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Effectiveness of Vibration and Standing Versus Standing Alone for the Treatment of Osteoporosis for People With Spinal Cord Injury.

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ClinicalTrials.gov Identifier: NCT00150683
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 8, 2005
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by:
Toronto Rehabilitation Institute

Brief Summary:
The purpose of this study is to find out if standing and/or standing with vibration works for the treatment of osteoporosis for people with a spinal cord injury.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury. Osteoporosis. Device: vibration and passive standing versus passive standing alone Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury
Study Start Date : March 1999
Study Completion Date : July 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.

Secondary Outcome Measures :
  1. Spasticity (modified Ashworth).
  2. Quality of life.
  3. Frequency and severity of adverse events.


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Traumatic spinal cord injury of greater than 12 months.
  • Osteopenia or osteoporosis of the hip.

Exclusion Criteria:

  • Pregnant or lactating females.
  • Nonunion lower extremity fracture within the last 6 months.
  • Bilateral hip or knee flexion contractures.
  • Bilateral lower extremity total hip or knee replacement.
  • Heterotopic ossification of the hip or knee.
  • Concurrent treatment with a bisphosphonate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150683


Locations
Canada, Ontario
Toronto Rehab, Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: B. Cathy Craven, BPHE Toronto Rehabilitation Institute

ClinicalTrials.gov Identifier: NCT00150683     History of Changes
Other Study ID Numbers: ONBO-99135
Ontario Neurotrauma Foundation
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 8, 2005
Last Verified: September 2005

Keywords provided by Toronto Rehabilitation Institute:
Spinal Cord Injury.
Osteoporosis.
Standing.
Vibration.

Additional relevant MeSH terms:
Wounds and Injuries
Osteoporosis
Spinal Cord Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System