NCT02861027

Brief Summary

Due to the importance of the functions of the gluteus medium, mainly during gait, it becomes essential to strengthening early in the musculature. The association of muscle strengthening with the Functional Electric Stimulation (FES) comes to accelerate stabilization of hip, leading to functional rehabilitation early and improves the quality of life through rehabilitation in social life and activities of daily life. Thus, it becomes a relevant study to assess objectively the implications of FES in muscle strengthening of gluteus medium associated with the Physiotherapy Protocol Total Hip Arthroplasty (PPTHA), through the assessment of motor performance in patients undergoing surgery for Total Hip Arthroplasty (THA), aiming to better rehabilitation strategies for this population. The objective of the research is to assess the effects of functional rehabilitation through PPTHA associated with FES in the gluteus medium compared only with the PPTHA, in patients undergoing surgery for THA. The principal hypothesis is that there is difference between the functional rehabilitation of the patients undergoing PPTHA associated with the FES of gluteus medium, after THA and the patients submitted only to PPTHA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

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

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 19, 2015

Last Update Submit

August 4, 2016

Conditions

Keywords

OsteoarthritisTotal hip arthroplastyPhysiotherapyFunctional Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Anamnesis

    Composed of the identification data, history of current and history of Pathology progression of pathologies.

    The assessment is held a day before the surgery and in the fourth or fifth day in hospital discharge. The time between assessment and reassessment is up to five days.

Secondary Outcomes (3)

  • Goniometry

    The assessment is held a day before the surgery and in the fourth or fifth day in hospital discharge. The time between assessment and reassessment is up to five days

  • Evaluation of muscle strength of gluteus medius

    The assessment is held a day before the surgery and in the fourth or fifth day in hospital discharge. The time between assessment and reassessment is up to five days

  • Functional evaluation of the hip

    The assessment is held a day before the surgery and in the fourth or fifth day in hospital discharge. The time between assessment and reassessment is up to five days

Study Arms (2)

PPTHA

ACTIVE COMPARATOR

Control Group performs the PPTHA.

Procedure: PPTHA

FES and PPTHA

EXPERIMENTAL

The Intervention Group performs the PPTHA associated with FES.

Procedure: PPTHAProcedure: FES and PPTHA

Interventions

PPTHAPROCEDURE

The control group will receive Protocol Physiotherapeutic Total Hip Arthroplasty (PPTHA), consisting of guidelines on the care and post THA. The PPTHA, is held once a day, for 60 minutes, accompanied by a physiotherapist and has the following composition: 1 day) oral guidance and exercise to strengthen the gluteal muscles and muscles of the thigh, with recommendation for 3 repetitions of 12 movements, for each financial year. Patients are encouraged to sit outside the bed, after the exercises; Day 2) patients perform exercises the first day and begin the March training, with the aid of a Walker or crutches Canadians for the room; Day 3) patients perform exercises and are encouraged to walk in the hallway of the hospital wing. Day 4) reassessment and discharge.

FES and PPTHAPPTHA
FES and PPTHAPROCEDURE

The PPTHA associated with FES. The stimulation protocol of FES is performed with the patient positioned in supine position in bed. After cleaning the skin, two electrodes are positioned in the posterolateral region of the thigh in motor point of the medium gluteus muscle. The total time for application of the apparatus 30 min per day totaling more 1 min per day as suggested in specialized references. The intensity is adjusted according to the tolerance of the patient. The apparatus used is wavelength Ibramed Neurodyn Compact.

FES and PPTHA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Coxarthroses Primary and Secondary with THA indication

You may not qualify if:

  • patients who refused to participate in this study,
  • patients with indication for THA by fractures and bone tumors,
  • THA review,
  • anatomic abnormalities congenital and acquired,
  • patients with neurologist lesions that do not understand the commands or with changes in sensitivity in lower limbs
  • patients with postoperative infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Carolina S Umpierres, Master

    Federal University Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

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
Master Degree

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 10, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations