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Freehand Ultrasound to Evaluate Scapular Kinematics in People With Paraplegia - FUS

Freehand Ultrasound to Evaluate Scapular Kinematics in People With Paraplegia

Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder during routine daily activities, the onset of pain or injury lead to increased healthcare expenses, limitation in activity, depression, decreased participation, and reduced quality of life. One of the main reasons of shoulder pain is believed to have a altered scapular movement. To clarify the mechanism of the shoulder pain and injury, comprehensive understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture system to evaluate scapular movement was developed and presented favorable results in able-bodied population. The purpose of this study is to compare the FUS and widely used skin-based method against a radiographic based gold standard in people with paraplegia, and to elucidate the relationship among scapular movement and shoulder pain, pathology. This study will also allow us to gain more understanding of how level of injury influences the scapular behavior during functional activities. The investigators believe more severe shoulder pain and pathology will be associated with greater abnormal scapular movement. The investigators also believe that people with high-level paraplegia will have greater scapular abnormality than people with low-level paraplegia during arm elevation and weight relief raise tasks. By completing this study, the investigators will expect to deliver a reliable and valid tool to evaluate scapular movement and gain a better understanding how the altered scapular movement is related to shoulder pain and pathology. The investigators will also learn how the level of injury affects the scapular behavior during functional activities. The results of this study may help the shoulder pain management leading to the improvement in the quality of life of individuals with SCI.

NCT02357914 — Spinal Cord Injuries
Status: Active, not recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT02357914/

Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5 - SPA-M

Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5

The purpose of this project is to study the efficacy of three candidate molecules (Xenbilox, Tahor and Resveratrol) in order to decrease the production of oxysterols by reducing the synthesis of cholesterol and/or regulate the production of bile acids and/or enabling neuroprotective action within the motor neuron.

NCT02314208 — Spastic Paraplegia, Hereditary
Status: Completed
http://inclinicaltrials.com/spastic-paraplegia-hereditary/NCT02314208/

Reciprocating Gait Orthoses for Paraplegia Patients - UPGO

NSC Assistive Technology Research: Reciprocating Gait Orthoses for Paraplegia Patients

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.

NCT02227407 — Spinal Cord Injury
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injury/NCT02227407/

Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia - CME-LEM1

Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord

The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.

NCT01909154 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT01909154/

The ReWalk Exoskeletal Walking System for Persons With Paraplegia - VA_ReWalk

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury.

NCT01454570 — Paraplegia
Status: Completed
http://inclinicaltrials.com/paraplegia/NCT01454570/

Effects of Exercise in People With Paraplegia

Exercise Treatment of Obesity-Related Secondary Conditions in Adults With Paraplegia

This hypothesis-driven study will investigate effects of physical activity with or without a nutrient supplement known to increase body lean mass in adults with chronic paraplegia who have clusters of obesity and obesity-related secondary complications.

NCT01203150 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT01203150/

Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis

Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia

Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).

NCT00838838 — Osteoporosis
Status: Completed
http://inclinicaltrials.com/osteoporosis/NCT00838838/

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

Clinical and Genetic Analysis of Autosomal Recessive Forms of Cerebellar Ataxias and Spastic Paraplegias

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.

NCT00140829 — Spastic Paraplegias
Status: Recruiting
http://inclinicaltrials.com/spastic-paraplegias/NCT00140829/

Orthostatic Tolerance During FES (Functional Electrical Stimulation)-Walking in Paraplegia

Orthostatic Tolerance During FES-evoked Stepping in Paraplegia: A Safety and Viability Study

Objective: The objective of this research is to undertake a safety and viability study of FES-evoked stepping in individuals with paraplegia. The rationale for this objective is based upon the need to clarify whether physiological limitations, especially orthostatic intolerance, limit functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors governing orthostatic tolerance during skin-surface FES stepping will be investigated, since this functional task forms the basis of upright mobility and engenders strong physiological challenges upon key regulatory processes in the SCI (spinal cord injury) patient. Specific Hypotheses: i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.

NCT00108043 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT00108043/

Nuclear Magnetic Spectroscopy Imaging to Evaluate Primary Lateral Sclerosis, Hereditary Spastic Paraplegia and Amyotrophic Lateral Sclerosis

Nuclear Magnetic Spectroscopy for the Evaluation of Primary Lateral Sclerosis, Hereditary Spastic Paraplegia and Amyotrophic Lateral Sclerosis

This study will use a magnetic resonance imaging technique called nuclear magnetic spectroscopy (H-MRS) to define the pathology and progression of primary lateral sclerosis, hereditary spastic paraplegia and amyotrophic lateral sclerosis and assess the usefulness of this technique in evaluating patients' response to therapy. H-MRS will be used to examine metabolic changes in the parts of the brain and spinal cord (motor cortex and corticospinal tract) involved in movement. Normal volunteers and patients with primary lateral sclerosis, hereditary spastic paraplegia or amyotrophic lateral sclerosis between 21 and 65 years of age may be eligible for this study. Participants will have up to five H-MRS studies, including baseline and follow-up tests. For this procedure, the subject lies on a stretcher that is moved into a strong magnetic field. Earplugs are worn to muffle the loud knocking noise that occurs during switching of radio frequencies. The subject will be asked to lie still during each scan, for 1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45 and 90 minutes. Communication with the medical staff is possible at all times during the scan.

NCT00023075 — Amyotrophic Lateral Sclerosis
Status: Completed
http://inclinicaltrials.com/amyotrophic-lateral-sclerosis/NCT00023075/