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

This study has been completed.
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00150683
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention
Spinal Cord Injury.
Osteoporosis.
 Device: vibration and passive standing versus passive standing alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

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

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

Estimated Enrollment: 60
Study Start Date: March 1999
Estimated Study Completion Date: July 2001
  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150683     History of Changes
Other Study ID Numbers: ONBO-99135, Ontario Neurotrauma Foundation
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013