Acute Injury of Anterior Cruciate Ligament Clinical Trial
Official title:
Can Neuromuscular Training Alter Movement Patterns After Anterior Cruciate Ligament Injury?
| NCT number | NCT01773317 |
| Other study ID # | 225014-1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2011 |
| Est. completion date | August 28, 2018 |
| Verified date | July 2019 |
| Source | University of Delaware |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A prospective randomized controlled trial will be used to evaluate the efficacy of post-operative perturbation training. 80 patients who were regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 13-55 at the time of injury are eligible. All eligible subjects must undergo primary anterior cruciate ligament reconstruction. Using a prospective randomized design, 40 subjects who will be block randomized by sex to 40 patients who will receive 10 sessions of post-operative perturbation training in addition to standard agility and return to activity progression and forty who receive only standard agility and return to activity progression. Post-operative perturbation training will be initiated when the athlete is at least 12 weeks post-anterior cruciate ligament reconstruction, has full range of motion and achieves 80% quadriceps strength symmetry, the criteria we currently use for beginning return to activity progression.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | August 28, 2018 |
| Est. primary completion date | August 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years to 55 Years |
| Eligibility |
At this time, subjects have been enrolled and we are no longer recruiting for this study. Inclusion Criteria: - regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury - ages 13-55 at the time of injury - undergo primary Anterior Cruciate Ligament reconstruction Exclusion Criteria: - concomitant Grade III ligament tears - osteochondral defects >1cm2 - history of previous Anterior Cruciate Ligament Reconstruction or other major lower extremity injury/surgery |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Delaware, Physical Therapy Department | Newark | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Lynn Snyder-Mackler |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in gait patterns from baseline to completion of intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction and 2 years after anterior cruciate ligament reconstruction | Motion analysis data of gait patterns will be collected to analyze gait movement patterns of individuals after anterior cruciate ligament reconstruction and over time. | At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 year after anterior cruciate ligament reconstruction | |
| Secondary | Quadriceps Strength | At enrollment (baseline), After protocol intervention (approximately 6 months after surgery),1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction | ||
| Secondary | Patient reported outcomes (Knee Outcomes Survey-Activity of Daily Living Scale, Global Rating Score of Perceived Knee Function, Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000 Subjective Knee Form) | At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction | ||
| Secondary | Single-legged hop measures | At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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