NCT07840768

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

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress51%
Sep 2026Oct 2026

Study Start

First participant enrolled

September 7, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 20, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Total Knee ArthroplastyEarly RehabilitationSit-to-StandProprioceptive Stimulation

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

EXPERIMENTAL

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

Stable-Surface Group

ACTIVE COMPARATOR

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

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.

Unstable-Surface Group

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.

Stable-Surface Group

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 33280460BACKGROUND
  • 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.

    PMID: 35706119BACKGROUND
  • 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.

    PMID: 21839986BACKGROUND
  • 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.

    PMID: 31101039BACKGROUND
  • 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.

    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

Locations