Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060970
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-05-16
Brief Title:
Evaluating Muscle Function After Ankle Surgery
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Restoration of Muscle Function During Rehabilitation
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None