Muscle Weakness and Post-traumatic Knee OA

NCT ID: NCT01879852

Last Updated: 2014-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-08-31

Brief Summary

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This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.

Detailed Description

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Conditions

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Meniscectomy

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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Standard Rehabilitation

Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.

Group Type ACTIVE_COMPARATOR

Standard rehabilitation

Intervention Type BEHAVIORAL

Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)

Standard Rehabilitation + Quadriceps intensive strengthening

The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.

Group Type EXPERIMENTAL

Quadriceps intensive strengthening

Intervention Type BEHAVIORAL

Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.

Standard rehabilitation

Intervention Type BEHAVIORAL

Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)

Interventions

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Quadriceps intensive strengthening

Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.

Intervention Type BEHAVIORAL

Standard rehabilitation

Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. traumatic onset meniscal tear (i.e. specific mechanism of injury)
2. meniscectomy surgery performed within 12 months of index injury
3. meniscal tear confirmed at the time of surgery
4. subject anticipates living in close proximity to Gainesville for one year following surgery.

Exclusion Criteria

1. bilateral injury
2. concomitant ligamentous injury
3. previous knee injury
4. articular cartilage defect \> Grade II on Outerbridge scale
5. patellofemoral joint pain \> 3/10 with activity
6. lower limb alignment \> 5 degrees of valgus or varus
7. contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terese Chmielewski, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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K01HD052713

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00060374

Identifier Type: -

Identifier Source: org_study_id

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