NCT07848126

Brief Summary

The aim of this study is to investigate the effects of foam rolling in patients who have undergone total knee arthroplasty on pain, knee mobility, leg muscle strength, the ability to sense joint position, fear of movement, walking, balance, and the ability to perform daily activities. A total of 26 patients, with 13 patients in each group, will be included in the study. Participants will be randomly assigned to two groups. One group will receive the routine rehabilitation program, while the other group will receive foam rolling in addition to the routine rehabilitation program. Foam rolling and rehabilitation exercises will be taught at the Dokuz Eylül University Orthopedics and Traumatology Outpatient Clinic, and you will be asked to perform these exercises at home. The foam rolling group will perform foam rolling 6 days per week, 2 sets per day, with 3 repetitions of 60 seconds each. The control group will not perform foam rolling and will follow the routine rehabilitation program. The standard rehabilitation program will consist of strengthening exercises in different directions for the entire leg, range-of-motion exercises, stretching exercises, and walking exercises. You will be asked to perform the exercises for 3 sets of 10 repetitions per day. The assessments in the study will be performed at the second postoperative week (test 1), sixth postoperative week (test 2), and fourteenth postoperative week (test 3). These time points are also times when you would normally visit your doctor for routine follow-up; therefore, you will not be expected to make any additional hospital visits for the study. The study will continue for 1 year, and each patient will be followed for 14 weeks. Pain will be assessed using a single-question questionnaire. Walking, functional level, and leg muscle strength will be assessed using short performance tests involving sitting-to-standing and walking activities, as well as a questionnaire. Knee joint range of motion and proprioception will be assessed by measuring the angles of your knee using a ruler-like plastic device. Fear of movement will be assessed using a short questionnaire. All assessments will take no more than 20 minutes. The results will be determined by examining whether there are differences in these measurements between the different assessment time points.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Dec 2027

Study Start

First participant enrolled

September 9, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 18, 2026

Last Update Submit

September 29, 2026

Conditions

Keywords

total knee arthroplastyfoam rollerrondomized controlled trials

Outcome Measures

Primary Outcomes (2)

  • Change from baseline at week 14 in knee pain

    Pain will be assessed using the 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (unbearable pain).

    From enrollment to the end of the 14-week period

  • Change from baseline at week 14 in knee range of motion

    Knee range of motion will be measured using a 30-cm transparent plastic manual goniometer.

    From enrollment to the end of the 14-week period

Secondary Outcomes (6)

  • Change from baseline at week 14 in muscle strength

    From enrollment to the end of the 14-week period

  • Change from baseline at week 14 in knee joint proprioception

    From enrollment to the end of the 14-week period

  • Change from baseline at week 14 in kinesiophobia

    From enrollment to the end of the 14-week period

  • Change from baseline at week 14 in Timed Up and Go Test performance

    From enrollment to the end of the 14-week period

  • Change from baseline at week 14 in Five Times Sit-to-Stand Test performance

    From enrollment to the end of the 14-week period

  • +1 more secondary outcomes

Study Arms (2)

Foam rolling group

EXPERIMENTAL

The foam rolling intervention group will perform foam rolling for 4 weeks starting from the second postoperative week, 3 days per week, 1 set per day, with 3 repetitions of 60 seconds each.

Other: Foam rolling after total knee arthroplasty

Control group

ACTIVE COMPARATOR

The control group will not perform foam rolling and will follow the standard home exercise program. The standard home exercise program will consist of lower-extremity range-of-motion exercises, isometric exercises, stretching exercises for the knee joint, and straight leg raise exercises in different directions. Participants will be instructed to perform the exercises for 3 sets of 10 repetitions per day.

Other: Standard home exercise program after total knee arthroplasty

Interventions

The control group will not perform foam rolling and will follow the standard home exercise program. The standard home exercise program will consist of lower-extremity range-of-motion exercises, isometric exercises, stretching exercises for the knee joint, and straight leg raise exercises in different directions. Participants will be instructed to perform the exercises for 3 sets of 10 repetitions per day.

Control group

The foam rolling intervention will be performed for 4 weeks starting from the second postoperative week, 3 days per week, 1 set per day, with 3 repetitions of 60 seconds each.

Foam rolling group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate in the study
  • Scheduled for primary total knee arthroplasty
  • Age 40 years or older

You may not qualify if:

  • Body mass index (BMI) \> 40 kg/m²
  • History of revision surgery in the knee region
  • Any other orthopedic or neurological condition that may cause walking or functional impairment
  • Presence of heart disease or uncontrolled hypertension
  • Presence of neuromuscular or neurodegenerative disease
  • Inability to understand the study protocol instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Yokochi M, Nakamura M, Iwata A, Kaneko R, Yamada N, Konrad A. The acute cross-education effect of foam rolling on the thigh muscles in patients after total knee arthroplasty. Front Rehabil Sci. 2024 Oct 25;5:1433231. doi: 10.3389/fresc.2024.1433231. eCollection 2024.

  • Yokochi M, Nakamura M, Iwata A, Kaneko R, Watanabe S, Konrad A, Yamada N. The acute effect of roller massager on knee joint range of motion and muscle pain in older adults with total knee arthroplasty. J Musculoskelet Neuronal Interact. 2023 Jun 1;23(2):223-227.

  • Konrad A, Nakamura M, Tilp M, Donti O, Behm DG. Foam Rolling Training Effects on Range of Motion: A Systematic Review and Meta-Analysis. Sports Med. 2022 Oct;52(10):2523-2535. doi: 10.1007/s40279-022-01699-8. Epub 2022 May 26.

  • Konrad A, Nakamura M, Paternoster FK, Tilp M, Behm DG. A comparison of a single bout of stretching or foam rolling on range of motion in healthy adults. Eur J Appl Physiol. 2022 Jul;122(7):1545-1557. doi: 10.1007/s00421-022-04927-1. Epub 2022 Mar 17.

  • Yokochi M, Nakamura M, Iwata A, Kaneko R, Watanabe S, Konrad A, Yamada N. A 1-Week Comprehensive Foam Rolling Intervention Program Can Improve Knee Pain but Not Muscle Function and Range of Motion in Patients with Total Knee Arthroplasty. Int J Environ Res Public Health. 2023 Feb 14;20(4):3351. doi: 10.3390/ijerph20043351.

Study Officials

  • Bayram Ünver, Prof. Dr.

    Dokuz Eylul University

    STUDY DIRECTOR
  • Vasfi Karatosun, Prof. Dr.

    Dokuz Eylul University

    STUDY CHAIR
  • Gonca Cura, Physiotherapist

    Dokuz Eylul University

    STUDY CHAIR

Central Study Contacts

Öykü Bulduk, Physiotherapist

CONTACT

Bayram Ünver, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two parallel groups: a foam rolling group and a control group. The foam rolling group will receive foam rolling in addition to the standard home exercise program, while the control group will receive the standard home exercise program alone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 29, 2026

Study Start

September 9, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study does not plan to make individual-level participant data available to other researchers.

Locations