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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).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in Turkey (Türkiye)

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

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 groups in NCT01553487
Study groupRoleWhat they receive
ExcerciseExperimentalThe forearm vibration training
Receives: Other: Forearm vibration
ControlNo interventionPatients 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.

  1. Change of forearm muscle strength

    Change of muscle strength with forearm vibration

    Measured: baseline and 6 weeks

Secondary outcomes (1)
  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.

  1. First posted14 Mar 2012 (estimated)
  2. Study startSep 2013
  3. Primary completionFeb 2014 (estimated)
  4. Study completionMar 2014 (estimated)

Why it stopped: We did not found voluntary subjects

Resources

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)
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

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.

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