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

Spinal Cord Injury. Clinical Trial

Official title:

Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150683
• Other study ID #: ONBO-99135
• Secondary ID: Ontario Neurotra
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: March 1999
• Est. completion date: July 2001

Study information

• Verified date: September 2005
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis.
• Spinal Cord Injuries
• Spinal Cord Injury.

Intervention

Device:
• vibration and passive standing versus passive standing alone

Locations

Country	Name	City	State
Canada	Toronto Rehab, Lyndhurst Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.
Secondary	Spasticity (modified Ashworth).
Secondary	Quality of life.
Secondary	Frequency and severity of adverse events.