Treatment Trials

16 Clinical Trials for Various Conditions

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RECRUITING
Grand Valley State University (GVSU) Skills on Wheels
Description

Manual wheelchairs (MWCs) are widely used by children with physical disabilities, yet many of these children are unable to use their wheelchair independently. Instead, they depend on others to push them. This dependency results in limited opportunities to decide what they want to do and where they want to go, leading to learned helplessness, social isolation, decreased participation, and restricted involvement in physical activities. Furthermore, unsafe MWC use increases the risk of injury, as highlighted by the 44,300 children treated each year in emergency departments for MWC-related injuries. While independent MWC mobility can positively influence quality of life, MWC skills training must also be provided to promote safe, independent MWC use. The effectiveness of MWC training programs for adults is well established, yet the current standard-of-care does not include MWC skills training for children and research regarding the efficacy of pediatric MWC skills training programs is limited. Skills on Wheels seeks to address these gaps and provide pilot data for a future large-scale, multi-site research project involving a randomized controlled trial. Aim 1 is to explore the influence of Skills on Wheels on children's MWC skills and confidence in their MWC use. Aim 2 is to investigate the influence of Skills on Wheels on children's psychosocial skills, social participation, and adaptive behavior.

ENROLLING_BY_INVITATION
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Description

Barriers to keeping and maintaining fitness as a young person with a disability exist across many domains of access to community locations such as fitness centers, so looking outside of these establishments may be necessary to advance fitness. This study is aimed at piloting a program that would address some of these barriers by hosting a modified after school running program with an underserved population in an accessible way. There is a second option to participate outside of school.

COMPLETED
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
Description

The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.

COMPLETED
Rehabilitating Corticospinal Control of Walking
Description

The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. The proposed study will test whether training with accurate walking tasks to engage the damaged supraspinal motor pathways is more effective than training with steady state walking. The investigators expect that training accurate tasks will be more effective, thereby improving walking function of Veteran stroke survivors and reducing the burden of care placed on families and on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost to existing rehabilitation approaches, which is important given that the VHA invests $88 million per year toward outpatient care, including physical rehabilitation, in the first six months after stroke. This research also has implications for rehabilitation of other neurologically injured populations, including traumatic brain injury and incomplete spinal cord injury.

Conditions
RECRUITING
Motor Skill Acquisition Between Individuals With Neurological Disorders and Healthy Individuals
Description

Stroke survivors frequently show persistent gait deficits in their chronic stages even after years of intensive rehabilitation. This may be caused by diminished capability of re-acquiring motor skills post stroke. Thus, the overall purpose of this research project is to examine stroke survivors' capability of learning a novel leg task over 3 visits, 1-2 weeks apart. The capability of learning a new skill is then correlated with the individual's neurological functions (nerve activity and movement coordination) and her/his gait performance (gait speed, gait symmetry, and force production).

COMPLETED
Motor Skill Learning in People With Parkinson's Disease
Description

This study will compare brain changes in people with Parkinson's disease with those of normal control subjects while they learn motor skills. People with Parkinson's disease sometimes have trouble learning new skills, but it is not known why. This study will use repetitive transcranial magnetic stimulation (rTMS), nerve conduction studies, and electroencephaolography (EEG) to look for differences in the way the brain changes with learning in people with Parkinson's disease. Healthy normal volunteers and people with Parkinson's disease who are between 21 and 80 years of age may be eligible for this study. Participants undergo the following procedures in five visits to the NIH Clinical Center: Visit 1 Medical and neurological examination. Visit 2 Motor training. Participants perform a pinching movement once every other second, timed to a metronome, during rTMS. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. rTMS involves repeated magnetic pulses delivered in short bursts of impulses. Visits 3 and 4 Brain physiology studies using rTMS, nerve conduction studies (electrical nerve stimulation) and EEG. A nerve at the subject's wrist is stimulated with electrical impulses to measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. rTMS is performed for 20 minutes. The EEG measures the electrical activity of the brain (brain waves). For this test, electrodes (metal discs) are placed on the scalp with a conductive gel and the brain waves are recorded while the subject moves his or her thumb briskly for 20 minutes. Visit 5 Subjects undergo rTMS for 20 minutes and have an EEG. ...

COMPLETED
Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
Description

The investigators aim to identify the effect of a 12-week fundamental motor skills (FMS) (e.g., throwing, catching, running) intervention on the active participation in physical recreation activities and a variety of other factors (child behaviors, communication, and adaptive skills) and to identify patterns, benefits, constraints, and strategies to active participation in physical recreation activities among families of children with autism spectrum disorders (ASD) (pre-post) through in-person or via phone interviews with parents and children with ASD.

COMPLETED
The Effect of Play on Social and Motor Skills of Children With ASD
Description

In this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with Autism Spectrum Disorder (ASD). Recently, the investigators have identified cortical dysfunction patterns as markers of imitation/interpersonal synchrony difficulties in children with ASD using functional near-infrared spectroscopy. In this project, the investigators want to validate whether cortical markers can determine treatment responders and if such markers are sensitive to training-related changes. Following training, the investigators expect to see a variety of behavioral and neural changes in both groups. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. This research will build evidence for the use of various movement interventions for school-age children with ASD.

COMPLETED
Improving Motor Skill Development in Infants After Cardiac Surgery
Description

The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.

COMPLETED
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Description

Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.

COMPLETED
Treatment of Executive Dysfunction in Parkinson's Disease
Description

Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and priority setting). Thus, atomoxetine has the potential to improve executive dysfunction in people with Parkinson's disease (PD). The goal of this study is to provide preliminary data on the effectiveness and tolerability of atomoxetine for the treatment of executive dysfunction in patients with PD.

COMPLETED
Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease
Description

The problems in motor activity associated with Parkinson's disease are still poorly understood. Patients with Parkinson's disease often suffer from extremely slow movements (bradykinesia) which result in the inability to perform complex physical acts. Imaging studies of the brain have provided researchers with information about the specific areas in the brain associated with these motor difficulties. One particular area involved is the surface of the brain called the cerebral cortex. Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, and corpus callosum). Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses. Researchers plan to study the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) on complex motor behavior of patients with Parkinson's disease. In order to measure its effectiveness, patients will be asked to perform complex tasks, such as playing the piano while receiving transcranial magnetic stimulation.

COMPLETED
My Scrivener® - Measuring Effectiveness and Dose Response in Children
Description

This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.

UNKNOWN
Critical Periods After Stroke Study (CPASS)
Description

To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke: * early (initiated within 30 days) * subacute/outpatient (initiated within 2-3 months) * chronic (initiated within 6-9 months) The control group will not receive the therapy intervention during the 1-year study. Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset. Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.

COMPLETED
Dose Optimization for Stroke Evaluation
Description

This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.

COMPLETED
Arm Rehabilitation Study After Stroke
Description

This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage \& content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.