Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123708
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-07-23
Brief Title:
Hypertonia in Patients With Cerebral Palsy
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Hypertonia in Patients With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2009-11-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will classify types of hypertonia in patients with cerebral palsy and determine if the classifications are reasonable in relation to the functional task of walking Hypertonia is an abnormal increase in muscle tension It is a common symptom of cerebral palsy that can lead to loss of function and deformity This study may help scientists improve evaluation criteria for hypertonia and ultimately treatment results
Patients with cerebral palsy who are older than 6 years of age may be eligible for this study Candidates are screened with a medical history and clinical evaluation
Participants are asked to walk in the lab while cameras record their movement During this test subjects wear a t-shirt and shorts with their arms and legs wrapped with a soft rubber-like material A piece of firm material is attached to the rubber sleeves and small plastic reflective balls are attached to the firm material Balls may also be attached to the skin using an adhesive With the balls in place the subject walks several times while cameras record the positions of the balls In addition small metal electrodes attached to the skin with an adhesive measure the electrical activity in the muscles
After the walking test is completed subjects leg muscle strength is measured with a special device while they perform three activities First they sit on a special chair with their leg and foot placed in an apparatus that measures their strength then lie on their back then on their stomach and then stand on one foot holding a bar to balance during part of one activity During the activities their reflexes are tested they are asked to move their legs and their legs are moved for them
Patients with cerebral palsy who are older than 6 years of age may be eligible for this study Candidates are screened with a medical history and clinical evaluation
Participants are asked to walk in the lab while cameras record their movement During this test subjects wear a t-shirt and shorts with their arms and legs wrapped with a soft rubber-like material A piece of firm material is attached to the rubber sleeves and small plastic reflective balls are attached to the firm material Balls may also be attached to the skin using an adhesive With the balls in place the subject walks several times while cameras record the positions of the balls In addition small metal electrodes attached to the skin with an adhesive measure the electrical activity in the muscles
After the walking test is completed subjects leg muscle strength is measured with a special device while they perform three activities First they sit on a special chair with their leg and foot placed in an apparatus that measures their strength then lie on their back then on their stomach and then stand on one foot holding a bar to balance during part of one activity During the activities their reflexes are tested they are asked to move their legs and their legs are moved for them
Detailed Description:
Cerebral palsy CP affects 025 of newborn babies in the US alone each year Hypertonia increased joint resistance to externally imposed motion is a common symptom that limits function in this patient population It may originate in spasticity dystonia or rigidity or may be a combination of all these factors Surgical rehabilitation and pharmacotherapeutic methods are used to improve functional outcome in patients with cerebral palsy These treatments are not always effective and the amount of improvement is difficult to predict The choice of treatment is based on clinical tests that are not objective especially in children and they do not allow for differentiation between various causes of increased joint resistance As a result ineffective treatments are offered to patients with different types of movement disorders The complex torque devices used in research facilities to quantify the resistance of a joint cannot be easily applied in clinical settings In previous studies a portable measurement method was developed based on a hand-held force transducer which allowed for the quantification of biomechanical and bioelectrical characteristics of resistance of a knee joint at different velocities Using this method we found different types of hypertonia that had not been previously reported in patients with cerebral palsy It is not clear to what degree hypertonia restricts an ability to execute selected functional tasks due in part to the considerable variability in patients with CP If this variability could be decreased the relationship between restricted ability and the different types of hypertonia would be easier to determine Strong arguments exist to consider different pathophysiologies in these different types of hypertonia
The aim of this non-invasive study is to sub-classify patients with CP based on the type of knee hypertonia and to determine if the classification is valid during the functional tasks of walking When validated it can serve as a predictive model for the relationship between the clinical evaluation at bedside and functional outcome
To classify hypertonia the resistance of a knee joint at different velocities in knee flexion and extension and the maximum activation of stretched and shortened muscles are measured with a hand-held force transducer an electrogoniometer and surface electrodes in 100 patients with CP The strength of velocity-dependent hypertonia during passive stretch and position andor velocity thresholds will be calculated The knee extension and flexion muscles will be classified bilaterally as normal or as one of the four types based on the pattern of activation of stretched muscles To determine the impact of other impairments on the function the maximum isometric knee flexion and extension strength and the monosynaptic reflexes of the rectus femoris muscle will be measured
At the functional level we will evaluate knee motion during walking To determine the impact of hypertonia on function the Spearman R correlation will be used to analyze data in patients within the same class To determine if the classification holds during walking the Cronbachs alpha coefficient will be calculated The significance of differences will be tested at the level of significance alpha less than or equal to 005
It is expected that as a result of this study better criteria for classifying patients into predictable categories correlated to specific therapeutic responses will be established In the future the improvement of differential diagnoses with quantitative methods will increase the effectiveness of treatment by customizing the needs of each patient
The aim of this non-invasive study is to sub-classify patients with CP based on the type of knee hypertonia and to determine if the classification is valid during the functional tasks of walking When validated it can serve as a predictive model for the relationship between the clinical evaluation at bedside and functional outcome
To classify hypertonia the resistance of a knee joint at different velocities in knee flexion and extension and the maximum activation of stretched and shortened muscles are measured with a hand-held force transducer an electrogoniometer and surface electrodes in 100 patients with CP The strength of velocity-dependent hypertonia during passive stretch and position andor velocity thresholds will be calculated The knee extension and flexion muscles will be classified bilaterally as normal or as one of the four types based on the pattern of activation of stretched muscles To determine the impact of other impairments on the function the maximum isometric knee flexion and extension strength and the monosynaptic reflexes of the rectus femoris muscle will be measured
At the functional level we will evaluate knee motion during walking To determine the impact of hypertonia on function the Spearman R correlation will be used to analyze data in patients within the same class To determine if the classification holds during walking the Cronbachs alpha coefficient will be calculated The significance of differences will be tested at the level of significance alpha less than or equal to 005
It is expected that as a result of this study better criteria for classifying patients into predictable categories correlated to specific therapeutic responses will be established In the future the improvement of differential diagnoses with quantitative methods will increase the effectiveness of treatment by customizing the needs of each patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-0204 | None | None | None |