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Not Yet Recruiting NCT05736016

Medial Wedge Insoles to Improve Gait in Persons After Total Hip Replacement - Randomized Control Trial

Conditions: Arthritis of Hip, Fracture of Femur, Aseptic Necrosis, Dysplasia; Hip, Surgical Procedure, Unspecified

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Summary

The study will test the hypothesis, that the use of medial wedge insoles in people participating in comprehensive rehabilitation between 1-6 months after total hip replacement, and not having a varus deformity of the knee or symptomatic arthrosis of the medial knee compartment, will improve patient's functioning, the symmetry of gait and stance compared to persons using sham insoles.The participants will undergo a 6-week program of in-patient rehabilitation aimed at: pharmacologic and non-pharmacologic pain management, improvement of vascular function, cardiopulmonary function, functions of skeletal muscles, range of motion and stability of peripheral joints, gait function, body position. The rehabilitation program will also address individual needs with psychotherapy and vocational therapy.The study will help to identify correlations between gait parameter change and functional improvement during the rehabilitation following THR.Study participants will be provided with individually made corrective medial wedge insoles or sham insoles and instructed to use them during gait training and everyday activities.Functional parameters will be examined at the study entry, at the end of 6 weeks of intervention, and 6 weeks following discharge.

Eligibility Criteria

Inclusion Criteria:Total Hip replacement made from posterior or lateral surgical approaches 1-6 months prior to study entryExclusion Criteria:Total Hip replacement made from anterior or anterolateral approach Varus knee (Q angle below 5 degrees in males and below 10 degrees in females Symptomatic arthritis of medial compartment of the knee Use of corrective insoles (excluding insoles for limb length discrepancy compensation) Inability to walk for one minute Neurologic conditions History of hip prosthesis dislocation Cognitive dysfunction (MoCa Score below 26) Lack of shoes with a stiff heel counter

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05736016). StuddyBuddy aggregates publicly available trial information.