Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy

NCT05158218 | Active Not Recruiting

• 1 other identifier: 21-12-XP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebral Palsy; Gait Therapy; Mobility; Robotic Exoskeleton

Outcome Measures

Primary Outcomes (9)

• Change in Mobility Test Time

  The participant will be asked to perform a series of timed (in seconds) 10-meter walking tasks.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Time for Community Ambulation

  The participants will walk along a 400 meter course laid out on the Boys Town campus that incorporates uphill/downhill grades, stairs, curbs, grass and uneven surfaces. The time (in seconds) to complete the course will be used as an outcome variable.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Time for "Timed Up and Go"

  The participant will start the test by sitting on a bench. The time (in seconds) it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return back to sitting on the bench will be the outcome measure.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Selective Control Assessment of the Lower Extremity

  This is a clinical assessment where the participant is asked to isolate and move the lower extremity joints. The examiner grades the amount of movement and the ability of the participant to isolate the control. A grade of 0 indicates the participant cannot move the joint, 1 indicates the participant can move the joint but it is impaired, and 2 indicates normal movement of the joint.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Level of Spasticity

  Modified Ashworth: This is a clinical assessment where the therapist passively moves the participant's joints and rates the level of spasticity. Scores range from 0-5, where 0 indicates no tone, 5 indicates rigidity.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Isolation of Movement

  This is a clinical assessment where the participant is asked to isolate and move the lower extremity joints. The examiner grades the amount of movement and the ability of the participant to isolate the control. A grade of 0 indicates the participant cannot move the joint, 1 indicates the participant can move the joint but it is impaired, and 2 indicates normal movement of the joint.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Brain Activity in Sensory Cortices

  Magnetoencephalogram (MEG) or electroencephalogram (EEG) scan: The frequency bands of interest include theta (4-8 Hz), alpha (8-12 Hz), beta(15-30 Hz) and gamma (\>30 Hz).

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Motor Response

  Percutaneous electrical stimulations of the femoral nerve applied via an anode that is positioned on the patella and a cathode that is positioned on the popliteal fossa will be applied to the right leg. A wireless surface EMG sensor positioned on the soleus will measure the motor response. The muscular (M-wave) will be assessed while resting and walking.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Change in Hoffmann Reflex

  Percutaneous electrical stimulations of the femoral nerve applied via an anode that is positioned on the patella and a cathode that is positioned on the popliteal fossa will be applied to the right leg. A wireless surface EMG sensor positioned on the soleus will measure the Hoffmann reflex. The spinal reflexes (H-wave) will be assessed while resting and walking.

  Baseline (CP and Neurotypical) and 8 weeks (CP)

Secondary Outcomes (11)

• Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Cognitive related changes induced via physical therapy - D2 - Test of Attention

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Cognitive related changes induced via physical therapy - Trail Making A+B

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult

  Baseline (CP and Neurotypical) and 8 weeks (CP)

• Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult

  Baseline (CP and Neurotypical) and 8 weeks (CP)

Study Arms (2)

Cerebral Palsy Youth/Young Adults Physical Therapy

ACTIVE COMPARATOR

Baseline and 8 week assessments; 8 week gait therapy

Behavioral: Physical Therapy

Cerebral Palsy Youth/Young Adults Robotic Exoskeleton

EXPERIMENTAL

Baseline and 8 week assessments; 8 week gait therapy using robotic exoskeleton

Behavioral: Robotic Exoskeleton Gait Therapy

Interventions

Robotic Exoskeleton Gait Therapy BEHAVIORAL

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.

Cerebral Palsy Youth/Young Adults Robotic Exoskeleton

Physical Therapy BEHAVIORAL

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

Cerebral Palsy Youth/Young Adults Physical Therapy

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For Cerebral Palsy participants:
• Cerebral Palsy diagnosis
• For Non-Cerebral Palsy Controls:
• No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)

You may not qualify if:

• No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.

Sponsors & Collaborators

• Father Flanagan's Boys' Home: lead

Study Sites (1)

Boys Town National Research Hospital

Boys Town, Nebraska, 68010, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Max J Kurz, PhD

  Father Flanagan's Boys' Home

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of PoWER Lab

Model Details: Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive traditional gait therapy, and then repeat mobility/brain imaging testing. Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive gait therapy utilizing robotic exoskeleton, and then repeat mobility/brain imaging testing.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: December 2, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Upon completion of study and data analysis.
• Access Criteria: Contact Dr. Kurz

Locations

US (1)