Balance and Posture in Adults With Cerebral Palsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Temple University
Sponsor:
Information provided by (Responsible Party):
Richard Lauer, Temple University
ClinicalTrials.gov Identifier:
NCT01585571
First received: April 18, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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.


Condition
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Balance and Posture in Adults With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Center of Mass and Center of Pressure [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Muscle activity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Muscle activity (recording using surface electrodes) will be performed while subjects are looking at different visual scenes and with slow force plate movements.

  • Movement of the legs and trunk [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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.

  • Visual dependence [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
50 individuals of typical development with no known neuromuscular issues.
Adults with CP
Individuals with a pediatric diagnosis of spastic, diplegic or quadriplegic cerebral palsy.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585571

Contacts
Contact: Elizabeth D Thompson, DPT, NCS 267.702.4031 TempleUPTresearch@gmail.com
Contact: Cristine Agresta, PT 267.702.4031 TempleUPTresearch@gmail.com

Locations
United States, Pennsylvania
Temple University, VEPO Laboratory Recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: Richard T Lauer, PhD         
Principal Investigator: Emily A Keshner, PT, EdD         
Principal Investigator: Carole A Tucker, PT, PhD, NCS         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Richard T Lauer, PhD Temple University
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Lauer, Assistant Professor, Temple University
ClinicalTrials.gov Identifier: NCT01585571     History of Changes
Other Study ID Numbers: R01HD069769
Study First Received: April 18, 2012
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Temple University:
Balance
Posture
Virtual Environment
Cerebral Palsy
Adults

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014