Mobility Exercises for Gait (MEG Neuroplasticity Project)

NCT ID: NCT03555708

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2020-12-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High-Velocity Power Training

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: 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.

Perception-Action Physical Therapy

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: 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.

Body Weight Supported Treadmill Training

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: 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.

Interventions

Physical Therapy

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.

Intervention Type: OTHER

Other Intervention Names

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Max J Kurz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center Munroe Meyer Institute

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

Department Funding

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0082-18-FB

Identifier Type: -

Identifier Source: org_study_id