Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00971451

Enrollment

Registered

2009-09-03

Start date

2007-11-30

Completion date

2011-12-31

Last updated

2011-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior cruciate ligament, ACL

Brief summary

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.

Interventions

OTHERcryotherapy

20 minutes of knee joint cryotherapy - ice bag application

OTHERTENS

continuous use of TENS during the exercise session

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Quadriceps muscle strength and inhibition using the quadriceps central activation ratio	Day 15

Secondary

Measure	Time frame
Quadriceps H-reflex testing	Day 15
International Knee Documentation Committee Subjective Knee Joint Evaluation	Day 15
Visual Analog Scale	Day 15
Tegner Activity Rating	Day 15

Countries

United States

Contacts

Primary ContactJoseph M Hart, Ph.D.

jmh3zf@hscmail.mcc.virginia.edu434-243-0256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026