Effects of VibrationVib-FrxNCT01553487
Effects Of Unilateral Forearm Vibration On The Loss Of Muscle And Bone Of Contralateral Forearm
A study testing Forearm vibration in people with Effects of Vibration, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture. A total of 80 patients with forearm/elbow fracture are planned to include in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Effects of Vibration
- What is being tested?
- Forearm vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2013to Mar 2014
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a simple (uncomplicated) forearm/elbow fracture
- Males and females between 18 and 50 years of age
Who cannot join
- Fracture of distal radius
- Multiple previous fractures of bones in the upper extremities
- Complicated fracture (associated skin and/or tendon and/or nerve and/or vascular trauma, fragmented fractures )
- Patients not examined within the first three days after a trauma
- Upper extremity problems
- Orthopedic problems: shortness of arms, congenital abnormalities
Show all 14Show fewer
- Joint disease (arthritis, joint prosthesis, etc.)
- Other painful pathologies in the upper extremities (tendinitis, bursitis, etc.)
- Circulation problems in the upper extremities
- Skin lesions, dermatologic disorders
- Hypertension (>135 mmHg systolic, >85 mmHg diastolic) or Heart disease (coronary dis, conduction/rhythm prob, cardiac pacemaker)
- Neurological diseases (CNS problems, peripheral neuropathy)
- Systemic disease affecting bone metabolism: secondary osteoporosis, osteomalacia, Paget's disease, Diabetes mellitus, hepatic disease, renal dis. etc
- Non-cooperative patients, psychiatric conditions (panic attacks etc)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training & Research Hospital
Istanbul
About this study
Official title: Effects Of Unilateral Forearm Vibration On The Loss Of Muscle Strength And Bone Of The Contralateral Forearm Due to Forearm/Elbow Fracture
The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.
A total of 80 patients with forearm/elbow fracture are planned to include in this study. Patients will be randomly attained Training or Control group. Training period will be six weeks. Patients in the control group will receive standard care for provided for fractures, including fixation and rest.Before the start of the study and after six weeks, bilateral bone density of distal radius will be measured by DXA. Before trials, grip strength and the rest muscle electrical activity of contralateral wrist flexors and extensors will be measured. After six weeks, bilateral grip strength and the rest muscle electrical activity will be measured.
Read the detailed description
The structure of a bone and the muscles surrounding it changes in a temporally synchronized fashion. Skeletal muscles have positive effects on bone structure and function. It is well-known that exercise training of muscles improves the resistance of bone to mechanical loading and that physical activity is also important for treating and preventing osteoporosis. Resistance and impact training can induce bone formation and/or prevent bone resorption. Immobilization frequently leads disuse osteoporosis in patients with a bone fracture.
Vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates osteocytes. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. Based on the bone myoregulation reflex, bone is sensitive to mechanical stimuli and can send mechanical input signals to central nervous system and so can neuronally regulate the muscle activity.
Previous studies have documented the impact of unilateral training of limb muscle on the untrained contralateral homologous muscle.
The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.
The study will include a total of 80 patients with forearm/elbow fractures. The participants meeting inclusion criteria will be randomized into one of two groups: a training group (40 cases) and a control group (40 cases). Patients in the control group will receive standard care for provided for fractures, including fixation and rest.
Forearm Vibration: Training group will exercise 5 times a week for six week period using a forearm vibration device. The forearm vibration device consists of a joystick unit, a weight-pulley system and a control panel. The subject will be seated in a chair. The right forearm will be placed on the vibration device with the shoulder in 10 degrees abduction, the elbow in 90 degrees flexion and the forearm and wrist in the neutral position. The axis of rotation of joystick unit will be aligned with that of the wrist joint of the free arm. The joystick unit will be capable of performing both an angular and a sliding motion simultaneously. The angular motion obtained the vibration effect and the sliding motion obtained the compression effect. The angular motion of the joystick unit will be provided by an electric motor. The range of angular motion will be 6 degrees. The weight is attached to the joystick with a rope and pulley system to provide mechanical loading to the forearm (compression effect). This weight is defined as vibration load. Maximum vibration load tolerated will be applied during vibration. The amplitude of vibration (range of motion of the wrist) will be 6 degree and the frequency of the vibration will be 40 Hz. The exercise duration and intensity will be low at the beginning but increased systematically over the 6-week training period. The subjects will be asked to report negative side effects or adverse reactions in their training diary.
Bone Densitometry: Before trails and after six weeks, bilateral bone density of distal radius will be measured by DXA. The bilateral bone density will be evaluated by bone densitometer (Norland).
Grip Strength Measurement: Before the start of the study, grip strength of wrist muscles in the free limb will be measured. After six weeks, bilateral grip strength will be measured by a hand dynamometer (Jamar digital plus hand dynamometer).
Surface EMG: Surface EMG of the right and left wrist muscles will be recorded using disposable self-adhesive bipolar Ag/AgCl electrodes (Kendall Arbo ) placed on its belly. The small disc electrodes (10-mm in diameter, inter-electrode distance of 20 mm) arranged in the direction of the muscle fibers. All cables will be carefully taped to the skin.
The skin overlying the muscle will be shaved, light abrasion will be applied, the skin will be cleaned using 70% alcohol and, conductive paste will be used to reduce electrode resistance before placing the electrodes.
Motor unit potentials will be amplified and recorded on a computer for off-line analyses at a sampling frequency of 2k using a data acquisition and analysis system (Powerlab data acquisition system, ADInstruments, Australia).
Twenty seconds of myoelectrical activity will be recorded from wrist muscles at rest. The mean myoelectrical activity will be calculated as the root mean squared (RMS) using the EMG device software, and defined as the "resting myoelectrical activity". The resting myoelectrical activity will be expressed as microvolt.
Power spectral analyses will be done. They will be conducted using Hamming windowed, 2048 point epochs, resulting in a frequency resolution of 0.98 Hz.
This is a prospective, randomized, controlled, single blind trial
- Conditions
- Effects of Vibration
- Being tested
- Forearm vibration
- Keywords
- vibration, muscle strength, bone loss, immobilization, fracture
- Medical subject headings
- Bone Diseases, Metabolic, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm vibrationOther
Also called vibration training
All cases will be trained by forearm vibration device 5 times a week for six weeks period.
| Study group | Role | What they receive |
|---|---|---|
| Excercise | Experimental | The forearm vibration training Receives: Other: Forearm vibration |
| Control | No intervention | Patients will be treated by routine fracture treatment methods (fixation and rest). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of forearm muscle strength
Change of muscle strength with forearm vibration
Measured: baseline and 6 weeks
Secondary outcomes (1)
Change of distal radius bone mineral density
Change of distal radius bone mineral density with forearm vibration
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startSep 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: We did not found voluntary subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of VibrationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Study chair, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553487
- Sponsor's protocol ID
- BEAH FTR-6
- Acronym
- Vib-Frx
- Status last verified
- Aug 2013
- First submitted
- 5 Mar 2012
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Unilateral Forearm Vibration On The Loss Of Muscle Strength And Bone Of The Contralateral Forearm Due to Forearm/Elbow Fracture
- ClinicalTrials.gov ID
- NCT01553487
- Acronym / sponsor ID
- Vib-Frx / BEAH FTR-6
- Conditions
- Effects of Vibration
- Keywords
- vibration, muscle strength, bone loss, immobilization, fracture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not found voluntary subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 14 Mar 2012 (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 aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.
A total of 80 patients with forearm/elbow fracture are planned to include in this study. Patients will be randomly attained Training or Control group. Training period will be six weeks. Patients in the control group will receive standard care for provided for fractures, including fixation and rest.Before the start of the study and after six weeks, bilateral bone density of distal radius will be measured by DXA. Before trials, grip strength and the rest muscle electrical activity of contralateral wrist flexors and extensors will be measured. After six weeks, bilateral grip strength and the rest muscle electrical activity will be measured.
Detailed description
The structure of a bone and the muscles surrounding it changes in a temporally synchronized fashion. Skeletal muscles have positive effects on bone structure and function. It is well-known that exercise training of muscles improves the resistance of bone to mechanical loading and that physical activity is also important for treating and preventing osteoporosis. Resistance and impact training can induce bone formation and/or prevent bone resorption. Immobilization frequently leads disuse osteoporosis in patients with a bone fracture.
Vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates osteocytes. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. Based on the bone myoregulation reflex, bone is sensitive to mechanical stimuli and can send mechanical input signals to central nervous system and so can neuronally regulate the muscle activity.
Previous studies have documented the impact of unilateral training of limb muscle on the untrained contralateral homologous muscle.
The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.
The study will include a total of 80 patients with forearm/elbow fractures. The participants meeting inclusion criteria will be randomized into one of two groups: a training group (40 cases) and a control group (40 cases). Patients in the control group will receive standard care for provided for fractures, including fixation and rest.
Forearm Vibration: Training group will exercise 5 times a week for six week period using a forearm vibration device. The forearm vibration device consists of a joystick unit, a weight-pulley system and a control panel. The subject will be seated in a chair. The right forearm will be placed on the vibration device with the shoulder in 10 degrees abduction, the elbow in 90 degrees flexion and the forearm and wrist in the neutral position. The axis of rotation of joystick unit will be aligned with that of the wrist joint of the free arm. The joystick unit will be capable of performing both an angular and a sliding motion simultaneously. The angular motion obtained the vibration effect and the sliding motion obtained the compression effect. The angular motion of the joystick unit will be provided by an electric motor. The range of angular motion will be 6 degrees. The weight is attached to the joystick with a rope and pulley system to provide mechanical loading to the forearm (compression effect). This weight is defined as vibration load. Maximum vibration load tolerated will be applied during vibration. The amplitude of vibration (range of motion of the wrist) will be 6 degree and the frequency of the vibration will be 40 Hz. The exercise duration and intensity will be low at the beginning but increased systematically over the 6-week training period. The subjects will be asked to report negative side effects or adverse reactions in their training diary.
Bone Densitometry: Before trails and after six weeks, bilateral bone density of distal radius will be measured by DXA. The bilateral bone density will be evaluated by bone densitometer (Norland).
Grip Strength Measurement: Before the start of the study, grip strength of wrist muscles in the free limb will be measured. After six weeks, bilateral grip strength will be measured by a hand dynamometer (Jamar digital plus hand dynamometer).
Surface EMG: Surface EMG of the right and left wrist muscles will be recorded using disposable self-adhesive bipolar Ag/AgCl electrodes (Kendall Arbo ) placed on its belly. The small disc electrodes (10-mm in diameter, inter-electrode distance of 20 mm) arranged in the direction of the muscle fibers. All cables will be carefully taped to the skin.
The skin overlying the muscle will be shaved, light abrasion will be applied, the skin will be cleaned using 70% alcohol and, conductive paste will be used to reduce electrode resistance before placing the electrodes.
Motor unit potentials will be amplified and recorded on a computer for off-line analyses at a sampling frequency of 2k using a data acquisition and analysis system (Powerlab data acquisition system, ADInstruments, Australia).
Twenty seconds of myoelectrical activity will be recorded from wrist muscles at rest. The mean myoelectrical activity will be calculated as the root mean squared (RMS) using the EMG device software, and defined as the "resting myoelectrical activity". The resting myoelectrical activity will be expressed as microvolt.
Power spectral analyses will be done. They will be conducted using Hamming windowed, 2048 point epochs, resulting in a frequency resolution of 0.98 Hz.
This is a prospective, randomized, controlled, single blind trial
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excercise | Experimental | Other: Forearm vibrationThe forearm vibration training |
| Control | No intervention | –Patients will be treated by routine fracture treatment methods (fixation and rest). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with a simple (uncomplicated) forearm/elbow fracture
- Males and females between 18 and 50 years of age
Key exclusion criteria (14 listed)
- Fracture of distal radius
- Multiple previous fractures of bones in the upper extremities
- Complicated fracture (associated skin and/or tendon and/or nerve and/or vascular trauma, fragmented fractures )
- Patients not examined within the first three days after a trauma
- Upper extremity problems
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 |
|---|---|---|
| Forearm vibrationAlso: vibration trainingAll cases will be trained by forearm vibration device 5 times a week for six weeks period. | Other | Excercise |
Primary outcome
Change of forearm muscle strength
Time frame: baseline and 6 weeks
Change of muscle strength with forearm vibration
1 secondary outcome
Change of distal radius bone mineral density
Time frame: baseline and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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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.
ILHAN KARACAN, MD study chair
Bagcilar Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm vibration in people with Effects of Vibration, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 14 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: withdrawn, as of the sponsor's last update on 14 Aug 2013. 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 Turkey (Türkiye). 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 was withdrawn before enrolling participants, so there are no results.
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 of forearm muscle strength (time frame: baseline and 6 weeks). 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 14 Aug 2013.