Clinical trial NCT05158218: Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy
Official title: Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Gait Therapy
Mobility
Robotic Exoskeleton
Lead sponsor: Father Flanagan's Boys' Home
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 64
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Cerebral palsy (CP) results from a perinatal brain injury and is one of the most prevalent and costly pediatric neurologic conditions in the United States that often results in mobility deficits. The investigator's extensive experimental work has been focused on developing a therapeutic gait training protocol that will improve the long-term mobility of adolescents and young adults with CP. Robotic exoskeletons have gained recent attention in the therapeutic community as a high-tech option for assisting with over-ground mobility of various patient populations. The goal of this investigation is to take a fresh new approach on how robotic exoskeletons can be used in a therapeutic setting. As opposed to using them as a compensation tool, we are proposing to use them to perturb the legs to drive beneficial neuroplasticity in the key brain areas that govern the leg motor actions. Essentially, we predict that the neuroplastic changes promoted by the exoskeleton gait training protocol will lead to more robust clinical outcomes than what is seen by gait training alone. The aims of this study will: (1) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone, (2) determine if individuals that undergo a robotic exoskeleton gait training protocol have larger improvements in key brain areas involved in motor planning and execution of the leg motor actions compared to those that undergo gait training alone, and (3) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone. It is hypothesized after exoskeleton gait training participants will demonstrate substantially greater improvements in their 10-meter walk speed, one-minute walk test, and Functional Gait Assessment scores. Additionally, following exoskeleton training, the sensorimotor cortical activity will be significantly different from what is seen in those receiving gait training alone. Furthermore, the degree of brain activity changes will be related to the extent of the mobility improvements seen after completing the exoskeleton gait training protocol. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, and clinical mobility assessments. After completing the baseline tests, the participants will undergo either traditional therapeutic gait training or utilize the robotic exoskeleton gait therapy. Upon completion of the treatment program, participants will undergo the same baseline assessments. The results from the post therapy outcomes will be compared between the two groups: traditional gait therapy and robotic exoskeleton.

Eligibility criteria: Inclusion Criteria:

* For Cerebral Palsy participants:

  * Cerebral Palsy diagnosis
* For Non-Cerebral Palsy Controls:

  * No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Mobility Test Time
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Time for Community Ambulation
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Time for "Timed Up and Go"
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Selective Control Assessment of the Lower Extremity
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Level of Spasticity
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Isolation of Movement
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Brain Activity in Sensory Cortices
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Motor Response
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Change in Hoffmann Reflex
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Secondary outcomes:
measure: Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - D2 - Test of Attention
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Trail Making A+B
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
measure: Cognitive related changes induced via physical therapy - MacArthur Scale of Subjective Social Status Youth + Adult
timeFrame: Baseline (CP and Neurotypical) and 8 weeks (CP)
Other outcomes:
Locations:
city: Boys Town
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
Study officials:
affiliation: Father Flanagan's Boys' Home
name: Max J Kurz, PhD
role: PRINCIPAL_INVESTIGATOR
References: