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

This study has been completed.

Sponsors and Collaborators:	Toronto Rehabilitation Institute Ontario Neurotrauma Foundation
Information provided by:	Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:	NCT00150683

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

MedlinePlus related topics: Osteoporosis Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury

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

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

Keywords provided by Toronto Rehabilitation Institute:

Spinal Cord Injury.
Osteoporosis.
Standing.
Vibration.

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Musculoskeletal Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Osteoporosis
Bone Diseases, Metabolic
Trauma, Nervous System
Bone Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009