Augmenting Ankle Plantarflexor Function in Cerebral Palsy

NCT ID: NCT05154253

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-09-25

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device resisted gait training (treatment)

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.

Group Type: EXPERIMENTAL

Biomotum Spark: Robotic ankle resistance

Intervention Type: DEVICE

A lightweight resistive wearable ankle robotic device.

Standard gait training (control)

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.

Group Type: EXPERIMENTAL

Standard gait training

Intervention Type: OTHER

Standard gait training without a device.

Comparison to Standard PT (within subjects control)

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

Group Type: EXPERIMENTAL

Standard physical therapy

Intervention Type: OTHER

Physical therapy without a device.

Device assisted ambulation

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

Group Type: EXPERIMENTAL

Biomotum Spark: Robotic ankle assistance

Intervention Type: DEVICE

A lightweight assistive wearable ankle robotic device.

Passive brace assisted ambulation

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

Group Type: EXPERIMENTAL

Ankle foot orthosis

Intervention Type: DEVICE

Standard ankle foot orthosis

No ankle aid ambulation

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

Group Type: EXPERIMENTAL

Standard walking

Intervention Type: OTHER

Walking without a device

Interventions

Biomotum Spark: Robotic ankle assistance

A lightweight assistive wearable ankle robotic device.

Intervention Type: DEVICE

Biomotum Spark: Robotic ankle resistance

A lightweight resistive wearable ankle robotic device.

Intervention Type: DEVICE

Standard gait training

Standard gait training without a device.

Intervention Type: OTHER

Ankle foot orthosis

Standard ankle foot orthosis

Intervention Type: DEVICE

Standard physical therapy

Physical therapy without a device.

Intervention Type: OTHER

Standard walking

Walking without a device

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gillette Children's Specialty Healthcare

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zach F Lerner, PhD

Role: PRINCIPAL_INVESTIGATOR

Northern Arizona University

Locations

Gillette Children's Specialty Healthcare

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zach Lerner, PhD

Role: CONTACT

zachary.lerner@nau.edu

928-523-1787

Facility Contacts

Mike Schwartz, PhD

Role: primary

MSchwartz@gillettechildrens.com

651-229-3929

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HD107277

Identifier Type: NIH

Identifier Source: org_study_id

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