NCT01804608

Brief Summary

Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip muscle strengthening versus hip muscle strengthening and sensory motor training in lower limbs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 28, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

February 28, 2013

Last Update Submit

October 24, 2016

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Function and pain intensity

    4 weeks

Secondary Outcomes (3)

  • Muscle strength of the hip and knee muscles

    4 weeks

  • Three-dimensional kinematics of the trunk and lower limbs during the step down task

    4 weeks

  • Function and pain intensity

    3 and 6 months after randomization

Study Arms (2)

Sensorimotor

EXPERIMENTAL

Sensorimotor, this arm will receive sensorimotor and hip muscle strengthening.

Other: Sensorimotor

Strength

ACTIVE COMPARATOR

Strength, this arm will receive only hip muscle strengthening.

Other: Strength

Interventions

StrengthOTHER
Also known as: Hip abductors and lateral rotators and knee extensors strengthening
Strength
SensorimotorOTHER
Also known as: Sensorimotor, balancing exercises, motor coordination, proprioceptive stimuli.
Sensorimotor

Eligibility Criteria

Age18 Years - 30 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

Location

Related Publications (1)

  • Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.

    PMID: 24884455DERIVED

Related Links

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

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

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 5, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

BR(1)