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Evaluating Muscle Function After Ankle Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060970
Recruitment Status : Completed
First Posted : May 19, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
Patients who are forced to rest or reduce activity as a result of illness, injury, or surgery often experience resulting muscle weakness. This study will evaluate muscle features and muscle strength in patients who are recovering from surgery for broken ankles. The goal of this study is to improve the recovery of muscle function and overall ability after prolonged periods of ankle inactivity due to surgery.

Condition or disease Intervention/treatment
Muscle Atrophy Muscle Weakness Fractures Procedure: Physical Therapy

Detailed Description:

Many physiological conditions are associated with muscle weakness and can affect movement. This study will investigate which metabolic and morphological features of skeletal muscle are uniquely altered during the course of rehabilitation and how they affect muscle function and performance in daily ambulatory activities. This study will also examine how well the commonly used assessment measures reflect actual muscle capacity. Finally, because there is evidence that activity does not affect all fiber types uniformly, fiber-type specific metabolic and morphological measures will be performed.

Participants in this study will have had an ankle injury that has been treated surgically (Open Reduction Internal Fixation, or ORIF) followed by 5 to 10 weeks of cast immobilization. Following initial baseline measurements made after 1 week of re-ambulation, participants are enrolled in a 10-week rehabilitation program that focuses on restoration of both muscle strength and endurance. Assessments are made at Weeks 5 and 10 and include 31P-Magnetic Resonance Spectroscopy (MRS), Magnetic Resonance Imaging (MRI), muscle biopsy, and muscle function and functional performance tests. 31P-measurements monitor changes in the in vivo metabolic characteristics of skeletal muscle. 3D-MRI procedures will be used to quantify the maximal muscle cross-sectional area and total muscle volume. Muscle endurance and strength will be measured using an isokinetic dynamometer. Functional performance tests consist of self-selected walking pace, power for ascending and descending stairs, and toe raises while standing on one foot.

Nine participants (six patients and three control volunteers) will be studied each year. Control volunteers are submitted to the same measurements at similar time intervals in order to assess variability over time.

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Study Type : Observational
Enrollment : 30 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Restoration of Muscle Function During Rehabilitation
Study Start Date : September 1995
Study Completion Date : August 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 5 to 10 weeks of cast immobilization following surgery (ORIF) for mallerolar fracture

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Severe claustrophobia
  • MRI incompatible metal implants (e.g., pacemaker)
  • Diabetes or peripheral neuropathies
  • Bleeding disorders

Information from the National Library of Medicine

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 identifier (NCT number): NCT00060970

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United States, Pennsylvania
MMRRCC, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Krista Vandenborne, Ph.D., P.T. University of Pennsylvania, Department of Physiology
Additional Information:
Layout table for additonal information Identifier: NCT00060970    
Other Study ID Numbers: R29HD033738 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2003
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Disuse atrophy
Ankle fracture
Exercise, therapy
Cast immobilization
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Atrophy
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms