Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy

Summary

The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests.

After completing the baseline tests, the participants with CP will undergo the therapeutic gait training using either traditional physical therapy or utilizing a robotic exoskeleton. After completing all of the therapeutic gait training sessions, the participants will repeat the same assessments that were completed at baseline. The two groups will be compared based on the assessments for therapeutic outcomes.

Conditions

• Cerebral Palsy

Interventions

BEHAVIORAL

Robotic Exoskeleton Gait Therapy

The training protocol will consist of 24-treatment sessions that will be performed 3 times-a-week for an 8-week period. All therapeutic exercises will be performed under the direction of a licensed physical therapist. Any sessions missed will be added on to the 8-week period. Each intervention session will be completed in a 60-minute sessions with rests as needed. The key components of the therapy will include: 1) optimally challenging activities of variable intensity that emphasize motor planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints, 2) task specific overground movements that promote building a repertoire of mobility strategies that can be utilized in the community, and 3) motor tasks requiring active control that increase participant therapeutic engagement. An overhead body weight support system or a gait-belt may be used for some individuals during the robotic exoskeleton gait training blocks.

BEHAVIORAL

Physical Therapy

The training protocol will consist of 24-treatment sessions that will be performed 3 times-a-week for an 8-week period. All therapeutic exercises will be performed under the direction of a licensed pediatric physical therapist. Any sessions missed will be added on to the 8-week period. Each intervention session will consist of over-ground gait activities that will be completed in a 60 minute session with rests as needed. The key ingredients of the therapy will include: 1) activities of adequate intensity that promote gait adaptation and gait speed sustainment, 2) exploratory activities that enhance the somatosensory experience through rich/novel movement, and 3) optimally challenging activities that emphasize planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints. An overhead body weight support system or a gait-belt may be used for some individuals during the gait training blocks

Sponsors & Collaborators

• Father Flanagan's Boys' Home

  lead OTHER

Principal Investigators

• Max J Kurz, PhD · Father Flanagan's Boys' Home

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-02

Primary Completion

2025-01-01

Completion

2026-01-01

Countries

• United States

Study Locations