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Medial Wedge Insoles to Improve Gait in Persons After Total Hip Replacement

NCT05736016 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-15

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

medial wedge insoles ((corrective insoles are equipped with hard 10-degree medial wedge, while sham insoles are equipped with pliable 10-degree medial wedge)

All study participants will be instructed to use insoles for exercising, walking, and other everyday activities.

Sponsors & Collaborators

  • National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

    lead NETWORK

Principal Investigators

  • Beata Tarnacka, MD PhD · National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736016 on ClinicalTrials.gov