NCT00624988UnknownPhase 1
The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
Logan College of Chiropractic3 sites in 1 country10 target enrollmentStarted: July 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- Bone density scan
Study Overview
Brief Summary
The purpose of this investigation is to determine the effect of lower limb vibration therapy on bone density in the tibia in patients with spinal cord injury. The second purpose is to assess the neuromuscular junction variability at the motor units of the tibialis anterior muscle after a sequence of lower limb vibration therapy
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over the age of 18 years
- •A spinal cord injury patient with injury above T12
- •Injury below T4 to avoid respiratory complication.
- •An ASIA classification of A or B
Exclusion Criteria
- •Non complicating organic factors such as heart disease, high blood pressure, stroke
- •Exercise where electrical therapy is used while the trial is being conducted
- •A bone density measure 3 times below normal mineralization levels as measured on the first bone density scan prior to entry in to the study
- •Surgical implants below the level of T12
- •Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
- •Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
- •Acute thrombosis
- •Severe migraine, epilepsy
- •Serious cardiovascular disease, wearing a pacemaker
- •Any Spinal manipulation within one year of the study
- •Any implanted device or prosthesis or intrauterine IUD type of device pregnancy
Outcomes
Primary Outcomes
Bone density scan
Time Frame: within 7 days pre/post intervention
Secondary Outcomes
- Single fiber EMG at neuromuscular junction(7 days pre/post intervention)
Investigators
Study Sites (3)
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