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| ID | Type | Description | Link |
|---|---|---|---|
| K01HD052713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Rehabilitation | Active Comparator | Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises. |
|
| Standard Rehabilitation + Quadriceps intensive strengthening | Experimental | The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadriceps intensive strengthening | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points. | Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention) |
| Change in Tibial Articular Cartilage Volume | A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume. | Baseline (pre-surgery) to 1 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Single Leg Forward Hop Index | Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100] | 7 weeks post-surgery (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terese Chmielewski, PT, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF & Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida | 32607 | United States |
29 subjects were consented to the study. During pre-surgery (baseline) testing, 2 subjects were found not to have a meniscal tear (inclusion criterion) and were withdrawn from the study. Total number of subjects meeting eligibility criteria was 27.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Rehabilitation | Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises. 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) |
| FG001 | 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. 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. 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The target number of participants was determined statistically from preliminary data on primary outcome measures. The final population was based on feasibility.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Rehabilitation | Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises. 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points. | 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. | Mean | Standard Deviation | units on a scale | Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Rehabilitation | Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises. 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) |
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Difficulty with subject recruitment due to concomitant injury with meniscal tear
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terese Chmielewski | University of Florida | (352)273-6104 | tchm@ufl.edu |
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| Standard rehabilitation | 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) |
|
| Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) |
CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay. |
| Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention) |
| BG001 | 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. 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. 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) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | 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. 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. 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) |
|
|
| Primary | Change in Tibial Articular Cartilage Volume | A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume. | 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. Images were not analyzable for one subject in the Standard+Quadriceps Intensive Strengthening group. | Mean | Standard Deviation | percentage change from baseline | Baseline (pre-surgery) to 1 year post-surgery |
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|
|
| Secondary | Single Leg Forward Hop Index | Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100] | 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. 2 subjects in the Standard Rehabilitation group and 1 subject in the Standard + Quadriceps Intensive Strengthening group did not complete hop testing. | Mean | Standard Deviation | percentage | 7 weeks post-surgery (post-intervention) |
|
|
|
| Secondary | Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay. | 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. | Mean | Standard Deviation | log (ng/mmol) | Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. 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. 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) | 0 | 13 | 0 | 13 |
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