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Evaluating Muscle Function After Ankle Surgery

NCT ID: NCT00060970

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-09-30

Study Completion Date

2000-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Atrophy Muscle Weakness Fractures

Keywords

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Disuse atrophy Ankle fracture Exercise, therapy Cast immobilization Deconditioning Sarcopenia

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Interventions

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Physical Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Krista Vandenborne, Ph.D., P.T.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Department of Physiology

Locations

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MMRRCC, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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. doi: 10.1007/BF02592238.

Reference Type BACKGROUND
PMID: 9268071 (View on PubMed)

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. doi: 10.1002/(sici)1097-4598(199808)21:83.0.co;2-c.

Reference Type BACKGROUND
PMID: 9655118 (View on PubMed)

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. doi: 10.1002/(sici)1522-2594(199903)41:33.0.co;2-9.

Reference Type BACKGROUND
PMID: 10204865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10911415 (View on PubMed)

Gregory CM, Vandenborne K, Dudley GA. Metabolic enzymes and phenotypic expression among human locomotor muscles. Muscle Nerve. 2001 Mar;24(3):387-93. doi: 10.1002/1097-4598(200103)24:33.0.co;2-m.

Reference Type BACKGROUND
PMID: 11353424 (View on PubMed)

Related Links

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http://www.siuh.edu

Click here for more information about the Metabolic Magnetic Resonance Research and Computing Center, University of Pennsylvania

Other Identifiers

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R29HD033738

Identifier Type: NIH

Identifier Source: org_study_id

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