Augmenting Ankle Plantarflexor Function in Cerebral Palsy

NCT05154253 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 1R01HD107277
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Gait; Rehabilitation

Outcome Measures

Primary Outcomes (32)

• Change in preferred walking speed

  Participant's preferred walking speed compared after to before the intervention

  Immediately after the intervention

• Change in preferred walking speed

  Participant's preferred walking speed compared after to before the intervention

  2 weeks after the intervention

• Change in preferred walking speed

  Participant's preferred walking speed compared after to before the intervention

  12 weeks after the intervention

• 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.

  Immediately after the intervention

• 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.

  2 weeks after the intervention

• 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.

  12 weeks after the intervention

• Change in 6-minute-walk-test distance

  Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.

  Immediately after the intervention

• Change in 6-minute-walk-test distance

  Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.

  2 weeks after the intervention

• Change in 6-minute-walk-test distance

  Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.

  12 weeks after the intervention

• Change in variance in muscle activity

  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.

  Immediately after the intervention

• Change in variance in muscle activity

  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.

  2 weeks after the intervention

• Change in variance in muscle activity

  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.

  12 weeks after the intervention

• Change in stride length

  Participant stride length during walking. Longer stride length is desired.

  Immediately after the intervention

• Change in stride length

  Participant stride length during walking. Longer stride length is desired.

  2 weeks after the intervention

• Change in stride length

  Participant stride length during walking. Longer stride length is desired.

  12 weeks after the intervention

• Change in stride-to-stride variability stride length

  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.

  Immediately after the intervention

• Change in stride-to-stride variability stride length

  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.

  2 weeks after the intervention

• Change in stride-to-stride variability stride length

  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.

  12 weeks after the intervention

• Change in walking posture

  Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).

  Immediately after the intervention

• Change in walking posture

  Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).

  2 weeks after the intervention

• Change in walking posture

  Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).

  12 weeks after the intervention

• Change in Gross Motor Function Measure-66 sec. D&E

  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.

  Immediately after the intervention

• Change in Gross Motor Function Measure-66 sec. D&E

  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.

  2 weeks after the intervention

• Change in Gross Motor Function Measure-66 sec. D&E

  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.

  12 weeks after the intervention

• Change in plantar-flexor strength

  Plantar-flexor muscle strength measured via hand-held dynamometry.

  Immediately after the intervention

• Change in plantar-flexor strength

  Plantar-flexor muscle strength measured via hand-held dynamometry.

  2 weeks after the intervention

• Change in plantar-flexor strength

  Plantar-flexor muscle strength measured via hand-held dynamometry.

  12 weeks after the intervention

• Distance traveled

  Distance traveled during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols.

  1 day

• Metabolic cost of transport from indirect calorimetry

  Metabolic cost estimated from a wearable indirect calorimetry system during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols

  1 day

• Subject perceived exertion

  Subject perceived exertion (validated pictorial pediatric exertion scale). The scale is from 1-10, where a higher number indicates more effort.

  1 day

• Average muscle activity

  Average stance-phase plantar flexor muscle activity assessed through surface electromyography of the soleus muscle.

  1 day

• Heart Rate

  Average heart rate during each testing condition measured via chest-mounted heart rate monitor.

  1 day

Study Arms (6)

Device resisted gait training (treatment)

EXPERIMENTAL

We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.

Device: Biomotum Spark: Robotic ankle resistance

Standard gait training (control)

EXPERIMENTAL

We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.

Other: Standard gait training

Comparison to Standard PT (within subjects control)

EXPERIMENTAL

We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.

Other: Standard physical therapy

Device assisted ambulation

EXPERIMENTAL

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Device: Biomotum Spark: Robotic ankle assistance

Passive brace assisted ambulation

EXPERIMENTAL

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Device: Ankle foot orthosis

No ankle aid ambulation

EXPERIMENTAL

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Other: Standard walking

Interventions

Biomotum Spark: Robotic ankle assistance DEVICE

A lightweight assistive wearable ankle robotic device.

Device assisted ambulation

Biomotum Spark: Robotic ankle resistance DEVICE

A lightweight resistive wearable ankle robotic device.

Device resisted gait training (treatment)

Standard gait training OTHER

Standard gait training without a device.

Standard gait training (control)

Ankle foot orthosis DEVICE

Standard ankle foot orthosis

Passive brace assisted ambulation

Standard physical therapy OTHER

Physical therapy without a device.

Comparison to Standard PT (within subjects control)

Standard walking OTHER

Walking without a device

No ankle aid ambulation

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Arizona University: lead
• Gillette Children's Specialty Healthcare: collaborator
• University of Washington: collaborator

Study Sites (1)

Gillette Children's Specialty Healthcare

Minneapolis, Minnesota, 55101, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Zach F Lerner, PhD

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zach Lerner, PhD

CONTACT

928-523-1787; zachary.lerner@nau.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 13, 2021
• Study Start: February 1, 2023
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)