NCT00060970

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2003

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2003

First QC Date

May 16, 2003

Last Update Submit

June 23, 2005

Conditions

Muscle AtrophyMuscle WeaknessFractures

Keywords

Disuse atrophyAnkle fractureExercise, therapyCast immobilizationDeconditioningSarcopenia

Interventions

Physical TherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 10 weeks of cast immobilization following surgery (ORIF) for mallerolar fracture

You may not qualify if:

  • Pregnant or breastfeeding
  • Severe claustrophobia
  • MRI incompatible metal implants (e.g., pacemaker)
  • Diabetes or peripheral neuropathies
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MMRRCC, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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. doi: 10.1007/BF02592238.

    PMID: 9268071BACKGROUND

  • 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.

    PMID: 9655118BACKGROUND

  • 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.

    PMID: 10204865BACKGROUND

  • 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.

    PMID: 10911415BACKGROUND

  • 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.

    PMID: 11353424BACKGROUND

Related Links

MeSH Terms

Conditions

Muscular AtrophyMuscle WeaknessFractures, BoneMuscular Disorders, AtrophicAnkle FracturesMotor ActivitySarcopenia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesPathologic ProcessesWounds and InjuriesNeuromuscular DiseasesAnkle InjuriesLeg InjuriesBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Krista Vandenborne, Ph.D., P.T.

    University of Pennsylvania, Department of Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 16, 2003

First Posted

May 19, 2003

Study Start

September 1, 1995

Study Completion

August 1, 2000

Last Updated

June 24, 2005

Record last verified: 2003-03

Locations

US(1)