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

Primary Purpose

Spinal Cord Injury., Osteoporosis.

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

vibration and passive standing versus passive standing alone

About this trial

This is an interventional treatment trial for Spinal Cord Injury. focused on measuring Spinal Cord Injury., Osteoporosis., Standing., Vibration.

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Toronto Rehab, Lyndhurst Centre

Outcomes

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.

Full Information

NCT ID

NCT00150683

First Posted

September 6, 2005

Last Updated

September 6, 2005

Sponsor

Toronto Rehabilitation Institute

Collaborators

Ontario Neurotrauma Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00150683

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

March 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Toronto Rehabilitation Institute

Collaborators

Ontario Neurotrauma Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury., Osteoporosis.

Keywords

Spinal Cord Injury., Osteoporosis., Standing., Vibration.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

vibration and passive standing versus passive standing alone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Spasticity (modified Ashworth).

Title

Quality of life.

Title

Frequency and severity of adverse events.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

B. Cathy Craven, BPHE

Organizational Affiliation

Toronto Rehabilitation Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Rehab, Lyndhurst Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3V9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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