- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07380958
Mirror Therapy as an Adjunct to Rehabilitation Following Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marissa Hanlon, PT, DPT, GCS, CSCS
- Phone Number: 315-464-6892
- Email: hanlonma@upstate.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham, no mirror provided
Subjects will participate in ROM activities, consistent with standard PT care, without a mirror
|
Using a covered mirror, unable to see reflection.
subject will perform all ROM activities
|
|
Experimental: Active mirror
Subjects will participate in ROM activities, consistent with standard PT care, with a mirror
|
Using a mirror while participating in ROM activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain NRS (Pain Numerical Rating Scale)
Time Frame: 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.
|
Subject rates pain from 0-10 with 0 being no pain and 10 being the worst pain
|
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
Time Frame: 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.
|
A measurement of knee flexion and knee extension, using a goniometer, will be completed.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Speed
Time Frame: 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.
|
Subject's gait speed will be measured in meters/second.
|
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)
Time Frame: 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) is a short, 7-question survey used by doctors to quickly assess a patient's knee pain, stiffness, and daily function.
The raw score is converted to a 0-100 scale with a score of 0 = total disability and 100 = full function without pain.
|
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.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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, V. S., et al. "Touching the Phantom Limb." Nature, vol. 377, no. 6549, Oct. 1995, pp. 489-490, https://doi.org/10.1038/377489a0
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2384397-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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