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Effect of Early Range of Motion Following First Time Patellar Dislocation

Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04294199
Enrollment
60
Registered
2020-03-04
Start date
2018-10-31
Completion date
2026-08-11
Last updated
2023-12-18

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

Conditions

Patellar Dislocation

Brief summary

Do teen-age patients with a dislocated knee cap do better with or without a brace?

Detailed description

This study will look at two different ways to treat teen-age patients who have had a dislocation of their knee cap. Both groups will receive the physical therapy treatment for knee cap dislocation but one group will first be in a brace for a week and the other group will start moving in therapy right away.

Interventions

Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Male and female adolescents between 11-17 years * Medical diagnosis of 1st time lateral patellar instability episode (dislocation or subluxation) * Subjective history of knee shifting, instability, popping out, knee effusion * Apprehension test is positive and has medial patellar tenderness * Referred to the Texas Children's Hospital (TCH) outpatient sports medicine clinic from an emergency room facility, urgent care or pediatrician within 10 days of the injury. * Free of co-morbidities that would prevent or limit rehabilitation including cardiac, pulmonary, psychiatric (except Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD), orthopedic, neurological * Must be able to follow directions and participate in rehabilitation protocol for the 3-month study period.

Exclusion criteria

* Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.

Design outcomes

Primary

MeasureTime frameDescription
Tegner Activity Scale5 minutes11 levels of activity from complete inability to function to advanced sports participation
Kujala Knee Score10 minutes13 item questionnaire to rate pain, function, ambulation, and instability
Isokinetic Strength using Biodex30 minutesForce of movement is measured in newtons and torque and corrected for body weight
Passive Range of Motion5 minutesMeasured with goniometer to record full range of motion in knee flexion and extension
Edema Assessment2 minutesMeasure of knee circumference

Secondary

MeasureTime frameDescription
Numerical Pain Rating Scale1 minutePain rated by patient on scale of 0-10.

Countries

United States

Outcome results

None listed

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