Total Knee ArthroplastyNCT07840768
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
A study testing Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface and Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface in people with Total Knee Arthroplasty and Postoperative Rehabilitation, run by Sahmyook University at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Rehabilitation
- What is being tested?
- Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface and Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Sep 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Choiseon Orthopedic Clinic
Naju, Jeollanamdo
Seungwoo Kim, +82 10-4128-3839, obsekim22@naver.com
About this study
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.
- Being tested
- Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface, Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface
- Keywords
- Total Knee Arthroplasty, Early Rehabilitation, Sit-to-Stand, Proprioceptive Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Plantar Proprioceptive Stimulation on an Unstable SurfaceOther
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.
Low-Intensity Plantar Proprioceptive Stimulation on a Stable SurfaceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the single-session intervention
Secondary outcomes (3)
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.
Measured: Baseline and immediately after the single-session intervention
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.
Measured: Baseline and immediately after the single-session intervention
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.
Measured: Baseline and immediately after the single-session intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start7 Sep 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEUNGWOO KIM, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840768
- Sponsor's protocol ID
- 2026-05-052-002
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33280460Pua 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 35706119Christiansen 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 21839986Moutzouri 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 31101039Moutzouri 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07840768
- Acronym / sponsor ID
- 2026-05-052-002
- Keywords
- Total Knee Arthroplasty, Early Rehabilitation, Sit-to-Stand, Proprioceptive Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable-Surface Group | Experimental | Other: Low-Intensity Plantar Proprioceptive Stimulation on an Unstable SurfaceParticipants 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 comparator | Other: Low-Intensity Plantar Proprioceptive Stimulation on a Stable SurfaceParticipants 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. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Plantar Proprioceptive Stimulation on an Unstable SurfaceParticipants 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. | Other | Unstable-Surface Group |
| Low-Intensity Plantar Proprioceptive Stimulation on a Stable SurfaceParticipants 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. | Other | Stable-Surface Group |
Primary outcome
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.
3 secondary outcomes
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 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
Change in 4-Meter Walk Test (4MWT) Time
Time frame: Baseline and immediately after the single-session intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 33280460Kittelson 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.
- Background: PubMed 35706119Pua 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.
- Background: PubMed 21839986Christiansen 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.
- Background: PubMed 31101039Moutzouri 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.
- Background: PubMed 29473481Moutzouri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface and Low-Intensity Plantar Proprioceptive Stimulation on a Stable Surface in people with Total Knee Arthroplasty and Postoperative Rehabilitation, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suengwoo Kim (+82 10-4128-3839, obsekim22@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Sit-to-Stand (mSTS) Time (time frame: Baseline and immediately after the single-session intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07840768, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.