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Effects of Electrical Stimulation and Vitamin D Supplementation on Bone Health Following Spinal Cord Injury

ClinicalTrials.gov · COMPLETED, 2024

6 participants

Abstract

Neurogenic osteoporosis is a common complication of spinal cord injury (SCI) that is associated with low impact bone fractures. It is concerning that more than 46,000 Veterans affected with SCI and are at risk of osteoporosis and possible low impact fractures. About fifty percent of all individuals with SCI will develop low impact fracture in their life time. The management of osteoporosis-related fractures can impose substantial economic burden on the health care system, the individual and the families. Previous studies did not succeed in reversing the process of bone loss after SCI. In the present pilot study, we will evaluate the effect of Neuromuscular Electrical Stimulation Resistance Training in combination with oral Vitamin D supplementation, on bone quality in Veterans with chronic SCI, using a randomized experimental design.

Conditions: Spinal Cord Injury.

Primary outcome: Change in Trabecular Plate Width (Tb.PW) for Femur and Tibia at 4.5 Months; Change in Trabecular Plate Width (Tb.PW) for Femur and Tibia at 9 Months; Change in Trabecular Spacing (Tb.Sp) for Femur and Tibia at 4.5 Months; Change in Trabecular Spacing (Tb.Sp) for Femur and Tibia at 9 Months; Change in Trabecular Network Area Density (Tb.NA) Measured in mm^2/mm^3) at 4.5 Months; Change in Trabecular Network Area Density (Tb.NA) as Measured by MRI at 9 Months.

Enrollment: 6 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 6 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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