NCT01553487

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

March 5, 2012

Last Update Submit

August 13, 2013

Conditions

Effects of Vibration

Keywords

vibrationmuscle strengthbone lossimmobilizationfracture

Outcome Measures

Primary Outcomes (1)

  • Change of forearm muscle strength

    Change of muscle strength with forearm vibration

    baseline and 6 weeks

Secondary Outcomes (1)

  • Change of distal radius bone mineral density

    baseline and 6 weeks

Study Arms (2)

Excercise

EXPERIMENTAL

The forearm vibration training

Other: Forearm vibration

Control

NO INTERVENTION

Patients will be treated by routine fracture treatment methods (fixation and rest).

Interventions

Forearm vibrationOTHER

All cases will be trained by forearm vibration device 5 times a week for six weeks period.

Also known as: vibration training
Excercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a simple (uncomplicated) forearm/elbow fracture
  • Males and females between 18 and 50 years of age

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicFractures, Bone

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • ILHAN KARACAN, MD

    Bagcilar Training & Research Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associated Professor

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 14, 2012

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

TU(1)