Trial Outcomes & Findings for Muscle Weakness and Post-traumatic Knee OA (NCT NCT01879852)
NCT ID: NCT01879852
Last Updated: 2014-10-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
Results posted on
2014-10-01
Participant Flow
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During pre-surgery (baseline) testing, 2 subjects were found not to have a meniscal tear (inclusion criterion) and were withdrawn from the study.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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Muscle Weakness and Post-traumatic Knee OA
Baseline characteristics by cohort
| Measure |
Standard Rehabilitation
n=14 Participants
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)
|
Standard Rehabilitation + Quadriceps Intensive Strengthening
n=13 Participants
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)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
18.3 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
20.4 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
176.9 cm
STANDARD_DEVIATION 8.5 • n=5 Participants
|
180.1 cm
STANDARD_DEVIATION 8.8 • n=7 Participants
|
178.5 cm
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Weight
|
78.7 kg
STANDARD_DEVIATION 13.2 • n=5 Participants
|
100.9 kg
STANDARD_DEVIATION 30.1 • n=7 Participants
|
89.8 kg
STANDARD_DEVIATION 26.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)Population: 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.
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.
Outcome measures
| Measure |
Standard Rehabilitation
n=12 Participants
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)
|
Standard Rehabilitation + Quadriceps Intensive Strengthening
n=13 Participants
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)
|
|---|---|---|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
|
22.2 units on a scale
Standard Deviation 21.6
|
20.6 units on a scale
Standard Deviation 21.1
|
PRIMARY outcome
Timeframe: Baseline (pre-surgery) to 1 year post-surgeryPopulation: 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.
A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.
Outcome measures
| Measure |
Standard Rehabilitation
n=12 Participants
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)
|
Standard Rehabilitation + Quadriceps Intensive Strengthening
n=11 Participants
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)
|
|---|---|---|
|
Change in Tibial Articular Cartilage Volume
|
0.18 percentage change from baseline
Standard Deviation 3.21
|
-1.24 percentage change from baseline
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: 7 weeks post-surgery (post-intervention)Population: 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.
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 \[(distance on the surgical side/distance on the non-surgical side) \*100\]
Outcome measures
| Measure |
Standard Rehabilitation
n=10 Participants
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)
|
Standard Rehabilitation + Quadriceps Intensive Strengthening
n=12 Participants
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)
|
|---|---|---|
|
Single Leg Forward Hop Index
|
87.1 percentage
Standard Deviation 15.2
|
90.1 percentage
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)Population: 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.
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.
Outcome measures
| Measure |
Standard Rehabilitation
n=12 Participants
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)
|
Standard Rehabilitation + Quadriceps Intensive Strengthening
n=13 Participants
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)
|
|---|---|---|
|
Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
|
0.01 log (ng/mmol)
Standard Deviation 0.18
|
-0.11 log (ng/mmol)
Standard Deviation 0.13
|
Adverse Events
Standard Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Rehabilitation + Quadriceps Intensive Strengthening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place