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Cerebral Palsy clinical trials

View clinical trials related to Cerebral Palsy.

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NCT ID: NCT00238641 Completed - Cerebral Palsy Clinical Trials

“DOES MYOBLOC™ IMPROVE FUNCTIONAL HAND USE IN YOUNG CHILDREN WITH A HYPERTONIC UPPER EXTREMITY?”

Start date: January 2002
Phase: Phase 1/Phase 2
Study type: Interventional

In children with cerebral palsy, stiffness of the arm can develop early and delay or prevent the acquisition of normal hand skills. Improvement in functional use of the hand may therefore be dependent upon early treatment of upper extremity hypertonia. We propose to test a series of injections of Myobloc™ in a non-randomized one-way crossover pilot clinical trial and dose-finding study, with clinical assessments and blinded video evaluations. Ten children age 2-17 years with increased tone at the elbow or wrist will be expected to complete the study. A 1-month baseline evaluation period will be followed by an injection of low-dose Myobloc™ to affected muscle(s) of the arm according to standardized per-kilogram dosing with a maximum of 25U/kg in each affected arm. Three months later, a second injection of up to 50U/kg will be performed in each affected arm. Three months after the second dose, a third dose of up to 100U/kg will be performed in each affected arm. Neurological assessments will be performed at study entry, prior to each injection, and at 1 and 3 months following each injection. Routine physical therapy and non-study medications will be continued during the study.

NCT ID: NCT00221611 Completed - Cerebral Palsy Clinical Trials

Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity

Start date: January 2000
Phase: Phase 2
Study type: Interventional

Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

NCT ID: NCT00221247 Completed - Cerebral Palsy Clinical Trials

Acupuncture as Complementary Therapy for Cerebral Palsy

Start date: October 2004
Phase: Phase 2
Study type: Interventional

Background: Cerebral palsy (CP) is the most frequent cause of childhood disability in the US. Nevertheless, current standard of care for CP in the U.S. is to a large extent ineffective. The Chinese, on the other hand, claim to have an exceptionally high response rate with the administration of an integrated package of care that includes the combination of intense 'conventional' therapies and acupuncture. Despite numerous anecdotal reports, this claim has not yet been tested in a rigorous scientific way. Objective: To determine the effectiveness of acupuncture when used as an adjunct to intense 'conventional' physical, occupational, and hydro- therapies to improve function and quality of life in children with spastic CP. Hypotheses: (1) Adjunctive acupuncture therapy will improve the gross and fine motor function and the health related quality of life of children with spastic CP more than intense 'conventional' therapies alone. (2) The level of persistence of gross and fine motor function and health related quality of life achieved with adjunctive acupuncture administered in combination with intense 'conventional' therapies will be higher than those achieved with intense 'conventional' therapies alone. Design: A parallel, two-arm, prospective, evaluation-blind, pragmatic, non-inferiority, randomized controlled clinical trial (RCT). Setting: This international collaborative study will be conducted at two different localities: (1) At the Beijing Children's Hospital (BCH), where participants' recruitment, intervention therapies, videotape evaluation, and data collection will be done, and (2) At the University of Arizona, where scoring of the videotape evaluations and data analyses will be done, and from where logistic support will be provided to assure the scientific integrity of the study. Population: Approximately 100 children between the ages 1 and 6 years with spastic CP. Intervention: Concurrent administration of acupuncture with intense 'conventional' therapies at the outset of the study vs. sequential administration of both components. Outcomes: 'Gross Motor Function', 'Fine Motor Function', 'Range of Motion', 'Level of Motor Involvement', and 'Health-Related Quality of Life' measured at times 0,4,8,12,24,and 36 weeks. Evaluation: Independent blinded evaluation with respect to the type of the intervention and the stage of the therapeutic schedule done in the U.S. based on videotapes filmed in China. Data management: Web-based data center and intersite-networking infrastructure. Data analyses: Intention to treat analysis supplemented by linear mixed effects models with nested grouping factors. Significance and future directions: If the hypotheses are confirmed the study would lay the groundwork for future research, and impact clinical practice and health care policy as related to CP therapy.

NCT ID: NCT00210431 Completed - Cerebral Palsy Clinical Trials

Post Marketing Surveillance Study of Dysport

Start date: October 2004
Phase:
Study type: Observational

The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

NCT ID: NCT00202761 Completed - Cerebral Palsy Clinical Trials

Project:Intensive Habilitation (PIH)

Start date: March 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals. The study hypothesis are: Intensive training will speed up the childs motor, cognitive and social development. Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation

NCT ID: NCT00178217 Completed - Cerebral Palsy Clinical Trials

Music Therapy During Botulinum Injections

Start date: July 2002
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives for this study are: 1. To demonstrate that music therapy can be an effective means of procedural support for children undergoing botox injections. 2. To explore patient, parent and healthcare personnel satisfaction with music therapy as procedural support. 3. To assess the influence of music therapy on physiologic (blood pressure, oxygen saturation, heart rate) and emotional (crying time) responses of patients.

NCT ID: NCT00154830 Completed - Cerebral Palsy Clinical Trials

Alterations of Functional Activities and Leg Stiffness After Hamstring Lengthening in Cerebral Palsy Children

Start date: August 2004
Phase: Phase 4
Study type: Interventional

Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.

NCT ID: NCT00133861 Completed - Cerebral Palsy Clinical Trials

Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles

Start date: April 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.

NCT ID: NCT00123708 Completed - Cerebral Palsy Clinical Trials

Hypertonia in Patients With Cerebral Palsy

Start date: July 19, 2005
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00114075 Completed - Cerebral Palsy Clinical Trials

Effects of Walking Analysis on Surgical Outcomes

Start date: January 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.