NCT06802107

Brief Summary

The aim of this study is to investigate and compare the effects of forward and backward walking exercises on treadmill in addition to traditional physiotherapy interventions on pain, physical performance and balance in patients with knee osteoarthritis. Secondarily, it is aimed to investigate the effects of walking on spatio-temporal parameters, knee joint position sense, range of motion, quadriceps, hamstring and hip adductors muscle strength, Q angle, quality of life and kinesiophobia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

January 15, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Keywords

knee osteoarthritisWalkingTreadmillBackwardForward

Outcome Measures

Primary Outcomes (8)

  • Pain

    It will be evaluated with the visual analog scale (VAS). VAS consists of a horizontal 10 cm long line, where "0" (zero) indicates no pain and "10" indicates unbearable pain. The patient is asked to indicate where their condition fits on this line by drawing a line, putting a dot or pointing.

    8 weeks

  • Physical Function and Performance Measures

    Western Ontario and McMaster Üniversiteleri Osteoartrit İndeksi (WOMAC) WOMAC is a self-reported health status measure developed to assess pain, joint stiffness, and function in patients with hip and knee osteoarthritis. It questions patients on three separate clinical dimensions: pain, joint stiffness, and function. It contains a total of 24 questions. The three subdimensions that make up the scale can be scored individually or as a total. Higher scores represent worse pain, physical function, and stiffness.

    8 weeks

  • Physical Function and Performance Measures

    30 second Chair test A test that evaluates the patient's sit-to-stay activity, lower extremity strength and dynamic balance. The number of times the patient sits down and stands up in 30 seconds gives the test score.

    8 weeks

  • Physical Function and Performance Measures

    40 meter fast paced walk test This test evaluates the speed and direction change activity of short-distance walking, especially in individuals with hip and knee osteoarthritis.

    8 weeks

  • Physical Function and Performance Measures

    Stair climb test A test that evaluates the patient's stair climbing and descending activity, lower extremity strength and dynamic balance. Ideally, the desired time to go up and down 9 steps gives the result of the test.

    8 weeks

  • Physical Function and Performance Measures

    6 minute walk test A test that evaluates functional capacity in individuals. The test is performed in a closed and uncrowded space. The distance between the starting and finishing points in a closed space should be 30 meters on a flat surface. The distance an individual can walk in this area in 6 minutes is evaluated in meters. Before the test begins, the patient is rested and information about the test is given to the patient. The patient is asked to walk between the starting and finishing points at their own walking pace. The test is monitored with a stopwatch. The purpose of the test is to measure the maximum distance they can walk during this time

    8 weeks

  • balance

    Timed up and go test This test measures the dynamic balance and functional mobility. It is a test that measures the time in seconds for the individual to stand up from a standard chair (seat height of approximately 44 cm, arm height 65 cm), walk a distance of 3 meters, turn around and sit on the chair.

    8 weeks

  • balance

    Functional Reach Test A test developed to examine forward stability. During the test, participants' ability to reach forward while standing with their feet fixed is recorded as a distance and their balance performance is evaluated.

    8 weeks

Secondary Outcomes (7)

  • knee joint position sense

    8 weeks

  • Knee Range of Motion Assessment

    8 weeks

  • Quadriceps, Hamstring and hip adduction strength

    8 weeks

  • Q açısı

    8 weeks

  • Kinesiophobia

    8 weeks

  • +2 more secondary outcomes

Study Arms (3)

Backward-treadmill Walking Group

EXPERIMENTAL

Individuals in this group will do backward treadmill walking in addition to traditional physiotherapy.

Behavioral: Backward-treadmill WalkingOther: Traditional physiotherapy

Forward-treadmill Walking Group

EXPERIMENTAL

Individuals in this group will do forward treadmill walking in addition to traditional physiotherapy. .

Behavioral: Forward-treadmill WalkingOther: Traditional physiotherapy

Control Group

ACTIVE COMPARATOR

This group will receive standard traditional physiotherapy. Traditional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications.

Other: Traditional physiotherapy

Interventions

A backward walking program will be applied on the treadmill. To be done 3 times a week / 8 weeks. Before the walking exercises, 5 minutes of warm-up and 5 minutes of cool-down exercises will be performed. While walking on the treadmill, the participant can hold onto the railings. Each participant will start at the speed they choose and gradually increase their perceived exertion rate to 11-13 on the Borg scale, and it is planned to walk for 10 minutes in the first week and gradually for 20-30 minutes in the following weeks.

Backward-treadmill Walking Group

A forward walking program will be applied on the treadmill. To be done 3 times a week / 8 weeks. Before the walking exercises, 5 minutes of warm-up and 5 minutes of cool-down exercises will be performed. While walking on the treadmill, the participant can hold onto the railings. Each participant will start at the speed they choose and gradually increase their perceived exertion rate to 11-13 on the Borg scale, and it is planned to walk for 10 minutes in the first week and gradually for 20-30 minutes in the following weeks.

Forward-treadmill Walking Group

Traditional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications. To be done 3 times a week / 8 weeks. 20 min hotpack + 7 min ultrasound + 20 min TENS and knee osteoarthritis exercises (hip knee flexion extension, knee extension while sitting on a chair, quadriceps isometric exercise in the supine position, straight leg raise exercises) are planned to be applied in the clinic with the physiotherapist. The exercises are planned to be started with 5 repetitions in the first week and the intensity of the exercise is planned to be increased with 10 repetitions, 15 repetitions and 20 repetitions depending on the patient's tolerance.

Backward-treadmill Walking GroupControl GroupForward-treadmill Walking Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with knee OA
  • According to the Kellgren Lawrence scale, grade I-II-III knee OA
  • VAS score above 3

You may not qualify if:

  • Knee pain caused by other diseases (rheumatoid arthritis, gouty arthritis, etc.)
  • History of lower extremity surgery
  • Receiving physical therapy within the last 6 months
  • A medical condition that prevents safe exercise
  • Intra-articular injection (hyaluronic acid/steroid) application within the last 6 months
  • Diabetic neuropathy
  • Active and regular exercise,
  • Not volunteering to participate in the study
  • Patients with osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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
phd student

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

January 15, 2025

Primary Completion

October 15, 2025

Study Completion

December 30, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations