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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-79
SponsorSahmyook University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Low-Intensity Plantar Proprioceptive Stimulation on an Unstable Surface

    Other intervention

    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 Surface

    Other intervention

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Unstable-Surface GroupExperimental treatment 1 intervention
Group B: Stable-Surface GroupActive comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: