Augmenting Ankle Plantarflexor Function in Cerebral Palsy

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

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

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Northern Arizona University

  lead OTHER

Principal Investigators

• Zach F Lerner, PhD · Northern Arizona University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2026-09-14

Completion

2026-09-25

FDA Device

Yes

Countries

• United States

Study Locations