Immediate Effects of Low-Intensity Plantar Proprioceptive Stimulation of the Affected Limb on Stable Versus Unstable Surfaces on Modified Sit-to-Stand Time and Gait Following Total Knee Arthroplasty
This randomized controlled study will investigate the immediate effects of low-intensity plantar proprioceptive stimulation performed on an unstable versus stable surface in patients during early rehabilitation after unilateral total knee arthroplasty (TKA).
Participants will be randomly assigned to either an unstable-surface group or a stable-surface group. While seated, participants will apply low-intensity pressure through the operated foot using a standardized repeated pressing task. The unstable-surface group will perform the task with the operated foot placed on a balance pad, whereas the stable-surface group will perform the same task on a firm surface.
The primary outcome will be the time required to perform a modified sit-to-stand task. Secondary outcomes will include walking performance, pain, and knee range of motion. The study aims to determine whether providing additional plantar proprioceptive input through an unstable surface can produce an immediate improvement in functional performance during early rehabilitation after TKA.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Suengwoo Kim
- Phone Number: +82 10-4128-3839
- Email: obsekim22@naver.com
Study Locations
-
-
Jeollanamdo
-
Naju, Jeollanamdo, South Korea
- Choiseon Orthopedic Clinic
-
Contact:
- Seungwoo Kim
- Phone Number: +82 10-4128-3839
- Email: obsekim22@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 60 to 79 years.
- Patients who underwent unilateral total knee arthroplasty (TKA) and are 7 to 14 days postoperatively at the time of study participation.
- Patients who have begun independent gait training using a walker.
- Able to understand the purpose of the study and provide written informed consent.
Exclusion Criteria:
- Bilateral total knee arthroplasty.
- Severe neurological disease or severe peripheral nervous system disorder.
- Orthostatic hypotension.
- Postoperative cognitive impairment that makes it difficult to understand instructions or perform the study tasks.
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 |
|---|---|
|
Experimental: Unstable-Surface Group
Participants will perform low-intensity plantar proprioceptive stimulation while seated, with the operated foot placed on a balance pad. The intervention consists of repeated low-intensity pressing through the operated foot on an unstable surface. |
Participants will perform low-intensity plantar proprioceptive stimulation while seated with the operated foot placed on a balance pad. They will apply low-intensity pressure through the operated foot for 5 seconds followed by 5 seconds of relaxation. The cycle will be repeated 12 times for approximately 2 minutes. |
|
Active Comparator: Stable-Surface Group
Participants will perform the same low-intensity plantar proprioceptive stimulation while seated, with the operated foot placed on a firm surface. The pressing procedure will be identical to that of the unstable-surface group except for the supporting surface. |
Participants will perform the same low-intensity plantar proprioceptive stimulation while seated with the operated foot placed on a firm surface. They will apply low-intensity pressure through the operated foot for 5 seconds followed by 5 seconds of relaxation. The cycle will be repeated 12 times for approximately 2 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Modified Sit-to-Stand (mSTS) Time
Time Frame: Baseline and immediately after the single-session intervention
|
Time required to complete one modified sit-to-stand (mSTS) task will be measured in seconds. The task will be video-recorded using a smartphone at 60 frames per second and analyzed using Kinovea software. Time will be calculated from seat-off to attainment of a fully upright standing position. Participants will be allowed to use upper-extremity support as needed. Measurements will be performed before and immediately after the intervention. A shorter time indicates better sit-to-stand performance. |
Baseline and immediately after the single-session intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Baseline and immediately after the single-session intervention
|
Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Participants will mark the point on the scale that best represents their current knee pain. The distance from the 0-mm anchor to the participant's mark will be measured in millimeters. Measurements will be performed before and immediately after the single-session intervention. A lower score indicates less pain. |
Baseline and immediately after the single-session intervention
|
|
Change in Knee Flexion Active Range of Motion (AROM)
Time Frame: Baseline and immediately after the single-session intervention
|
Active knee flexion range of motion (AROM) of the operated limb will be measured in degrees using a standard goniometer with the participant in the supine position. Participants will be instructed to actively flex the operated knee as far as comfortably possible. Measurements will be performed before and immediately after the single-session intervention. A greater flexion angle indicates greater active knee flexion range of motion. |
Baseline and immediately after the single-session intervention
|
|
Change in 4-Meter Walk Test (4MWT) Time
Time Frame: Baseline and immediately after the single-session intervention
|
Walking performance will be assessed using the 4-Meter Walk Test (4MWT). Participants will be instructed to walk 4 meters at their usual comfortable walking speed. The time required to complete the 4-meter distance will be recorded in seconds. Participants may use their usual walking aid if required for safety. Measurements will be performed before and immediately after the single-session intervention. A shorter completion time indicates better walking performance. |
Baseline and immediately after the single-session intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale for Kinesiophobia-11 (TSK-11) Score
Time Frame: Baseline
|
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia-11 (TSK-11), an 11-item self-reported questionnaire assessing fear of movement or reinjury. Each item is rated on a 4-point Likert scale. A higher total score indicates a greater level of kinesiophobia. The TSK-11 will be used as an exploratory psychological measure. |
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kittelson A, Carmichael J, Stevens-Lapsley J, Bade M. Psychometric properties of the 4-meter walk test after total knee arthroplasty. Disabil Rehabil. 2022 Jun;44(13):3204-3210. doi: 10.1080/09638288.2020.1852446. Epub 2020 Dec 5.
- Pua YH, Tan JW, Poon CL, Chew ES, Seah FJ, Thumboo J, Yeo SJ, Woon EL, Clark RA. Sit-to-Stand Weight-Bearing Symmetry Performance in Total Knee Arthroplasty: Recovery Curves, Correlates, and Predictive Validity With Gait Speed. Am J Phys Med Rehabil. 2022 Jul 1;101(7):666-673. doi: 10.1097/PHM.0000000000001882. Epub 2021 Oct 4.
- Christiansen CL, Bade MJ, Judd DL, Stevens-Lapsley JE. Weight-bearing asymmetry during sit-stand transitions related to impairment and functional mobility after total knee arthroplasty. Arch Phys Med Rehabil. 2011 Oct;92(10):1624-9. doi: 10.1016/j.apmr.2011.05.010. Epub 2011 Aug 12.
- Moutzouri M, Coutts F, Gliatis J, Billis E, Tsepis E, Gleeson N. Early initiation of home-based sensori-motor training improves muscle strength, activation and size in patients after knee replacement: a secondary analysis of a controlled clinical trial. BMC Musculoskelet Disord. 2019 May 17;20(1):231. doi: 10.1186/s12891-019-2575-3.
- Moutzouri M, Gleeson N, Coutts F, Tsepis E, Gliatis J. Early self-managed focal sensorimotor rehabilitative training enhances functional mobility and sensorimotor function in patients following total knee replacement: a controlled clinical trial. Clin Rehabil. 2018 Jul;32(7):888-898. doi: 10.1177/0269215518757291. Epub 2018 Feb 23.
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
Other Study ID Numbers
- 2026-05-052-002
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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