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Effect of Functional Electrical Stimulation in Gluteus Medius in Rehabilitation After Total Hip Arthroplasty (EFESGMRTHA)

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ClinicalTrials.gov Identifier: NCT02861027
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Carolina Sant Anna Umpierres, Federal University of Rio Grande do Sul

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.


Condition or disease Intervention/treatment Phase
OSTEOARTHRITIS Procedure: PPTHA Procedure: FES and PPTHA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Functional Electrical Stimulation in Gluteus Medius in Rehabilitation After Total Hip Arthroplasty: Randomized Clinical Trial
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: PPTHA
Control Group performs the PPTHA.
Procedure: PPTHA
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.

Experimental: FES and PPTHA
The Intervention Group performs the PPTHA associated with FES.
Procedure: PPTHA
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.

Procedure: FES and PPTHA
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.




Primary Outcome Measures :
  1. Anamnesis [ Time Frame: 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. ]
    Composed of the identification data, history of current and history of Pathology progression of pathologies.


Secondary Outcome Measures :
  1. Goniometry [ Time Frame: 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 ]
    Will be performed in accordance with the methodology proposed by Goniometry Manual. Will be assessed by goniometry passive movements of flexion, adduction, abduction, internal and external rotation of the hand operated before and after THA.

  2. Evaluation of muscle strength of gluteus medius [ Time Frame: 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 ]
    Maximum muscle strength of gluteus medius muscle will be evaluated through a portable digital load dynamometer 20 Kilogram force (Kgf), Instrutemp brand, itfg5020 model. With the patient lying supine, the dynamometer is positioned on the underside of the thigh region of the operated limb, next to the patient's knee to score the maximum isometric contraction of abduction and external rotation of the hip, creating a compressive force on the dynamometer. The strength will be measured three times with intervals of 2 minutes of rest between the assessments. The maximum value obtained will be used as the maximum gluteus medius volunteer force.

  3. Functional evaluation of the hip [ Time Frame: 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 ]
    The Harris Hip Score is specific assessment tool designed to assess the results of the ANALYSES, being widely used as a method of comparing the results. Features scale with a maximum of 100 points, including assessment of pain, function,deformity and mobility. Pain and function has the highest weight (44 and 47 points).Range of motion and deformity are of primary importance getting 5 and 4 points respectively. The functionality is subdivided into activities of daily living (14 points) and March (33 points). Total score less than 70 points is considered bad result, 70 to 80 80 to 90 reasonably good and the excellent 100 90.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with Coxarthroses Primary and Secondary with THA indication

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861027


Locations
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Brazil
Federal University Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Carolina S Umpierres, Master Federal University Rio Grande do Sul
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Responsible Party: Carolina Sant Anna Umpierres, Master Degree, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02861027    
Other Study ID Numbers: UFRioGrande
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carolina Sant Anna Umpierres, Federal University of Rio Grande do Sul:
Osteoarthritis
Total hip arthroplasty
Physiotherapy
Functional Electrical Stimulation
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases