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Not yet recruitingNCT07840768Updated Sep 25, 2026

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

An interventional study of Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface and Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface in Total Knee Arthroplasty and Postoperative Rehabilitation, sponsored by Sahmyook University. Not yet recruiting at 1 site in South Korea. Open to participants aged 60 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Sahmyook University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
60 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Total Knee Arthroplasty
  • Postoperative Rehabilitation

Keywords

  • Total Knee Arthroplasty
  • Early Rehabilitation
  • Sit-to-Stand
  • Proprioceptive Stimulation
03

Who can participate

Ages eligible
60 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • 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.

    Other: Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface

  • 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.

    Other: Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface

Interventions

  • OtherLow-Intensity Plantar Proprioceptive Stimulation 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.

  • OtherLow-Intensity Plantar Proprioceptive Stimulation on a Stable 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.

05

What researchers measure

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.

    Time frame: Baseline and immediately after the single-session intervention

Secondary outcomes

  1. Change in Pain Intensity Measured by Visual Analog Scale (VAS)

    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.

    Time frame: Baseline and immediately after the single-session intervention

  2. Change in Knee Flexion Active Range of Motion (AROM)

    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.

    Time frame: Baseline and immediately after the single-session intervention

  3. Change in 4-Meter Walk Test (4MWT) Time

    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.

    Time frame: Baseline and immediately after the single-session intervention

Other outcomes

  1. Tampa Scale for Kinesiophobia-11 (TSK-11) Score

    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.

    Time frame: Baseline

06

Study locations

1 site
  • Choiseon Orthopedic Clinic
    Naju, Jeollanamdo, South Korea
07

References and documents

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. PubMed 33280460 ↗
  • 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. PubMed 35706119 ↗
  • 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. PubMed 21839986 ↗
  • 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. PubMed 31101039 ↗
  • 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. PubMed 29473481 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07840768
Lead sponsor
Sahmyook University
Responsible party
SEUNGWOO KIM (master's student, Sahmyook University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 7, 2026 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Sep 25, 2026

Study contacts

Suengwoo Kim
Contact
obsekim22@naver.com
+82 10-4128-3839

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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