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

Not Applicable

Completed

• Conditions: Spinal Cord Injury.; Osteoporosis.

• Registration Number: NCT00150683
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-03
• Study Completion: 2001-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Last Update Submitted: 2005-09-06
• Study First Posted: 2005-09-08
• Last Update Posted: 2005-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.

Secondary Outcome Measures

Name	Time	Method
Spasticity (modified Ashworth).
Quality of life.
Frequency and severity of adverse events.

Trial Locations

Locations (1)

Toronto Rehab, Lyndhurst Centre; 🇨🇦 Toronto, Ontario, Canada