Spinal Cord InjuriesNCT00882843
Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With Spinal Cord Injury (SCI)
An observational study of Spinal Cord Injuries, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
In persons with SCI, because of inherent considerations, the use of mechanical stimulation has not been studied to determine improvement in bone mass. To achieve maximum transmission of the vibration from a vibrating plate to the lower body, the legs must be extended and the feet firmly placed against the surface… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2010
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ten ambulatory able-bodied and Twelve non-ambulatory subjects with SCI will be enrolled to participate
Who may be able to join
- Chronic spinal cord injury or healthy able-bodied
- 18+ years of age
Who cannot join
- Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.)
- Flexion contractures of the lower extremities
- Femur or tibia fracture or history of extensive bone trauma
- History of prior bone disease
- Post-menopausal women
- Renal disease (creatinine clearance < 40 ml/min)
Show all 13Show fewer
- Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, hypogonadism)
- Alcoholism
- Seizure disorders
- All pressure ulcers of the sacral/pelvic region, lower extremities, and heels
- Pacemakers, implanted cardiac defibrillators, or any other electrical cardiac device
- Implanted rods placed between 2 or more vertebral segments
- Pregnant women (pregnancy test will be administered when applicable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With SCI
In persons with SCI, because of inherent considerations, the use of mechanical stimulation has not been studied to determine improvement in bone mass. To achieve maximum transmission of the vibration from a vibrating plate to the lower body, the legs must be extended and the feet firmly placed against the surface plate of the device. Thus, these logistical considerations must be addressed to perform this mechanical intervention in persons with SCI. In those with complete or almost complete motor injury, there is lack of musculoskeletal function below the level of the lesion, which would prevent rigid straight leg extension and pressing one's feet against a surface, regardless of the angle of tilt that would permit adequate transmission of impulse in an able-bodied individual (preliminary data). However, in one subject with SCI, there was measurable, albeit low level, transmission of vibration with increasing angles of tilt (preliminary data). Because of the ability to transmit some signal in an individual with complete SCI, the possibility exists that with forms or mechanical support/manipulation, greater signal transmission may be possible. The study will be able to determine the best angle to transmit mechanical vibration through the lower body of SCI patients.
Read the detailed description
Experiments will be performed in 12 persons with SCI and 10 healthy able-bodied to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI. This will entail the following combinations:
- positional modification (sitting, lying or standing if tolerable);
- bracing the knee to prevent flexion/extension;
- bracing the legs above and/or below the knee;
- supporting the ankle;
- tilting the surface (tilt table) to a maximum angle of 45 degrees;
- Standing with the assistance of a standing frame if subject can tolerate standing for 5 minute time periods.
- increasing the magnitude of the plate acceleration (0.2-0.6g); and
- mechanically pressing the legs (ankle and knee joints relatively fixed in position by an orthotic device) against the plate by a spring-loaded method (it is envisioned that a padded belt-like article will be worn around the waist and would be attached with bungee cords (or springs) to each side of the vibrating plate; the maximum force delivered would be equal to 50 lbs or one-third of total body weight, whichever is less).
An accelerometer for the measurement of impulse generation will be placed on the surface of the vibrating plate between the feet; a second will be placed on the shin about 4 inches below the knee (attached with double sided tape and athletic bandage wrap); a third accelerometer will be placed in the mouth as a bite-bar. Measurements would be acquired with combinations of body position, joint/leg fixation, magnitude of plate acceleration ("g" force), and mechanical force pressing the feet against the plate to determine the optimal transmission of impulse.
This study will determine the optimal of the methodology for using the vibrating plate to transmit an impulse in persons with chronic SCI, with the anticipation of its application to increase bone mass in individuals with acute or chronic SCI. It is anticipated that each session will be between 30 and 120 minutes. An individual may voluntarily participate in as many as 5 sessions. The knowledge gained from the first sets of studies will obviate the need to perform less effective methods of mechanical signal transmission in subsequent studies. It is anticipated that once the most effective, as well as clinically applicable, form of mechanical stimulation is identified, it will be performed in most of the subjects. This preliminary study will also provide the information required to determine practical aspects of the length of each session and number of sessions per week in a future intervention trial.
Since this research may have adverse effects on an unborn child and should not be done during pregnancy, we will administer a pregnancy test when appropriate. Subjects will be asked to avoid becoming pregnant and use contraceptives, take precautions against becoming pregnant.
- Conditions
- Spinal Cord Injuries
- Keywords
- Vibrating plate, Mechanical Stimulation, Osteoporosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy Able bodied Control | |
| Group 2 | Spinal Cord Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiments will be to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William Bauman, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882843
- Sponsor's protocol ID
- B4162C-9
- Status last verified
- Jun 2012
- First submitted
- 16 Apr 2009
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With SCI
- ClinicalTrials.gov ID
- NCT00882843
- Acronym / sponsor ID
- B4162C-9
- Conditions
- Spinal Cord Injuries
- Keywords
- Vibrating plate, Mechanical Stimulation, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Apr 2009 (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.
In persons with SCI, because of inherent considerations, the use of mechanical stimulation has not been studied to determine improvement in bone mass. To achieve maximum transmission of the vibration from a vibrating plate to the lower body, the legs must be extended and the feet firmly placed against the surface plate of the device. Thus, these logistical considerations must be addressed to perform this mechanical intervention in persons with SCI. In those with complete or almost complete motor injury, there is lack of musculoskeletal function below the level of the lesion, which would prevent rigid straight leg extension and pressing one's feet against a surface, regardless of the angle of tilt that would permit adequate transmission of impulse in an able-bodied individual (preliminary data). However, in one subject with SCI, there was measurable, albeit low level, transmission of vibration with increasing angles of tilt (preliminary data). Because of the ability to transmit some signal in an individual with complete SCI, the possibility exists that with forms or mechanical support/manipulation, greater signal transmission may be possible. The study will be able to determine the best angle to transmit mechanical vibration through the lower body of SCI patients.
Detailed description
Experiments will be performed in 12 persons with SCI and 10 healthy able-bodied to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI. This will entail the following combinations:
- positional modification (sitting, lying or standing if tolerable);
- bracing the knee to prevent flexion/extension;
- bracing the legs above and/or below the knee;
- supporting the ankle;
- tilting the surface (tilt table) to a maximum angle of 45 degrees;
- Standing with the assistance of a standing frame if subject can tolerate standing for 5 minute time periods.
- increasing the magnitude of the plate acceleration (0.2-0.6g); and
- mechanically pressing the legs (ankle and knee joints relatively fixed in position by an orthotic device) against the plate by a spring-loaded method (it is envisioned that a padded belt-like article will be worn around the waist and would be attached with bungee cords (or springs) to each side of the vibrating plate; the maximum force delivered would be equal to 50 lbs or one-third of total body weight, whichever is less).
An accelerometer for the measurement of impulse generation will be placed on the surface of the vibrating plate between the feet; a second will be placed on the shin about 4 inches below the knee (attached with double sided tape and athletic bandage wrap); a third accelerometer will be placed in the mouth as a bite-bar. Measurements would be acquired with combinations of body position, joint/leg fixation, magnitude of plate acceleration ("g" force), and mechanical force pressing the feet against the plate to determine the optimal transmission of impulse.
This study will determine the optimal of the methodology for using the vibrating plate to transmit an impulse in persons with chronic SCI, with the anticipation of its application to increase bone mass in individuals with acute or chronic SCI. It is anticipated that each session will be between 30 and 120 minutes. An individual may voluntarily participate in as many as 5 sessions. The knowledge gained from the first sets of studies will obviate the need to perform less effective methods of mechanical signal transmission in subsequent studies. It is anticipated that once the most effective, as well as clinically applicable, form of mechanical stimulation is identified, it will be performed in most of the subjects. This preliminary study will also provide the information required to determine practical aspects of the length of each session and number of sessions per week in a future intervention trial.
Since this research may have adverse effects on an unborn child and should not be done during pregnancy, we will administer a pregnancy test when appropriate. Subjects will be asked to avoid becoming pregnant and use contraceptives, take precautions against becoming pregnant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Healthy Able bodied Control |
| Group 2 | – | –Spinal Cord Injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ten ambulatory able-bodied and Twelve non-ambulatory subjects with SCI will be enrolled to participate
Key inclusion criteria (2 listed)
- Chronic spinal cord injury or healthy able-bodied
- 18+ years of age
Key exclusion criteria (13 listed)
- Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.)
- Flexion contractures of the lower extremities
- Femur or tibia fracture or history of extensive bone trauma
- History of prior bone disease
- Post-menopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experiments will be to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI.
Time frame: one day
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 25 Jun 2012.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
William Bauman, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by US Department of Veterans Affairs at 1 site in United States.
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 13 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 25 Jun 2012. 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 United States. 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?
Experiments will be to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI. (time frame: one day). 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 25 Jun 2012.