Spinocerebellar Atrophy |
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Clinical Trial: Evaluating Muscle Function After Ankle Surgery
This study has been completed.
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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 | Treatment or Intervention |
|---|---|
| Muscle Atrophy Muscle Weakness Fractures | Procedure: Physical Therapy |
MedlinePlus related topics: Fractures; Muscle Disorders; Neurologic Diseases
Study Type: Observational
Study Design: Natural History, Longitudinal, Convenience Sample, Prospective Study
Official Title: Restoration of Muscle Function During Rehabilitation
Expected Total Enrollment: 30
Study start: September 1995; Study completion: August 2000
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 above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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
Location Information
Pennsylvania
MMRRCC, University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Krista Vandenborne, Ph.D., P.T., Principal Investigator, 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
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.
Record last reviewed: March 2003
Last Updated: October 25, 2004
Record first received: May 16, 2003
ClinicalTrials.gov Identifier: NCT00060970
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Ataxia (National Institute of Neurological Disorders and Stroke)

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