Treatment Trials

13 Clinical Trials for Various Conditions

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WITHDRAWN
Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
Description

The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.

RECRUITING
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Description

The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.

COMPLETED
Brain Reorganization Following Constraint-Induced Therapy in Children With Cerebral Palsy
Description

This study will examine how therapy changes the way the brain controls movements in children with cerebral palsy. Normally, one side of the brain controls movements in the opposite side of the body. In cerebral palsy, however, this pattern may be different, with one side of the brain controlling movements on the same side of the body. This study will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) to study brain function in children with cerebral palsy before and after therapy. Children between 9 and 17 years of age with spastic hemiplegia type cerebral palsy will be recruited for this study from the National Rehabilitation Hospital and Georgetown University Center Medical Center in Washington, D.C., and the Sparks Center at UAB in Alabama. In addition, five healthy control children will be recruited from community groups, such as Cub Scouts, Brownies, and schools. Candidates are screened with a review of medical records and neurological and physical examinations. Healthy controls undergo MRI (described below) twice, 3 weeks apart. Children with cerebral palsy undergo the following tests and procedures: 1. Rehabilitation evaluation at the NIH Clinical Center Rehabilitation Medicine Department. 2. MRI: For this test, the child lies on a table that slides in and out of the MRI scanner-a metal cylinder surrounded by a strong magnetic field. He or she wears earplugs to muffle loud knocking sounds that occur during scanning. Images are obtained while the child performs simple finger tapping movements. 3. Movement Testing: 1. Finger tapping: The child taps buttons on a box hooked up to a computer 2. Muscle reflex measurements: One method uses a small motor that makes the child's fingers move with sudden, small movements; a second method uses small shocks to the finger or wrist. The shocks feel like a buzz; most are gentle, but some might feel stronger. 4. TMS: This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the child may be asked to perform simple movements.. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the child may hear a click and feel a pulling sensation on the skin under the coil. 5. Therapy: After these tests, children are randomly selected to receive either standard therapy (neurodevelopmental treatment) or constraint-induced therapy, as follows: 1. Neurodevelopmental therapy uses principles of movement science to enhance the child's capacity to function. The child receives therapy a few times a week for 3 weeks. 2. Constraint-induced therapy uses a combination of motor learning method and constraint to teach the new motor skills in the child's affected hand. Children treated with this therapy must live near a special treatment center in Alabama for the 3 weeks of treatment. The child's good arm is constrained with a bivalve, removable cast. The cast is placed before therapy starts and remains in place except when the therapist removes it once a day to examine the good arm. With the cast on, children are encouraged to use their affected hand in new ways. The therapist then uses the motor learning method, building motor programs as a result of practice, to teach them new skills. Motor learning therapy is 6 hours a day. 6. Post-treatment testing: After treatment, children undergo repeat rehabilitation assessment, MRI, TMS, and movement testing.

Conditions
COMPLETED
Brain Control of Movements in Cerebral Palsy
Description

This study will examine how the brain controls movements in patients with certain types of cerebral palsy. In healthy people, one side of the body usually controls movements on the other side of the body. In patients with cerebral palsy, this pattern may be altered, and one side of the brain may control movements on the same side of the body. Information obtained from this study may lead to improved rehabilitation therapy strategies for patients with cerebral palsy. Healthy volunteers and patients with cerebral palsy between 6 and 18 years of age may be eligible for this study. All candidates will be screened with a medical history, physical examination, and psychological testing. In addition, patients with cerebral palsy will have hearing and vision tests, a review of their medical records, and a magnetic resonance imaging (MRI) scan if one has not been done within the past year. For this test, the patient lies on a table that slides into a narrow metal cylinder with a strong magnetic field (the scanner). The scanning time usually lasts between 45 and 90 minutes. Patients enrolled in the study also will be evaluated by a physiatrist and physical and occupational therapists. They will be examined for muscle stiffness and reflexes. Their gait and movements (e.g., how they pick up a glass of water) will be evaluated. They will be asked about their ability to perform activities around the house and at school and whether a wheelchair or walker is needed to get around. Patients may also be asked about how they are dealing with their movement problems and how it affects their caregivers. All participants will undergo three tests, described below, to evaluate movement control. The first two tests use electrodes (small metal discs) taped to the skin over the muscles in both hands to measure muscle activity. A small disc placed on the fingers detects and measures the hand movements. The third test uses magnetic pulses that stimulate the brain to study how the brain controls movements. 1. Quantitative test of fine motor function: For this test, the subject taps buttons at different speeds on a box attached to a computer. The test is similar to playing simple computer games. 2. Long latency reflexes: For this test, the subject's hand is lightly strapped into a holder that holds the hand still while a motor moves the index finger with sudden small movements. These reflexes may also be tested using a gentle shock to the finger delivered through a ring electrode. 3. Transcranial magnetic stimulation: For this test, the subject sits in a comfortable chair. An insulated coil is held on the scalp. A magnetic pulse from the coil stimulates the brain. The subject may hear a click and feel a snap or pulling sensation on the scalp under the coil. The stimulation may also cause twitching in the muscles of the arm or leg. During the stimulation, the subject may be asked to move certain muscles or perform other simple actions.

Conditions
COMPLETED
Eye-Hand Coordination in Children With Spastic Diplegia
Description

This study will examine how the brain controls eye-hand coordination (visuomotor skills) in children with spastic diplegia and will determine whether impairment of this skill is related to the learning difficulties in school that some of these children experience. Spastic diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain injury causing the leg problem in this disease may also cause difficulty with eye-hand coordination. Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age may be eligible for this study. Candidates will be screened with a review of medical and school records, psychological testing, neurological and physical examinations, and assessment of muscle function in the arms and legs. Participants may undergo one or more of the following procedures: Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering questions, such as whether the letters on the screen make up a real word. Magnetic resonance imaging (MRI) (45 minutes) - uses a strong magnetic field and radio waves to provide images of the brain. The child lies on a table in a narrow cylindrical machine while the scans are obtained. Both the child and parent wear earplugs to muffle the loud noise the radio waves make while the images are formed. Electroencephalography (EEG) and electromyography (EMG) (1 to 2 hours) - EEG uses electrodes to record the electrical activity of the brain. The electrodes are in a special cap that is worn on the head during the procedure. EMG records electrical activity from muscles. Electrodes are placed on the skin over certain muscles. During the test, the child makes simple repetitive movements, such as finger tapping. The cap and the electrodes on the skin are removed at the end of the test.

COMPLETED
Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function
Description

The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

TERMINATED
Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke
Description

The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investigational device (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) are able to improve wrist stiffness and motor function, when combined with intensive robotic wrist training program in participants with chronic spastic hemiparesis after stroke.

ACTIVE_NOT_RECRUITING
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
Description

Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension safety trial.

ACTIVE_NOT_RECRUITING
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Description

Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension safety trial.

Conditions
COMPLETED
Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Description

A randomized control trial to test the efficacy of a new treatment involving intensive home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive home-based functional lower-limb training in children with hemiplegia. The protocols have been developed at TC Columbia University to be child friendly and draw upon the investigators experience since 1998 with intensive movement therapy in children with cerebral palsy. The aim is to promote either the use/coordination of movement of the hands or improve lower-limb balance, strength, and function. Caregivers will be trained at the investigator center and then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of activities with their child in their own home. The activities will be supervised by the investigators team via computer. Participants do NOT need to live in the New York City area, but a one-time weekend visit to the investigators center is required for training. All measurement and treatment is performed in the home. Participants are randomized to receive either HABIT or lower-limb training. If caregivers wish, they may chose to be crossed over at the end of the study and trained to receive the other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more information: http://www.tc.edu/centers/cit/

Conditions
COMPLETED
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
Description

The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period. The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.

COMPLETED
Passive Tactile Stimulation for Stroke Rehabilitation
Description

Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.

RECRUITING
Robot Aided Rehabilitation - Multi-joint Evaluations
Description

Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.

Conditions