Risk of Falls in Patients With Fibromyalgia (FM)
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|ClinicalTrials.gov Identifier: NCT01823796|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : December 10, 2014
Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms: fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. The prevalence has been reported to be between 2 and 5%.
The hypothesis of this study is that women with fibromyalgia present high risk of falls and balance disorders compared with healthy women. The objective of this study was to investigate wether gait pattern changes in single and dual task conditions were associated with the risk of falling in women with fibromyalgia.
|Condition or disease||Intervention/treatment|
|Fibromyalgia||Other: Fibromyalgia women group Other: Healthy women|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Assessment of Balance and Risk of Falls in Women With Fibromyalgia|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2013|
35 healthy women. Control group.
Other: Healthy women
These women are assessed in order to be compared with fibromyalgia women group.
Other Name: Control group
Fibromyalgia women group
35 women with fibromyalgia were measured at baseline of the observational study.
Other: Fibromyalgia women group
Assessment of this group at baseline in order to be compared with a control group.
Other Name: Fibromyalgia
- Timed up & Go (TUG) [ Time Frame: baseline ]
This test timed in seconds measure the time taken by the participant to stand up from an arm chair, walk 3 metres at normal pace, turn around, walk back and sit down. They start to the order of "Go!" A stopwatch was used to measure the time. The TUG is a frequently used test to assess mobility and fall risks in older adults and is recommended by American Geriatrics Society (2011) as a screening tool.
The timed up and go combined with a cognitive task was also measured.
- Functional reach test [ Time Frame: baseline ]It is a quick and simple test. It score the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position. The subject is asked to reach forward as far as possible without taking a step or touching the wall. It measure the ability of maintain balance during a functional task. It has been shown to be predictive of falls. It was tested with a tape measure on the wall using the head of the metacarpal of the third finger as the reference point.
- Single leg stance [ Time Frame: baseline ]This is a frequently clinical tool used to assess balance and postural steadiness. In the start position the person stand erect with arm folded across chest and the head facing straight ahead; shoes off. The subject is asked to lift one leg off the floor, based on preference of subject and keep the leg raised as long as possible without touching the other leg. Timer is stopped whether the subject's raised foot either touches the floor, makes contact with other leg or moves the stance foot to create a new base of support,if the arms move out of the test position or when a maximum balance time of 30s take place. The time was measured with a stopwatch.
- Tinetti Test [ Time Frame: baseline ]This test evaluated 13 tasks and permit the assessment of the static and dynamic balance.
- Barthel Index [ Time Frame: baseline ]Clinical application tool of 10 items that can be administered in 2-5 minutes by a member of the medical staff or self-administered in about 10 minutes. It measure the ability to achieve certain activities without help
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823796
|Faculty of Health Sciences. University of Granada.|
|Granada., Granada, Spain, 18071|
|Principal Investigator:||Marie Carmen Valenza, PhD||Universidad de Granada|