- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01204736
Comparing Outcomes of Elbow Extension Tendon Transfers
A Comparison of Two Surgical Procedures That Restore Elbow Extension
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Voluntary control of elbow extension significantly improves functional abilities for individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via tendon transfer is considered a fundamental intervention that benefits the patient, even if other tendon transfers aimed at improving hand function are never performed. Presently, there are two common tendon transfer surgeries used to restore elbow extension following spinal cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps transfer. Both surgeries significantly improve voluntary elbow extension, although there is variability in the amount of control that is restored among patients. This study will directly compare the performance of the posterior deltoid transfer to the biceps transfer with regard to: voluntary elbow extension strength, the ability to activate the transfer, and neural factors associated with voluntary and involuntary control of individual muscles. These comparisons will be made in functionally relevant postures and will provide fundamental information that will improve clinical understanding of the capacity of each of these two procedures to restore elbow extension.
The fundamental hypothesis of this proposal is that an inability to maximally activate the transferred posterior deltoid and the transferred biceps significantly limits the elbow extension moment that can be produced.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Illinois
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Hines, Illinois, Vereinigte Staaten, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Cervical Spinal Cord Injury (C5-C7)
- Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery
- Biceps to Triceps Tendon Transfer at least one year post-surgery
Exclusion Criteria:
Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including:
- unhealed decubiti
- use of baclofen pumps
- existing infection
- cardiovascular disease
- significant osteoporosis (as indicated by a history of fractures following injury)
- or a history of pulmonary complications or autonomic dysreflexia
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Group 1
Subjects with posterior deltoid-to-triceps tendon transfers
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Group 2
Subjects with biceps-to-triceps tendon transfers
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Group 3
Subjects with cervical SCI who have not had tendon transfers
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Group 4
Unimpaired control subjects
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Elbow Extension Strength
Zeitfenster: At least one year post surgery
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Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate.
We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions.
Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds.
The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.
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At least one year post surgery
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Wendy M Murray, PhD, Edward Hines Jr. VA Hospital, Hines, IL
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- B7515-R
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