Influence of Medial Wedge Corrective Insoles Versus Sham Insoles on Gait Characteristics in Persons After Total Hip Replacement - Randomized Control Trial
Sponsor study identifier
interventional
100
0 countries
N/A
Study Start
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2023
Actual (reported)February 21, 2023
Actual (reported)February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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.
All study participants will be instructed to use insoles for exercising, walking, and other everyday activities.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Beata Tarnacka, MD PhD
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
First Submitted
February 9, 2023
First Posted
February 21, 2023
Study Start
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Contact the study team to confirm eligibility.
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Klotzbier TJ, Schott N. Cognitive-Motor Interference during Walking in Older Adults with Probable Mild Cognitive Impairment. Front Aging Neurosci. 2017 Dec 11;9:350. doi: 10.3389/fnagi.2017.00350. eCollection 2017.
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Mendiolagoitia L, Rodriguez MA, Crespo I, Del Valle M, Olmedillas H. Kinematic Gait Analysis After Primary Total Hip Replacement: A Systematic Review: Gait After Total Hip Replacement: A Systematic Review. Indian J Orthop. 2020 Apr 16;54(6):767-775. doi: 10.1007/s43465-020-00101-x. eCollection 2020 Nov.
McCrory JL, White SC, Lifeso RM. Vertical ground reaction forces: objective measures of gait following hip arthroplasty. Gait Posture. 2001 Oct;14(2):104-9. doi: 10.1016/s0966-6362(01)00140-0.
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Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 15, 2023
Record last verified: 2023-11
All of the individual participant data collected during the trial, after deidentification will be made published on Open Science Framework.
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