- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585571
Balance and Posture in Adults With Cerebral Palsy
February 5, 2020 updated by: Temple University
Observational Study of Balance and Posture in Adults With Cerebral Palsy
The results of this study will have an impact upon public heath policy as adults with cerebral palsy (CP) present a growing and underserved population in the United States.
At the conclusion of this study, we will have identified the means by which the adult with CP maintains their upright position, which is essential for activities of daily living and for movement.
With this knowledge, it will be possible to develop clinical and rehabilitation interventions that will improve their arm and leg function, and reduce the risk of falls for the adult with CP.
Study Overview
Status
Completed
Conditions
Detailed Description
Individuals with Cerebral Palsy (CP) present with considerable functional heterogeneity, and demonstrate a marked decrease in functional status with age due to the development of disturbances in somatosensory function, secondary neuromuscular impairments, and poor control over the trunk muscles.
These factors promote balance instability, result in an increased fall risk, and contribute to lost functional capabilities.
Little is known about the progression of neuromotor and somatosensory impairments as individuals with CP age, thus a knowledge gap exists concerning postural control and balance in the adult with CP, particularly which those associated with aging (primary) and those associated with compensatory behaviors.
The objective of this proposal is to explore mechanisms behind abnormal motor response in postural control in the adult with CP.
We HYPOTHESIZE that somatosensory reliance, as well as muscle passive and active properties, change with aging and functional adaptation.
In order to address our central hypothesis, we propose the following specific aims: SPECIFIC Aim 1: To examine the central disturbances of sensory processing and sensorimotor integration that contribute to abnormal postural control in young adults with CP.
We will: a) determine the effect of visual dependence on postural control in the adult with CP as directly measured with a test for visual dependence; and b)relate the presence of visual dependence to the effect of disturbances of the visual flow field on the center of mass (CoM) and center of pressure (CoP) responses in the adult with CP; and c) determine the relationship between central disturbances of sensory processing and sensorimotor integration on functional balance as measured by standardized clinical assessments of balance and fall risk.
SPECIFIC Aim 2: To examine the peripheral alterations in passive muscle-tendon properties that could contribute to abnormal postural control in young adults with CP.
We will determine the effects of a disturbance of the base of support, a disturbance to the visual flow field, and a combined disturbance of the two on joint kinematics,CoP, and CoM responses in the adult with CP using functional principal component (time-series) analyses.
SPECIFIC Aim 3: To examine the impaired muscle activation and loss of selectivity over muscle control that contributes to abnormal postural control in young adults with CP.
We will determine the effects of a disturbance of the base of support, a disturbance to the visual flow field, and a combined disturbance of the two on the surface electromyographic (sEMG) activity of lower limb and trunk muscles using wavelet analyses.
At the conclusion of this study, we will have characterized postural control strategies employed by adults with CP in the presence of somatosensory and biomechanical perturbations.
The combination of our innovative methodology to challenge all aspects of the sensorimotor system, with our analytical approach of both time series and wavelet analysis of the data, will allow us to separate the primary dynamic postural deficits from compensatory actions, a critical distinction for optimizing treatment interventions.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University, VEPO Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The proposed investigation will be a cross-sectional study conducted with adolescents and young adults with typical development, and adolescents and young adults classified as having spastic diplegic or spastic quadriplegic CP between 15 and 30 years of age.
Description
Inclusion Criteria:
- Individuals with spastic diplegic or quadriplegic CP with the ability to stand for a period of 2 minutes
- Cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
- The control group will consist of age matched adults with no known neurological or somatosensory impairments.
- Subjects in all groups cannot have a reported sensitivity to motion sickness or visual field deficits or visual problems (lower than 20/40) not corrected by glasses.
Exclusion Criteria:
- Abnormal score for vestibular integrity as tested with the Dynamic Illegible 'E'-test
- Abnormal sensation to light touch and kinesthesia in the foot and ankle as assessed using the monofilament test.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Control
50 individuals of typical development with no known neuromuscular issues.
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Adults with CP
50 Individuals with a pediatric diagnosis of spastic, hemiplegic, diplegic or quadriplegic cerebral palsy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Center of Mass and Center of Pressure
Time Frame: 4 hours
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The investigators will measure the movement of the subject's center of mass and center of pressure using a force platform while they are looking at different visual scenes and with slow force plate movements.
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4 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle activity
Time Frame: 4 hours
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Muscle activity (recording using surface electrodes) will be performed while subjects are looking at different visual scenes and with slow force plate movements.
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4 hours
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Movement of the legs and trunk
Time Frame: 4 hours
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Movement of the knee, ankle, hip and trunk (recorded using surface mounted markers) will be performed while subjects are looking at different visual scenes and with slow force plate movements.
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4 hours
|
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Visual dependence
Time Frame: 1 hour
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Subjects will be seated in a chair, and asked to align a rotating rod to a vertical or horizontal position while receiving conflicting visual information ( a box placed around the rod in an off-center position)
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1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard T Lauer, PhD, Temple University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2012
Primary Completion (Actual)
February 5, 2020
Study Completion (Actual)
February 5, 2020
Study Registration Dates
First Submitted
April 18, 2012
First Submitted That Met QC Criteria
April 23, 2012
First Posted (Estimate)
April 26, 2012
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD069769 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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