Mobility Exercises for Gait (MEG Neuroplasticity Project)

Mobility Exercises for Gait (MEG Neuroplasticity Project)

Sponsors

Lead Sponsor: University of Nebraska

Source University of Nebraska
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.

Overall Status Recruiting
Start Date May 31, 2018
Completion Date May 28, 2023
Primary Completion Date May 28, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Brain Activity in Motor Cortices - MEG Baseline and 8 weeks
Change in Brain Activity in Sensory Cortices - MEG Baseline and 8 weeks
Change in Mobility - 10-Meter Walk Baseline and 8 weeks
Change in Mobility - 1-Minute Walk Baseline and 8 weeks
Secondary Outcome
Measure Time Frame
Change in Resting Cortical Activity - MEG Baseline and 8 weeks
Change in Mobility - Dynamic Gait Index Baseline and 8 weeks
Change in Muscle Performance - Biodex Baseline and 8 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Baseline and 3 Months Post and 6 Months Post Treatment
Change in Participation in Environment Measure for Children and Youth (PEM-CY) Baseline and 3 Months Post and 6 Months Post Treatment
Change in Activity - Actograph Baseline 2 week days and two weekends, Post Treatment 2 week days and two weekends
Change in Hoffmann Reflex (H-reflex) Baseline and 8 weeks
Enrollment 54
Condition
Intervention

Intervention Type: Other

Intervention Name: Physical Therapy

Description: 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 Name: Therapeutic Gait Training

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

Gender: All

Minimum Age: 9 Years

Maximum Age: 18 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Max J Kurz, PhD Principal Investigator Director of the Sensorimotor Learning Laboratory
Overall Contact

Last Name: Max J Kurz, PhD

Phone: 402.559.6415

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: University of Nebraska Medical Center - Munroe Meyer Institute - Sensorimotor Learning Laboratory Max J Kurz, PhD 402-559-6415 [email protected] Max J Kurz, PhD Principal Investigator Rashelle M Hoffman, DPT Sub-Investigator
Location Countries

United States

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Nebraska

Investigator Full Name: Max J. Kurz, PhD

Investigator Title: Director of the Sensorimotor Learning Laboratory

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: High-Velocity Power Training

Type: Experimental

Description: Training will consist of unilateral and bilateral leg presses (Total Gym GTS, San Diego CA), which will primarily target the quadriceps followed by the hip extensors and plantarflexors. Target load will be 40% to 80% of 1-repetition maximum (1RM) with progression toward 80%. Each participant will perform 3 to 5 sub-maximal efforts followed by 6 sets of 5 maximum-effort repetitions at the predetermined percentage of 1RM for each leg separately. Following the unilateral leg presses, 6 sets of 5 repetitions of bilateral leg presses will be performed at the predetermined percentage of 1RM. To minimize fatigue, 1-2 minutes of rest will be given between sets.

Label: Perception-Action Physical Therapy

Type: Experimental

Description: The therapy includes: activities of adequate intensity that promote gait adaptation and gait speed sustainment, exploratory activities that enhance the somatosensory experience through rich/novel movement, and optimally challenging activities that emphasize planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints. This includes a 15-minutes of sustaining and adapting gait speed while walking along a 40-meter hallway. Participants will alter their gait through exploratory movements. During the following 20 minutes participants will perform discrete problem solving activities including: waling backward sand stair negotiation.

Label: Body Weight Supported Treadmill Training

Type: Experimental

Description: The child will walk on the treadmill for 35-minutes, while the body weight is supported with an overhead system at 30 percent of the child's body weight, reducing every other week by 10 percent until no support is provided during the final 2 weeks. Treadmill speed will be set at 90% of the child's over ground walking speed, gradually increasing each session. Speed adjustments depend on the child's ability to control their steps and achieve: activities that promote symmetry of the leg kinematics, activities that promote maintaining an upright lower limb posture and clearing the tow during the swing, and activities that promote pushing off with ankle at terminal stance.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov