Cerebral PalsyNCT01585571
Balance and Posture in Adults With Cerebral Palsy
An observational study of Cerebral Palsy, run by Temple University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 5 Feb 2020
- Phase
- Observational
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University, VEPO Laboratory
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Keywords
- Balance, Posture, Virtual Environment, Cerebral Palsy, Adults
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | 50 individuals of typical development with no known neuromuscular issues. | |
| Adults with CP | 50 Individuals with a pediatric diagnosis of spastic, hemiplegic, diplegic or quadriplegic cerebral palsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Mass and Center of Pressure
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.
Measured: 4 hours
Secondary outcomes (3)
Muscle activity
Muscle activity (recording using surface electrodes) will be performed while subjects are looking at different visual scenes and with slow force plate movements.
Measured: 4 hours
Movement of the legs and trunk
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.
Measured: 4 hours
Visual dependence
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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startApr 2012
- Primary completion5 Feb 2020
- Study completion5 Feb 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Lauer, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585571
- Sponsor's protocol ID
- R01HD069769
- Status last verified
- Feb 2020
- First submitted
- 18 Apr 2012
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Balance and Posture in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01585571
- Acronym / sponsor ID
- R01HD069769
- Conditions
- Cerebral Palsy
- Keywords
- Balance, Posture, Virtual Environment, Cerebral Palsy, Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 26 Apr 2012 (estimated)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –50 individuals of typical development with no known neuromuscular issues. |
| Adults with CP | – | –50 Individuals with a pediatric diagnosis of spastic, hemiplegic, diplegic or quadriplegic cerebral palsy. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Center of Mass and Center of Pressure
Time frame: 4 hours
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.
3 secondary outcomes
Muscle activity
Time frame: 4 hours
Movement of the legs and trunk
Time frame: 4 hours
Visual dependence
Time frame: 1 hour
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 7 Feb 2020.
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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.
Richard T Lauer, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Temple University 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 4 inclusion and 2 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 7 Feb 2020. 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?
Center of Mass and Center of Pressure (time frame: 4 hours). 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 7 Feb 2020.