking posture
timeFrame: Immediately after the intervention
measure: Change in walking posture
timeFrame: 2 weeks after the intervention
measure: Change in walking posture
timeFrame: 12 weeks after the intervention
measure: Change in Gross Motor Function Measure-66 sec. D&E
timeFrame: Immediately after the intervention
measure: Change in Gross Motor Function Measure-66 sec. D&E
timeFrame: 2 weeks after the intervention
measure: Change in Gross Motor Function Measure-66 sec. D&E
timeFrame: 12 weeks after the intervention
measure: Change in plantar-flexor strength
timeFrame: Immediately after the intervention
measure: Change in plantar-flexor strength
timeFrame: 2 weeks after the intervention
measure: Change in plantar-flexor strength
timeFrame: 12 weeks after the intervention
measure: Distance traveled
timeFrame: 1 day
measure: Metabolic cost of transport from indirect calorimetry
timeFrame: 1 day
measure: Subject perceived exertion
timeFrame: 1 day
measure: Average muscle activity
timeFrame: 1 day
measure: Heart Rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Northern Arizona University
name: Zach F Lerner, PhD
role: PRINCIPAL_INVESTIGATOR
References: