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Completed

NCT Number: NCT03555708

Mobility Exercises for Gait (MEG Neuroplasticity Project)

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.

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center Munroe Meyer Institute

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

Physical therapy will be implemented three times a week with subjects over an eight week span. Each physical therapy session will last 40-minutes and will be conducted by a licensed physical therapist.

Other names: Therapeutic Gait Training

Primary outcomes

  1. Change in Brain Activity in Motor Cortices - MEG

    Time frame: Baseline and 8 weeks

    To assess the activity of the motor cortices, the child will produce an isometric knee extension force to match a target that is between 5-30% of his/her maximum voluntary force. The children will be instructed to perform the target matching task as rapidly and as accurately as possible. The MEG experiment will involve the child performing ~120 isometric target matching trials.

  2. Change in Brain Activity in Sensory Cortices - MEG

    Time frame: Baseline and 8 weeks

    To assess the activity of the somatosensory cortices, a tactile stimulation will be applied to the bottom of the foot at the first metatarsal using a small airbladder. For each child, 120 paired-pulse trials will be collected using an inter-stimulus interval of 500 ms, and an inter-pair interval that randomly varied between 4.5 and 4.8 s.

  3. Change in Mobility - 10-Meter Walk

    Time frame: Baseline and 8 weeks

    The childs 10-meter preferred and fast-as-possible walking speeds will be evaluated. The children will complete three trials at each speed, and the mean of the respective trials will be the key metric. During these tests, the child will walk across a GaitRITE digital mat (CIR Systems, Sparta, NJ) that will quantify the walking speed, step length, step width and cadence.

  4. Change in Mobility - 1-Minute Walk

    Time frame: Baseline and 8 weeks

    The child's walking endurance will be assessed by asking them to walk as far as possible for a one-minute time period. Cones will be placed at the ends of a 40-m hallway and the child will be asked to walk back and forth during the time period. During the walk the child will wear a heart-rate monitor and wireless accelerometers that are positioned on the lower back and feet. The heart-rate monitor will be used as an indirect measure of the child's physical fitness, while the accelerometers will be used assess the child's dynamic balance.

Secondary outcomes

  1. Change in Resting Cortical Activity - MEG

    Time frame: Baseline and 8 weeks

    The resting state activity of the brain will also be collected. This will involve the child sitting quietly with his/her eyes closed for 5 minutes.

  2. Change in Mobility - Dynamic Gait Index

    Time frame: Baseline and 8 weeks

    The child will be asked to perform a series of mobility tasks such as stepping over shoe-box, changing their gait speed, walking up stairs, turning head while walking, etc. These series of standardized test will be used to assess the child's gait adaptability.

  3. Change in Muscle Performance - Biodex

    Time frame: Baseline and 8 weeks

    A Biodex System 3 dynamometer will be used to assess the isometric strength and power production of the right and left knee joint musculature separately. Standard alignment of the knee joint axis with the dynamometer and set-up will be implemented. Separate knee extensor and flexor isometric strength tests will initially be measured from three maximal trials with the knee flexed at 90 degrees. This will be followed by the child performing maximal knee extensor/flexion concentric contractions with the dynamometer set at 30 deg/sec, 60 deg/sec and 120 deg/sec. The peak torque generated from the five contractions performed in each of the respective sets will be used as an outcome variable.

  4. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline and 3 Months Post and 6 Months Post Treatment

    Survey that evaluates the child's self-reported physical activity, strength and pain. The PROMIS will be completed at baseline and at the 3 and 6 months after therapy. A physical therapist will perform the 3 and 6 month follow-up assessments at the family's home.

  5. Change in Participation in Environment Measure for Children and Youth (PEM-CY)

    Time frame: Baseline and 3 Months Post and 6 Months Post Treatment

    A survey to be completed by the child's parent/primary caregiver to gather information about the child's current level of participation in home, school and community environments. The survey will provide information regarding frequency of various activities performed, level of involvement during these activities and the parent/caregivers level of desire to see change in the child's involvement in activities. The PEM-CY will be completed at baseline and at the 3 and 6 months after therapy. A physical therapist will perform the 3 and 6 month follow-up assessments at the family's home.

  6. Change in Activity - Actograph

    Time frame: Baseline 2 week days and two weekends, Post Treatment 2 week days and two weekends

    The child will wear an activity tracker at their waist while they are at home, in the community and at school. The activity tracker will be worn for 2 weekdays and 2 weekend days. The average across this time period will be used to assess the activity levels of the child outside of the laboratory setting. These measurements will be performed at baseline and after completing the therapy protocol

  7. Change in Hoffmann Reflex (H-reflex)

    Time frame: Baseline and 8 weeks

    This tests is similar to how a medical doctor performs a tendon tap to assess a child's reflexes. The only difference is the methods that will be employed in this study can quantify the magnitude of the reflex. The H-reflex will be elicited by simulating the tibial or median nerve with a constant current electrical simulator. the muscular activity generated by the stimulus will be measured with EMG. The peak amplitude of the H-reflex seen in the EMG signal will be determined by gradually increasing the stimulus until the amplitude of the reflex no longer increases. Changes in the amplitude before the therapy and after will be used as an indirect assessment of spinal cord plasticity.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2018
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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