The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
SCI
1 other identifier
interventional
10
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2008
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedOctober 17, 2008
October 1, 2008
7 months
February 19, 2008
October 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone density scan
within 7 days pre/post intervention
Secondary Outcomes (1)
Single fiber EMG at neuromuscular junction
7 days pre/post intervention
Study Arms (1)
Vibration Therapy
EXPERIMENTALTreatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
Interventions
Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Logan College of Chiropractic
Chesterfield, Missouri, 63006, United States
Logan College of Chiropractic
Chesterfield, Missouri, 63017, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David V Lenihan, DC, PhD
Logan College of Chiropractic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2008
First Posted
February 28, 2008
Study Start
July 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
October 17, 2008
Record last verified: 2008-10