NCT05850793

Brief Summary

Osteoarthritis is the most common type of arthritis, which can affect all joints in the body and includes synovial inflammation, cartilage degeneration, osteophyte formation and bone remodeling in its pathophysiology. Many approaches are used in its treatment, and the effectiveness of exercise in conservative treatment has been proven. Many exercise methods such as strengthening, balance, aquatherapy are applied, but there is no definite consensus on exercise prescribing.Programs that focus on restoring balance and proprioception are called "sensorimotor or neuromuscular trainings". Previous studies have shown that neuromuscular exercises reduce pain, improve function, improve balance, and cause positive biomechanical changes in knee osteoarthritis and meniscus injuries. Progressive Motor Imagery (AMI) is an approach in rehabilitation where the focus is on progressive brain exercise. It is an education that approaches patients with pain, activity limitation and functional loss with a holistic view within the framework of the biopsychosocial model. The aim of this study; to examine the effects of two current treatment programs (AMI, SM training) on symptoms, functionality, balance and proprioception parameters in osteoarthritis rehabilitation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

March 18, 2023

Last Update Submit

June 10, 2023

Conditions

Keywords

rehabilitationmotor imagery trainingsensorimotor trainingbalancefunctional performance

Outcome Measures

Primary Outcomes (1)

  • Balance

    For balance and fall risk assessment, the Biodex Balance System (BBS) (Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York) will be used. Computer result will be used to see falling risk and stability postural problems as anteroposterior and mediolateral. In the evaluation, while the patient stands without shoes on the BBS platform, the patients are asked to place their feet on the marked place, hold the BBS monitor and focus. The patient is asked to keep the cursor on the screen in the smallest circle shown on the device screen for 20 seconds while applying surface movements that can move between 20 and 360 degrees that will disrupt postural stability at different levels (12 most stable, 1 most mobile). Based on previous studies, the static assessment will be assessed at level 12, and the dynamic assessment and risk of falling will be assessed at level 8.

    change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks

Secondary Outcomes (2)

  • Pain of joint

    change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

  • Proprioception

    change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

Other Outcomes (6)

  • Functional Evaluation

    change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

  • Range of Motion

    change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

  • Cognitive status

    only at baseline evaluation for inclusion criteria (MMSE ≥ 24 point)

  • +3 more other outcomes

Study Arms (3)

Sensorimotor Exercise Training

EXPERIMENTAL

Sensorimotor exercise content has been prepared based on previous sensorimotor, balance and proprioceptive studies in the literature. It is organized as a structured traditional exercise program + SM training content.

Behavioral: Sensorimotor ExerciseBehavioral: Conventional Exercise

Progressive Motor Imagery Training

EXPERIMENTAL

In order to sequentially activate the cortical motor networks and improve cortical organization, a literature-supported program including the components of AMI training (first stage laterality training, second stage motor imagery and third stage mirror therapy) was prepared and a six-week structured exercise program suitable for knee joint treatment + AMI training was prepared.

Behavioral: Conventional ExerciseBehavioral: Progressive Motor Imagery Exercise

Conventional Exercise Training

ACTIVE COMPARATOR

A 6-week program was prepared from traditional treatment exercises based on previous studies in knee osteoarthritis. It consists of progressive muscle strengthening of Quadriceps, Hamstrings and gluteals and also stretching exercises.

Behavioral: Sensorimotor ExerciseBehavioral: Conventional ExerciseBehavioral: Progressive Motor Imagery Exercise

Interventions

Balance, perturbation , aging and strengthing exercise will be performed for knee

Conventional Exercise TrainingSensorimotor Exercise Training

Range of motion, strengthing and stretching exercise will be performed for knee

Also known as: traditional exercise for osteoarthritis
Conventional Exercise TrainingProgressive Motor Imagery TrainingSensorimotor Exercise Training

Different types of exercises will be applied targeting muscle strength, proprioceptive sense or brain neurons for knee

Conventional Exercise TrainingProgressive Motor Imagery Training

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR),
  • Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria,
  • Between the ages of 50 and 65,
  • Body mass index below 35 kg/m²,
  • Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS,
  • There are no obstacles to being included in the exercise program,
  • Patients with a score of at least 24 on the Standardized Mini Mental Test will be included.

You may not qualify if:

  • Receiving any physiotherapy program or injection treatment in the last 3 months,
  • Having a diagnosis of additional pathology other than OA in the knee, having a history of knee injury / surgery in the past
  • Having uncontrollable hypertension, cardiovascular and neurological diseases that will prevent exercise,
  • The patient has any vision, hearing or cognitive problems that will prevent him from complying with the treatment,
  • Providing ambulation with an assistive device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Karadüz

Fatih, Istanbul, 34083, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • Busija L, Bridgett L, Williams SR, Osborne RH, Buchbinder R, March L, Fransen M. Osteoarthritis. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):757-68. doi: 10.1016/j.berh.2010.11.001.

    PMID: 21665124BACKGROUND
  • Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.

    PMID: 26405113BACKGROUND
  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PMID: 24553908BACKGROUND
  • Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.

    PMID: 33406330BACKGROUND
  • Zhang W, Doherty M, Peat G, Bierma-Zeinstra MA, Arden NK, Bresnihan B, Herrero-Beaumont G, Kirschner S, Leeb BF, Lohmander LS, Mazieres B, Pavelka K, Punzi L, So AK, Tuncer T, Watt I, Bijlsma JW. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Ann Rheum Dis. 2010 Mar;69(3):483-9. doi: 10.1136/ard.2009.113100. Epub 2009 Sep 17.

    PMID: 19762361BACKGROUND
  • Dominguez-Navarro F, Igual-Camacho C, Silvestre-Munoz A, Roig-Casasus S, Blasco JM. Effects of balance and proprioceptive training on total hip and knee replacement rehabilitation: A systematic review and meta-analysis. Gait Posture. 2018 May;62:68-74. doi: 10.1016/j.gaitpost.2018.03.003. Epub 2018 Mar 5.

    PMID: 29525292BACKGROUND
  • Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.

    PMID: 17082465BACKGROUND
  • Baird CL, Sands L. A pilot study of the effectiveness of guided imagery with progressive muscle relaxation to reduce chronic pain and mobility difficulties of osteoarthritis. Pain Manag Nurs. 2004 Sep;5(3):97-104. doi: 10.1016/j.pmn.2004.01.003.

    PMID: 15359221BACKGROUND
  • Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • EBRU KARADÜZ, PhD(c)

    İstanbul Medipol University

    PRINCIPAL INVESTIGATOR
  • Sena TOLU, Asist Prof

    Medipol Mega Hospital

    STUDY CHAIR
  • Candan Algun, Prof

    İstanbul Medipol University

    STUDY CHAIR

Central Study Contacts

EBRU KARADÜZ, MSc

CONTACT

Sena TOLU, Assist Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participants and the researcher who evaluated the analysis are blind to the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist (MSc ) / PhD (continous) / Lecturer Ebru Gülek Karadüz

Study Record Dates

First Submitted

March 18, 2023

First Posted

May 9, 2023

Study Start

May 15, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations