Osteoporosis Clinical Trial
— ERAMNEOfficial title:
Effect of Radius Subjecting to Mechanical Loading on Alpha Motor Neuron Excitability
| Verified date | August 2013 |
| Source | Vakif Gureba Training and Research Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ministry of Health |
| Study type | Interventional |
This study hypothesize that radius subjecting to mechanical loading may affect excitability
of alpha motor neuron innervating muscle, based on its bone mineral density. If this
hypothesis is valid, it can be firstly suggested that the relationship between bone mineral
density and muscle strength is bidirectional.
A total of 80 voluntaries are planned to include in this study.
After forearm vibration is applied, bone mineral density (BMD) and bone mineral content
(BMC) will be measured in all cases. Alpha motor neuron excitability (H/M ratio,
recruitment), background muscle activity will be evaluated by electromyography at
pre-treatment, post-treatment and, during treatment in cases.
Forearm vibration will be applied by forearm vibration device (FAV). FAV with mechanical
loading will apply forearm. Cases will sit on armchair. Two intervals of FAV will be applied
at a frequency of 45 Hz. Each interval will consist of 60 second of FAV followed by rest.
The right radius BMD and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).
Motor unite potentials at rest, Hoffman reflex, F response, M response will be measured by
electromyography at right flexor carpi radialis. Medtronic Keypoint Portable 2 channel
electromyography and Neurotrac ETS device will be used.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | December 2009 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - females with postmenopausal osteoporosis (forearm BMD: T score <-2.0) - females without postmenopausal osteoporosis (forearm BMD: T score >-1.0) - healthy young adult females (forearm BMD normal) - healthy young adult males (forearm BMD normal) - cases with right handed patients in all groups Exclusion Criteria: - secondary osteoporosis - neuropathy (central or peripheral) - myopathy - systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases) - professional sportswoman/sportsman - subjects doing regular sports activities - tendinopathy - amputee, endoprosthesis, metal implants |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Vakif Gureba Training & Research Hospital | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Vakif Gureba Training and Research Hospital |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changing alpha motor neuron excitability | 1-2 months | No |
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