Mirror Therapy as an Adjunct to Rehabilitation Following Total Knee Arthroplasty

Обзор

The investigators are looking to see if using a mirror during knee exercises after a knee replacement helps participants with less pain and/or better knee range of motion.

Подробное описание

Purpose: To examine the effectiveness of mirror therapy combined with standard care physical therapy on knee range of motion (ROM), pain levels, and physical function in individuals following a total knee arthroplasty (TKA).

Background: Following a TKA, patients often present with numerous impairments including joint stiffness, pain, decreased strength, and impaired mobility. These limitations can inhibit functional progress during rehabilitation and recovery. Mirror therapy is a potential treatment option that may assist in reducing these impairments and improving recovery following TKA.

Study Activities: Active and sham group activities will add-on to the physical therapy session and are considered part of standard care, with no change to the current billing process. Both groups will participate in ROM activities, consistent with standard PT care, as part of a billable treatment. The active group with do standard practice ROM activities while looking at a mirror and the sham group will perform ROM activities without a mirror.

Interventions:

* Treatment will start within 2 weeks (14 days) of the total knee replacement. * There will be 8 sessions within a 4-week time frame.

Data Analysis: Demographic information will be reported using descriptive statistics. Analyses will use linear mixed-effects models with fixed effects for Group, Time, and the Group × Time interaction, and with subject-level random effects to account for repeated measures. The primary inference will be the Group × Time interaction.

Вмешательства

• Другое Mirror Therapy
  Using a mirror while participating in ROM activities.
• Другое Sham Intervention
  Using a covered mirror, unable to see reflection. subject will perform all ROM activities

Первичные конечные точки

• Pain NRS (Pain Numerical Rating Scale) [Срок оценки: Every visit, visits 1, 2, 3, 4, 5, 6, 7 & 8. Visits start within 14 days of the TKA and occur a total of 8 times within a 4 weeks time frame.]
• Knee Flexion and Extension Goniometry [Срок оценки: Every visit, visits 1, 2, 3, 4, 5, 6, 7 & 8. Visits start within 14 days of the TKA and occur a total of 8 times within a 4 weeks time frame.]

Вторичные конечные точки (2)

• Gait Speed [Срок оценки: Visit 1 and visit 8. Visits start within 14 days of the TKA and occur a total of 8 times within a 4 weeks time frame.]
• Knee Injury and Osteoarthritis Outcome Score, Junior (KOOS Jr) [Срок оценки: Visit 1 and visit 8. Visits start within 14 days of the TKA and occur a total of 8 times within a 4 weeks time frame.]

Критерии участия

Критерии включения

• Candidates that have been screened and deemed eligible for a TKA and received a TKA 14 days or less post operation.
• English speaking
• Able to understand and follow instructions
• Has at least 5 degrees of knee extension to 100 degrees of knee flexion AROM on the contralateral knee
• Able to perform unilateral stance on contralateral side for at least 5 seconds (balance assistance allowed)
• Able to perform exercises

Критерии исключения

• Post-surgical complications (DVT, infection, nerve injury, vascular injury)
• Pain rating on NPRS no more than a 4/10 on the contralateral LE
• Significant scar or deformity of the contralateral LE
• Visual impairments causing an inability to see the reflection in a mirror

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Toshmniwal, P., Wani, Dr. S., Mungikar, Dr. S., Garg, Dr. K., & Katage, Dr. G. (n.d.). Effectiveness of mirror therapy in adjunct to conventional physiotherapy on pain, instability, joint mobility, and proprioception in patients with post anterior cruciate ligament reconstruction surgery: a randomized controlled trial. Neuro Quantology, 20(9), 5954-5960.
• Ramachandran VS, Rogers-Ramachandran D, Cobb S. Touching the phantom limb. Nature. 1995 Oct 12;377(6549):489-90. doi: 10.1038/377489a0. No abstract available. PMID 7566144
• Frenkel MO, Maltese S, Mayer J, Thermann H. Does mental practice supplemented by mirror therapy promote flexion ability after total knee endoprosthesis? Physical Medicine and Rehabilitation Research. 2018;3(2):1-10.
• Ray L. Joint Replacement Surgery. rheumatology.org. Published February 2024. https://rheumatology.org/participants/joint-replacement-surgery
• Rebne E, Louw A, Podalak J, et al. Mirror Therapy for Total Knee Arthroplasty: A Pilot Study. Surgery Research Journal. 3(1):1-9.
• Nishi K, Moriuchi T, Okamura R, Hasegawa T, Chang X, Matsumoto S, Koseki H, Higashi T. Mirror Therapy Reduces Pain and Preserves Corticomotor Excitability in Human Experimental Skeletal Muscle Pain. Brain Sci. 2024 Feb 23;14(3):206. doi: 10.3390/brainsci14030206. PMID 38539595

Идентификаторы

NCT: NCT07380958 · 2384397-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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