Evaluating Muscle Function After Ankle Surgery - Full Text View

Purpose

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	Intervention
Muscle Atrophy Muscle Weakness Fractures	Procedure: Physical Therapy

Genetics Home Reference related topics:

adenosine monophosphate deaminase deficiency

MedlinePlus related topics:

Fractures Rehabilitation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Convenience Sample, Prospective Study

Official Title:	Restoration of Muscle Function During Rehabilitation

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:	30
Study Start Date:	September 1995
Estimated Study Completion Date:	August 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060970

Locations


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)

Investigators


Principal Investigator:	Krista Vandenborne, Ph.D., P.T.	University of Pennsylvania, Department of Physiology

More Information

Click here for more information about the Metabolic Magnetic Resonance Research and Computing Center, University of Pennsylvania This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Elliott MA, Walter GA, Gulish H, Sadi AS, Lawson DD, Jaffe W, Insko EK, Leigh JS, Vandenborne K. Volumetric measurement of human calf muscle from magnetic resonance imaging. MAGMA. 1997 Jun;5(2):93-8.

Vandenborne K, Elliott MA, Walter GA, Abdus S, Okereke E, Shaffer M, Tahernia D, Esterhai JL. Longitudinal study of skeletal muscle adaptations during immobilization and rehabilitation. Muscle Nerve. 1998 Aug;21(8):1006-12.

Elliott MA, Walter GA, Swift A, Vandenborne K, Schotland JC, Leigh JS. Spectral quantitation by principal component analysis using complex singular value decomposition. Magn Reson Med. 1999 Mar;41(3):450-5.

Shaffer MA, Okereke E, Esterhai JL Jr, Elliott MA, Walker GA, Yim SH, Vandenborne K. Effects of immobilization on plantar-flexion torque, fatigue resistance, and functional ability following an ankle fracture. Phys Ther. 2000 Aug;80(8):769-80.

Gregory CM, Vandenborne K, Dudley GA. Metabolic enzymes and phenotypic expression among human locomotor muscles. Muscle Nerve. 2001 Mar;24(3):387-93.

Study ID Numbers:	R29HD33738
First Received:	May 16, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00060970
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Disuse atrophy

Ankle fracture

Exercise, therapy

Cast immobilization

Deconditioning

Sarcopenia

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Signs and Symptoms

Muscular Diseases

Musculoskeletal Diseases

Asthenia

Fractures, Bone

Neurologic Manifestations

Atrophy

Muscle Weakness

Muscular Atrophy

Additional relevant MeSH terms:

Neuromuscular Manifestations

Pathologic Processes

Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00060970