AzTrials
AzTrials

Cerebral PalsyNCT00123708

Hypertonia in Patients With Cerebral Palsy

An observational study of Cerebral Palsy and Muscle Hypertonia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy, Muscle Hypertonia
How many people
100 participants
Where
1 siteUnited States
Study dates
19 Jul 2005to 13 Nov 2009
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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • This study will include children and adult patients with cerebral palsy, patients with dystonia, and able-bodied children older than 6 years of age. Each patient must meet the following criteria:
  • The patient must have a diagnosis of cerebral palsy or dystonia
  • The patient must be able to follow the instructions to successfully complete the testing
  • The patient must be properly motivated and willing to do the tasks.
  • The patient must be older than 6 years
  • The patient must score a 2 or 3 on the walking subsection of the Gross Motor Function Classification System (GMFCS).
  • The patient must cease taking medications known to affect spasticity at least 48 hours before the first investigation; however, if any antispasticity medication is longstanding and stable it should be maintained during the entire study.

Who cannot join

  • Inability of the patient to follow the instructions to accomplish the task.
  • Structural deformities at the level of a knee joint.
  • If patients are unable to complete all the tasks or conditions they can still be enrolled to complete part of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

Cerebral palsy (CP) affects 0.25% of newborn babies in the U.S. 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, and/or 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 Cronbach's alpha coefficient will be calculated. The significance of differences will be tested at the level of significance alpha less than or equal to 0.05.

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.

Keywords
Spasticity, Dystonia, Movement Disorders, Walking, Muscle Weakness, Resistance, Gait, Cerebral Palsy, CP
Medical subject headings
Cerebral Palsy, Muscle Hypertonia, Muscle Spasticity, Dystonia, Movement Disorders, Muscle Weakness

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2005 (estimated)
  2. Study start19 Jul 2005
  3. Primary completion13 Nov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123708
Sponsor's protocol ID
050204
Other IDs
05-CH-0204
Status last verified
13 Nov 2009
First submitted
23 Jul 2005
Last updated
2 Jul 2017
Results posted
No

Publications

  • ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.

    PubMed 14143329
  • Barry MJ, VanSwearingen JM, Albright AL. Reliability and responsiveness of the Barry-Albright Dystonia Scale. Dev Med Child Neurol. 1999 Jun;41(6):404-11. doi: 10.1017/s0012162299000870.

    PubMed 10400175
  • Blackburn M, van Vliet P, Mockett SP. Reliability of measurements obtained with the modified Ashworth scale in the lower extremities of people with stroke. Phys Ther. 2002 Jan;82(1):25-34. doi: 10.1093/ptj/82.1.25.

    PubMed 11784275

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy and Muscle Hypertonia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 7 inclusion and 3 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 2 Jul 2017. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00123708, which also lists 3 linked publications.

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 2 Jul 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in