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OpenTrials
Completed

NCT Number: NCT00150683

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

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.

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Key information

Conditions

Spinal Cord Injury. Bone Diseases Bone Diseases, Metabolic Central Nervous System Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis. Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vibration and passive standing versus passive standing alone

Device

Primary outcomes

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

Secondary outcomes

  1. Spasticity (modified Ashworth).

  2. Quality of life.

  3. Frequency and severity of adverse events.

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Ontario Neurotrauma Foundation

Registry information

Official study title

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

Important dates

Study start
1999
Study completion
2001
First posted
Sep 8, 2005
Registry last updated
Sep 8, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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