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Evaluating Muscle Function After Ankle Surgery
This study has been completed.
Study NCT00060970   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: May 16, 2003   Last Updated: June 23, 2005   History of Changes

May 16, 2003
June 23, 2005
September 1995
 
 
 
Complete list of historical versions of study NCT00060970 on ClinicalTrials.gov Archive Site
 
 
 
Evaluating Muscle Function After Ankle Surgery
Restoration of Muscle Function During Rehabilitation

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.

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.

 
Observational
Natural History, Longitudinal, Convenience Sample, Prospective Study
  • Muscle Atrophy
  • Muscle Weakness
  • Fractures
Procedure: Physical Therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
August 2000
 

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060970
 
R29HD33738
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Krista Vandenborne, Ph.D., P.T. University of Pennsylvania, Department of Physiology
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP