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Paraplegia clinical trials

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NCT ID: NCT02314221 Recruiting - Spinal Cord Injury Clinical Trials

Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI

EAWSCI
Start date: February 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to achieve successful walking skills using exoskeletal walking devices over the course of 36 sessions in 3 months at specific velocities and distances in people with chronic SCI who are wheelchair dependent for community mobility. The secondary objectives are to determine if this amount of exoskeletal walking is effective in improving bowel function and body composition in the same patient population. The exploratory objectives are to address additional questions concerning the retention or non-retention of the positive changes, the effects of the increased physical activity from this intervention on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels, and quality of life (QOL). A Phase III randomized clinical trial (RCT) will be performed using a crossover design and employing an exoskeletal-assisted walking intervention. The experimental arm will be compared to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6 month post injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions for their second 12-week period. The UA arm will consist of identification of usual activities for each participant, encouragement to continue with these activities and attention by study team members throughout the 12-week UA arm. These activities will be recorded in a weekly log. The investigators hypotheses are that 1) this exoskeletal intervention will be successful in training ambulatory skills in this patient population, 2) the exoskeletal intervention will be better than a control group in improving body composition, bowel function, metabolic parameters and quality of life in the same population.

NCT ID: NCT02227407 Recruiting - Spinal Cord Injury Clinical Trials

Reciprocating Gait Orthoses for Paraplegia Patients

UPGO
Start date: August 2013
Phase: N/A
Study type: Interventional

Ambulation would bring many physiological and psychological benefits and getting up and walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for paraplegics particularly draws research attentions because it mimics human gait pattern.But, the high energy consumption and low walking speeds caused the frequent abandonment or the low utilization of the reciprocating gait orthoses.To improve the design reducing the energy expenditure, it requires biomechanical analysis of the pathological gait such that the gait deviations and energy consuming mechanisms can be identified and remedial means can be implemented. The investigators hypotheses will include that there would exist an energy saving mechanism of human reciprocating locomotion based on the principle of conservation of mechanical energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy saving mechanism. Finally, the control of knee joint coordinating with the hip joint movements would facilitate the gait progression and further reduce the energy consumption. The objective of this clinical trial is to evaluate the gait of paraplegic patients with reciprocating gait orthoses and to support the investigators research in biomechanical analysis, design and control of reciprocating gait orthoses for paraplegia patients. An experiment to study the pathological gait of paraplegia patients with an existing reciprocating gait orthosis will be carried out.

NCT ID: NCT01568658 Recruiting - Clinical trials for Muscular Dystrophies

Genetic and Physical Study of Childhood Nerve and Muscle Disorders

Start date: March 20, 2012
Phase:
Study type: Observational

Background: - Some nerve and muscle disorders that start early in life (before age 25), like some forms of muscular dystrophy, can run in families. However, the genetic causes of these disorders are not known. Also, doctors do not fully understand how symptoms of these disorders change over time. Researchers want to learn more about genetic nerve and muscle disorders that start in childhood by studying affected people and their family members, as well as healthy volunteers. Objectives: - To better understand nerve and muscle disorders that start early in life and run in families. Eligibility: - Individuals at least 4 weeks old with childhood-onset muscular and nerve disorders, including those who have a later onset of a disorder that typically has childhood onset. - Affected and unaffected family members of the individuals with muscular and nerve disorders. - Healthy volunteers at least 4 weeks old with no nerve or muscle disorders. Design: - Participants will be screened with a physical exam and medical history. Genetic information will be collected from blood, saliva, cheek swab, or skin samples. Urine samples may also be collected. - Healthy volunteers and unaffected family members will have imaging studies of the muscles. These studies will include magnetic resonance imaging (MRI) and ultrasound scans. Results will be compared with those from the affected participants. - All participants with nerve and muscle disorders will have multiple tests, including the following: - Imaging studies of the muscles, including ultrasound and MRI scans. - Imaging studies of the bones, such as x-rays and DEXA scans. - Heart and lung function tests. - Eye exams. - Nerve and muscle electrical activity tests and biopsies. - Video and photo image collection of affected muscles. - Speech, language, and swallowing evaluation. - Lumbar puncture to collect spinal fluid for study. - Tests of movement, attention, thinking, and coordination. - Participants with nerve and muscle disorders will return to the Clinical Center every year. They will repeat the tests and studies at these visits....

NCT ID: NCT01474148 Recruiting - Spinal Cord Injury Clinical Trials

A Neuroprosthesis for Seated Posture and Balance

Trunk Protocol
Start date: November 30, 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

NCT ID: NCT00957762 Recruiting - Diabetes Mellitus Clinical Trials

Body Composition Assessment in Spinal Cord Injury

Start date: August 2009
Phase: N/A
Study type: Observational

The purpose of this research is to evaluate different methods of measuring body composition (amount of fat, muscle, bone, and water in your body) and to determine relationships between body composition and other medical problems associated with spinal cord injury (SCI).

NCT ID: NCT00785278 Recruiting - Paraplegia Clinical Trials

Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion

Start date: July 2008
Phase: N/A
Study type: Observational

Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion. The purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). The primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs. The hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). The overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.

NCT ID: NCT00623389 Recruiting - Stroke Clinical Trials

Evaluation of an Advanced Lower Extremity Neuroprostheses

LE-IST
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

NCT ID: NCT00140829 Recruiting - Spastic Paraplegias Clinical Trials

SPATAX: Clinical and Genetic Analysis of Cerebellar Ataxias and Spastic Paraplegias

Spatax
Start date: July 2003
Phase: Phase 1
Study type: Observational

Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very heterogeneous. More than 40 loci are already known but the number of phenotypes is even greater suggesting further genetic heterogeneity. These progressive disorders are often severe and fatal, due to the absence of specific therapy. The SPATAX network combines the experience of European clinicians and scientists working on these groups of diseases. Over the past year, they have assembled the largest collection of families and achieved a number of tasks (initiation of a clinical and genetic database, distribution of DNA to participating laboratories, mapping of three new loci, and refinement of several loci). In addition to clinicians from Europe and Mediterranean countries, who play a major role in collecting families according to evaluation tools developed and validated by the SPATAX members, the group includes major European laboratories devoted to the elucidation of the molecular basis of these disorders. Each laboratory will centralize all families with a subtype of autosomal recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the responsible gene(s). Genome-wide scans are already underway in 61 families. Given the expertise of the participants, the researchers expect to map and identify several genes during the course of this project. The spectrum of mutations and phenotype/genotype correlations will be analysed thanks to this unique series of patients with various phenotypes. The knowledge gained will be immediately applicable to patients in terms of improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term, models for genetic entity will be developed in order to understand the pathophysiology and to identify new targets for treatment. The series of patients assembled and the precise knowledge of natural history will facilitate the implantation of therapeutic trials based on rational approaches.