NCT02591680

Brief Summary

Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 26, 2015

Last Update Submit

October 28, 2015

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (2)

  • 3D kinematic range of motion of hip adduction during ascending and descending stairs

    Kinematic analysis during ascent and descent stairs

    4 weeks

  • 3D kinematic range of motion of hip internal rotation during ascending and descending stairs

    Kinematic analysis during ascent and descent stairs

    4 weeks

Secondary Outcomes (3)

  • Pain Scores on the Numerical Pain Rating Scale

    4 weeks

  • Strength of hip and knee extensor muscles measured through hand-held dynamometer

    4 weeks

  • Lower Limb Function measured through the questionnaires Anterior Knee Pain Scale -AKPS and Functional Index Questionnaire- FIQ .

    4 weeks

Study Arms (2)

Neuromuscular training

EXPERIMENTAL

Neuromuscular, this arm will receive neuromuscular training and muscle strengthening.

Other: Neuromuscular trainingDevice: Sensorimotor

Strength

ACTIVE COMPARATOR

Strength, this arm will receive only muscle strengthening.

Other: Muscle strengthening

Interventions

Neuromuscular trainingOTHER
Also known as: Sensorimotor, balancing exercises, proprioceptive stimuli.
Neuromuscular training
Muscle strengtheningOTHER
Also known as: Hip abductors and lateral rotators and knee extensors strengthening
Strength
SensorimotorDEVICE
Neuromuscular training

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary women,
  • previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping

You may not qualify if:

  • Lower limb surgery,
  • patella displacement
  • knee instability
  • Heart or locomotor disorders which might influence the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 02020000, Brazil

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Paulo Lucareli

CONTACT

551126339327

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 29, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

BR(1)