NCT07575425

Brief Summary

This prospective single-blind randomized controlled study aims to investigate the effects of mobilized balance platform exercises on balance parameters, pain, functional status, fear of falling, and kinesiophobia in patients with knee osteoarthritis. A total of 36 patients diagnosed with knee osteoarthritis will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital. Participants will be randomly assigned to one of two groups. The control group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises. The intervention group will receive the same conventional treatment in addition to mobilized balance platform exercises using the Huber 360 system. Pain severity, functional status, balance parameters, fear of falling, and kinesiophobia will be evaluated before and after treatment by an assessor blinded to treatment allocation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Oct 2026

First Submitted

Initial submission to the registry

May 3, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 3, 2026

Last Update Submit

May 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Static and Dynamic Balance Parameters

    Balance performance will be assessed using the Huber 360 balance assessment system. Measurements will include static balance with eyes open and eyes closed, single-leg balance performance, and limits of stability.

    Before treatment and immediately after completion of the 8-week treatment program

Secondary Outcomes (5)

  • Pain Severity Assessed by Visual Analog Scale (VAS)

    Before treatment and immediately after completion of the 8-week treatment program

  • Functional Status Assessed by WOMAC

    Before treatment and immediately after completion of the 8-week treatment program

  • Functional Mobility Assessed by Timed Up and Go Test

    Before treatment and immediately after completion of the 8-week treatment program

  • Fear of Falling Assessed by the International Falls Efficacy Scale

    Before treatment and immediately after completion of the 8-week treatment program

  • Kinesiophobia Assessed by Tampa Scale for Kinesiophobia

    Before treatment and immediately after completion of the 8-week treatment program

Study Arms (2)

Conventional Physical Therapy

ACTIVE COMPARATOR

Participants in this group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program. The home exercise program will include knee strengthening, balance, range of motion, proprioceptive, and stretching exercises, performed 3 days per week for 20 minutes.

Other: Conventional Physical Therapy

Mobilized Balance Platform Exercise

EXPERIMENTAL

Participants in this group will receive conventional physical therapy including TENS in addition to mobilized balance platform exercises using the Huber 360 system. The exercise protocol will include quadriceps and core strengthening, proprioceptive, balance, and neuromuscular exercises, performed 3 days per week for 20 minutes.

Device: Huber 360 Balance TrainingOther: Conventional Physical Therapy

Interventions

Participants will perform mobilized balance platform exercises using the Huber 360 system. The exercise protocol will include quadriceps and core strengthening, proprioceptive training, balance exercises, and neuromuscular exercises specifically designed for patients with knee osteoarthritis. Sessions will be performed 3 times per week for 20 minutes.

Mobilized Balance Platform Exercise

Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.

Conventional Physical TherapyMobilized Balance Platform Exercise

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 45 and 65 years
  • Diagnosis of knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
  • Willingness to participate voluntarily in the study

You may not qualify if:

  • Presence of orthopedic knee implants
  • Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis
  • Sensory impairment
  • Diagnosis of malignancy
  • Unhealed fractures
  • Circulatory disorders
  • Infection around the knee joint
  • Severe hearing loss or visual impairment
  • Cognitive impairment
  • Uncontrolled hypertension or diabetes mellitus
  • Vestibular disorders causing balance problems, such as vertigo
  • Use of walking assistive devices such as canes or walkers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler physical therapy and rehabilitation

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sefa Gümrük Aslan

    gaziler physcial therapy and rehabilitation hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEFA GÜMRÜK ASLAN

CONTACT

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
Assistant professor

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 8, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations