Evaluating Muscle Function After Ankle Surgery

Muscle Weakness Clinical Trial

Official title:

Restoration of Muscle Function During Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060970
• Other study ID #: R29HD033738
• Status: Completed
• Phase: N/A
• First received: May 16, 2003
• Last updated: June 23, 2005
• Start date: September 1995
• Est. completion date: August 2000

Study information

• Verified date: March 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Fractures
• Muscle Atrophy
• Muscle Weakness
• Muscular Atrophy
• Paresis

Intervention

Procedure:
• Physical Therapy

Locations

Country	Name	City	State
United States	MMRRCC, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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