Cerebral PalsyNCT03555708
Mobility Exercises for Gait (MEG Neuroplasticity Project)
A study testing Physical Therapy in people with Cerebral Palsy, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center Munroe Meyer Institute
Omaha, Nebraska, 68198
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.
Read the 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
- Being tested
- Physical Therapy
- Keywords
- Gait Training, Power Training, Action-Perception Training, Brain Imaging, Mobility
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Also called Therapeutic Gait Training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Secondary outcomes (7)
Change in Resting Cortical Activity - MEG
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.
Measured: Baseline and 8 weeks
Change in Mobility - Dynamic Gait Index
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.
Measured: Baseline and 8 weeks
Change in Muscle Performance - Biodex
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.
Measured: Baseline and 8 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Measured: Baseline and 3 Months Post and 6 Months Post Treatment
Change in Participation in Environment Measure for Children and Youth (PEM-CY)
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.
Measured: Baseline and 3 Months Post and 6 Months Post Treatment
Change in Activity - Actograph
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
Measured: Baseline 2 week days and two weekends, Post Treatment 2 week days and two weekends
Change in Hoffmann Reflex (H-reflex)
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start31 May 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max J Kurz, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555708
- Sponsor's protocol ID
- 0082-18-FB
- Other IDs
- Department Funding
- Status last verified
- Aug 2024
- First submitted
- 11 May 2018
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI and all of the investigators have made a commitment to publish, in a timely manner, all of the relevant scientific information that they will derive during this project. Publications will be in accordance with NIH guidelines. Unpublished information will be made available to interested parties via a request to the Principal Investigator (Dr. Kurz). Following publication, raw neuroimaging (MEG, MRI), biomechanical data, and clinical assessments will be made publicly available to the research community through a hyperlink on the PI's personal website at the University of Nebraska Medical Center (UNMC). These data will be de-identified, in accordance with the rules of the Institutional Review Board (IRB) of the UNMC. Such data sharing will allow replication of this study's primary findings, as well as opportunities for new findings as other investigators may apply different analysis methods, including new methods that may emerge in the future.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility Exercises for Gait (MEG Neuroplasticity Project)
- ClinicalTrials.gov ID
- NCT03555708
- Acronym / sponsor ID
- 0082-18-FB
- Conditions
- Cerebral Palsy
- Keywords
- Gait Training, Power Training, Action-Perception Training, Brain Imaging, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Velocity Power Training | Experimental | Other: Physical TherapyTraining 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. |
| Perception-Action Physical Therapy | Experimental | Other: Physical TherapyThe 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. |
| Body Weight Supported Treadmill Training | Experimental | Other: Physical TherapyThe 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. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyAlso: Therapeutic Gait TrainingPhysical 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 | Body Weight Supported Treadmill Training, High-Velocity Power Training, Perception-Action Physical Therapy |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Change in Resting Cortical Activity - MEG
Time frame: Baseline and 8 weeks
Change in Mobility - Dynamic Gait Index
Time frame: Baseline and 8 weeks
Change in Muscle Performance - Biodex
Time frame: Baseline and 8 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline and 3 Months Post and 6 Months Post Treatment
Change in Participation in Environment Measure for Children and Youth (PEM-CY)
Time frame: Baseline and 3 Months Post and 6 Months Post Treatment
Change in Activity - Actograph
Time frame: Baseline 2 week days and two weekends, Post Treatment 2 week days and two weekends
Change in Hoffmann Reflex (H-reflex)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Yes. The PI and all of the investigators have made a commitment to publish, in a timely manner, all of the relevant scientific information that they will derive during this project. Publications will be in accordance with NIH guidelines. Unpublished information will be made available to interested parties via a request to the Principal Investigator (Dr. Kurz). Following publication, raw neuroimaging (MEG, MRI), biomechanical data, and clinical assessments will be made publicly available to the research community through a hyperlink on the PI's personal website at the University of Nebraska Medical Center (UNMC). These data will be de-identified, in accordance with the rules of the Institutional Review Board (IRB) of the UNMC. Such data sharing will allow replication of this study's primary findings, as well as opportunities for new findings as other investigators may apply different analysis methods, including new methods that may emerge in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max J Kurz, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Cerebral Palsy, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Activity in Motor Cortices - MEG (time frame: Baseline and 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.