Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

NCT ID: NCT00971451

Last Updated: 2011-03-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-12-31

Brief Summary

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Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.

All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.

Detailed Description

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Conditions

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Rupture of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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knee joint cryotherapy

20 minutes of knee joint cryotherapy - ice bag application

Group Type EXPERIMENTAL

cryotherapy

Intervention Type OTHER

20 minutes of knee joint cryotherapy - ice bag application

TENS

continuous TENS for duration of the 1 hour exercise session

Group Type EXPERIMENTAL

TENS

Intervention Type OTHER

continuous use of TENS during the exercise session

No intervention

no modality intervention; just exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cryotherapy

20 minutes of knee joint cryotherapy - ice bag application

Intervention Type OTHER

TENS

continuous use of TENS during the exercise session

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Complete ACL rupture
2. Age 15-55

Exclusion Criteria

1. Persons who cannot tolerate knee joint TENS.
2. Persons who have a known allergy to cryotherapy
3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia

Principal Investigators

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Joseph M Hart, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joseph M Hart, Ph.D.

Role: CONTACT

434-243-0256

Facility Contacts

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Joseph M Hart, PhD

Role: primary

434-243-0256

Other Identifiers

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13398

Identifier Type: -

Identifier Source: org_study_id

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