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
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2026
CompletedFirst Submitted
Initial submission to the registry
September 20, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
September 25, 2026
September 1, 2026
2 months
September 20, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Modified Sit-to-Stand (mSTS) Time
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 Outcomes (3)
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Baseline and immediately after the single-session intervention
Change in Knee Flexion Active Range of Motion (AROM)
Baseline and immediately after the single-session intervention
Change in 4-Meter Walk Test (4MWT) Time
Baseline and immediately after the single-session intervention
Other Outcomes (1)
Tampa Scale for Kinesiophobia-11 (TSK-11) Score
Baseline
Study Arms (2)
Unstable-Surface Group
EXPERIMENTALParticipants 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.
Stable-Surface Group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Choiseon Orthopedic Clinic
Naju, Jeollanamdo, South Korea
Related Publications (5)
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.
PMID: 33280460BACKGROUNDPua 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.
PMID: 35706119BACKGROUNDChristiansen 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.
PMID: 21839986BACKGROUNDMoutzouri 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.
PMID: 31101039BACKGROUNDMoutzouri 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.
PMID: 29473481BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master's student
Study Record Dates
First Submitted
September 20, 2026
First Posted
September 25, 2026
Study Start
September 7, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share