| February 19, 2008 |
| October 16, 2008 |
| July 2008 |
| February 2009 (final data collection date for primary outcome measure) |
| Bone density scan [ Time Frame: within 7 days pre/post intervention ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00624988 on ClinicalTrials.gov Archive Site |
| Single fiber EMG at neuromuscular junction [ Time Frame: 7 days pre/post intervention ] [ Designated as safety issue: No ] |
| Same as current |
| |
| The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury |
| The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury |
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 |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Spinal Cord Injury |
| Procedure: Vibration Therapy |
| Experimental: 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. |
| |
| |
| Recruiting |
| 10 |
| February 2009 |
| February 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00624988 |
| David Lenihan BA., D.C., Ph.D., M.C.C., CBiol MiBiol, FRSM, Logan University, College of Chiropractic |
| RD0723070100 |
| Logan College of Chiropractic |
|
| Principal Investigator: |
David V Lenihan, DC, PhD |
Logan College of Chiropractic |
|
|
| Logan College of Chiropractic |
| October 2008 |
