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

NCT05736016 | Unknown

• 1 other identifier: STATUT 2020-Reh
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Total hip replacement; Gait; Insoles; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Mean change from baseline in pain according to Pain Rating Scale by the British Pain Society on numeric rating scales at 12 weeks

  Pain Rating Scale by the British Pain Society, the Polish version; © The British Pain Society 2006 is a self-reported instrument assessing pain intensity (now and on average last week), distress produced by pain (now and on average last week) and interference of pain with everyday activities. The result is presented on five numeric rating scales ranging from 0 (no pain/distress/interference) to 10 (worst possible pain/distress/interference). Change: (week 12 score - baseline score)

  At baseline and on 12 week

• Mean change from baseline in pain, stiffness, and physical functional disability according to Western Ontario and McMaster Universities - WOMAC scale on 12 weeks

  WOMAC scale is a self-reported instrument assessing pain, stiffness, and physical functional disability . The results are presented on a numeric scale between 0 (no symptoms, full physical functionning) and 96 (extremely intensive symptoms, extreme disability). Change: (week 12 score - baseline score)

  At baseline and on 12 week

• Mean change from baseline in osteoarthritis-specific symptoms and physical functional disability according to Lequesne OA index on 12 weeks

  Lequesne OA index is a self-reported instrument assessing osteoarthritis-specific symptoms and physical functional disability. The results are presented on a numeric scale between 0 (no symptoms, full physical functioning) and 24 (extremely intensive symptoms and the worst functioning). Change: (week 12 score - baseline score)

  At baseline and on 12 week

Secondary Outcomes (38)

• Mean change from baseline in range of motion of lower extremities on 6 weeks

  At baseline and on 6 week

• Mean change from baseline in range of motion of lower extremities on 12 weeks

  At baseline and on 12 week

• Mean change from baseline in voluntary gait speed on 6 weeks

  At baseline and on 6 week

• Mean change from baseline in voluntary gait speed on 12 weeks

  At baseline and on 12 week

• Mean change from baseline in step time symmetry on 6 weeks

  At baseline and on 6 week

Study Arms (2)

Active Therapy

ACTIVE COMPARATOR

Active comparator will undergo a 6-week 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, with treadmill walking training being a mandatory part of the program. The rehabilitation program will also address individual needs with psychotherapy and vocational therapy. Follow-up period will be 6 weeks. For the time of the treatment and follow-up period the treatment arm will be provided with individually made corrective medial wedge insoles to be used during all therapeutic and other everyday activities.

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)

Sham Therapy

SHAM COMPARATOR

Sham comparator arm will undergo a 6-week 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, with treadmill walking training being a mandatory part of the program . The rehabilitation program will also address individual needs with psychotherapy and vocational therapy. Follow-up period will be 6 weeks. For the treatment and follow-up the control arm will be provided with individually made sham insoles to be used during all therapeutic and other everyday activities.

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)

Interventions

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

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

Active Therapy; Sham Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of primary or secondary hip coxarthrosis or proxmal hip facture
• Total Hip replacement made from posterior or lateral surgical approaches
• Total Hip replacement made less 1-6 months prior to study entry

You may not qualify if:

• Total Hip replacement made from anterior or anterolateral approach
• Total Hip replacement made less than 1 month or more than 6 months prior to study entry
• 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

Sponsors & Collaborators

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland: lead

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MeSH Terms

Conditions

Femoral Fractures; Osteonecrosis; Hip Dislocation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Joint Diseases; Hip Injuries

Study Officials

• Beata Tarnacka, MD PhD

  National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

  STUDY DIRECTOR

Central Study Contacts

Piotr Tederko, MD PhD FEBPRM

CONTACT

+48506663718; tederko.pl@gmail.com

Daniel Szewczyk, MS

CONTACT

+48515853485; daniels8@wp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants are provided with either active or shame medical devices. Care providers (rehabilitatin team members) and outcome assessors are not acknowledged about patiens' allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: double-blind sham-controlled single-centre randomized study

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.