NCT03893981

Brief Summary

The aim of the study is to investigate and compare the effect of balance and proprioception exercises with strengthening exercises on muscle strength, pain, proprioception, function and quality of life in knee osteoarthritis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 7, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

March 7, 2019

Last Update Submit

August 11, 2020

Conditions

Keywords

RehabilitationPainFunctionalityProprioception

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    The WOMAC is widely used self-administered health status measure used in assessing pain, stiffness and function in patients with OA of the knee or hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    WOMAC will be filled first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program . After treatment "change" will be assessed

Secondary Outcomes (10)

  • Visual Analogue Scale (VAS)

    Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

  • Pressure Algometer

    Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

  • Hand-Held Dynamometer

    Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

  • Isokinetic Dynamometer for measuring position sense

    Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

  • Short Form-36

    Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

  • +5 more secondary outcomes

Study Arms (2)

Proprioception and Balance Training

EXPERIMENTAL

Proprioception and Balance Program

Other: Proprioception and Balance Program

Strengthening Training

EXPERIMENTAL

Strengthening Program

Other: Strengthening Program

Interventions

Balance Trainer device and playing ball in tandem position for using to improve balance, vibration and reposition exercises for using to improve proprioception. Progressive of training will increase after each 2 weeks.Patients will be taken to the treatment program 3 days in a week for 8 weeks.

Proprioception and Balance Training

Exercises which include open and closed kinetic chain exercise will be applied to strength knee and hip muscle. Progressive of training will increase after each 2 weeks. Patients will be taken to the treatment program 3 days in a week for 8 weeks.

Strengthening Training

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have a diagnosis of knee Osteoarthritis according to the American Society of Rheumatology (ACR) criteria,
  • Between 45 to 75 years of age
  • Can read and write in Turkish language

You may not qualify if:

  • Active synovitis
  • Taking any physical therapy section in the last 6 months
  • Have a neurological problems that affect walking
  • Have an arthritis problem in the ankle and hip joint
  • Have a history of lower extremity surgery
  • Intraarticular steroid injection in the last 6 months
  • Use psychoactive drug
  • Have a severe defect of vision and hearing, speech disorders
  • Vestibular dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa, Faculty Of Health Sciences

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

ProprioceptionResistance Training

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological Phenomena

Study Officials

  • Gamze Kuş, MsC

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 28, 2019

Study Start

July 16, 2019

Primary Completion

August 11, 2020

Study Completion

August 11, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations