Mobility Exercises for Gait (MEG Neuroplasticity Project)

NCT03555708 | Completed

• 2 other identifiers: 0082-18-FBDepartment Funding
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Gait Training; Power Training; Action-Perception Training; Brain Imaging; Mobility

Outcome Measures

Primary Outcomes (4)

• Change in Brain Activity in Motor Cortices - MEG

  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.

  Baseline and 8 weeks

• Change in Brain Activity in Sensory Cortices - MEG

  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.

  Baseline and 8 weeks

• Change in Mobility - 10-Meter Walk

  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.

  Baseline and 8 weeks

• Change in Mobility - 1-Minute Walk

  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.

  Baseline and 8 weeks

Secondary Outcomes (7)

• 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

Study Arms (3)

High-Velocity Power Training

EXPERIMENTAL

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.

Other: Physical Therapy

Perception-Action Physical Therapy

EXPERIMENTAL

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.

Other: Physical Therapy

Body Weight Supported Treadmill Training

EXPERIMENTAL

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.

Other: Physical Therapy

Interventions

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.

Also known as: Therapeutic Gait Training

Body Weight Supported Treadmill Training; High-Velocity Power Training; Perception-Action Physical Therapy

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center Munroe Meyer Institute

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Max J Kurz, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 13, 2018
• Study Start: May 31, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Upon completion of study and data analysis.
• Access Criteria: Contact Dr. Kurz

Locations

US (1)