Clinical trial NCT03555708: Mobility Exercises for Gait (MEG Neuroplasticity Project)
Official title: Mobility Exercises for Gait (MEG Neuroplasticity Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Gait Training
Power Training
Action-Perception Training
Brain Imaging
Mobility
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 39
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is directed at identifying a the neurophysiological changes seen in children with cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will: (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2) determine the mobility, participation and muscular performance improvements after therapy, and (3) determine the changes in a child's participation in activities outside of the laboratory environment.

Detailed description: This study is directed at identifying a the neurophysiological changes seen in children with cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will: (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2) determine the mobility, participation and muscular performance improvements after therapy, and (3) determine the changes in a child's participation in activities outside of the laboratory environment. The study consists of a cohort of children with CP that will undergo an action-perception training protocol, a cohort that will undergo a high velocity power training protocol and a cohort that will undergo body weight supported treadmill training. Participants will be between the ages of 9-18 years and have gross motor function classification score levels between I-III. All participants will complete final initial baseline measures of their brain activity, mobility, muscle performance, and participation activity outside of the laboratory. After completing these tests, the children will undergo the respective physical therapy protocols for 8-weeks (3 days a week). After the 8-weeks of therapy, both groups will repeat the same tests that were completed at baseline. Follow-up assessment will consist of a physical therapist scheduling a time to visit the family at their house and ask them questions about the child's participation in activities.

Eligibility criteria: Inclusion Criteria:

* Sustained a brain injury around the time of birth or a diagnosis of Cerebral Palsy
* Must be able walk without a wheelchair (GMFCS I-III)

Exclusion Criteria:

* Children dependent on a wheel chair for mobility
* Braces, permanent retainers, or metal in the head (creates artifact in the MEG)
* Orthopedic surgery within last 6 months
* Botulinum injections within the last 6 months

Primary outcomes:
measure: Change in Brain Activity in Motor Cortices - MEG
timeFrame: Baseline and 8 weeks
measure: Change in Brain Activity in Sensory Cortices - MEG
timeFrame: Baseline and 8 weeks
measure: Change in Mobility - 10-Meter Walk
timeFrame: Baseline and 8 weeks
measure: Change in Mobility - 1-Minute Walk
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Resting Cortical Activity - MEG
timeFrame: Baseline and 8 weeks
measure: Change in Mobility - Dynamic Gait Index
timeFrame: Baseline and 8 weeks
measure: Change in Muscle Performance - Biodex
timeFrame: Baseline and 8 weeks
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline and 3 Months Post and 6 Months Post Treatment
measure: Change in Participation in Environment Measure for Children and Youth (PEM-CY)
timeFrame: Baseline and 3 Months Post and 6 Months Post Treatment
measure: Change in Activity - Actograph
timeFrame: Baseline 2 week days and two weekends, Post Treatment 2 week days and two weekends
measure: Change in Hoffmann Reflex (H-reflex)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center Munroe Meyer Institute
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Max J Kurz, PhD
role: PRINCIPAL_INVESTIGATOR
References: