Spinal Cord Injury.NCT00150683
Effectiveness of Vibration and Standing Versus Standing Alone for the Treatment of Osteoporosis for People With Spinal Cord Injury.
A study testing vibration and passive standing versus passive standing alone in people with Spinal Cord Injury. and Osteoporosis., run by Toronto Rehabilitation Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Spinal Cord Injury., Osteoporosis.
- What is being tested?
- vibration and passive standing versus passive standing alone
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 1999to Jul 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Traumatic spinal cord injury of greater than 12 months.
- Osteopenia or osteoporosis of the hip.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After 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.
- Conditions
- Spinal Cord Injury., Osteoporosis.
- Being tested
- vibration and passive standing versus passive standing alone
- Keywords
- Spinal Cord Injury., Osteoporosis., Standing., Vibration.
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibration and passive standing versus passive standing aloneDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.
Secondary outcomes (3)
Spasticity (modified Ashworth).
Quality of life.
Frequency and severity of adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 1999
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Investigators
- B. Cathy Craven, BPHE, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150683
- Sponsor's protocol ID
- ONBO-99135
- Other IDs
- Ontario Neurotrauma Foundation
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00150683
- Acronym / sponsor ID
- ONBO-99135
- Conditions
- Spinal Cord Injury., Osteoporosis.
- Keywords
- Spinal Cord Injury., Osteoporosis., Standing., Vibration.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Mar 1999
- Study completion
- Jul 2001
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Traumatic spinal cord injury of greater than 12 months.
- Osteopenia or osteoporosis of the hip.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibration and passive standing versus passive standing alone | Device | – |
Primary outcome
Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.
3 secondary outcomes
Spasticity (modified Ashworth).
Quality of life.
Frequency and severity of adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Cathy Craven, BPHE principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibration and passive standing versus passive standing alone in people with Spinal Cord Injury. and Osteoporosis., run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2005.