The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis

NCT ID: NCT05287802

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aime to investigate the effects of balance and proprioception exercises using two different methods (classical balance training and Balance System™ SD) in addition to strengthening exercises on dynamic balance, pain, functional status and quality of life in patients with knee osteoarthritis (OA).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is known that knee OA leads to a decrease in proprioception and balance disturbances. Falls due to balance disorders often occur during dynamic activities such as walking and stair climbing. Therefore, correction of balance disorders is of great importance to prevent falls and associated fractures in the elderly population, in which knee OA is common. In addition, loss of proprioception in the knee joint, muscle weakness, and balance disorders are also known to contribute to the development of knee OA itself. Therefore, treatment of balance disorders may also slow the progression of the disease. This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This is a single-center randomized trial with 3 parallel arms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Balance; Distorted Proprioceptive Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This was a single-center randomized trial with 3 parallel arms
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The patients, the outcome assessor, care provider physicians, and the statistician were blinded to allocation. The supervising physician was not blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biodex Training (BT) group

Biodex Balance System features a platform that can move simultaneously in the anteroposterior (AP) or medio-lateral (ML) direction in 12 different levels of stability within a 20-degree range of inclination, as well as a locked position for static environments. For this platform, 1 represents the least stable level and 12 represents the most stable level. Interactive, game-like training modes are provided with the on-screen grid and score-keeping functions. Patients in the BT group performed exercises with the Balance SystemTM SD once a day, three days a week for 10 weeks under the physicians' supervision. Furthermore this group received closed kinetic chain exercises (CKCE) in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges.

Group Type ACTIVE_COMPARATOR

Balance and proprioception exercises

Intervention Type OTHER

Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises

Classical balance training group (CT group)

Patients in the CT group completed the exercise program once a day and three days a week during the 10-week period under the physicians' supervision. The exercises consisted of standing on one leg, tandem walking (heel-to-toe), balance board exercises, Romberg exercise, backward walking, and side-to-side stepping exercises. The total duration of these exercises was 20-30 minutes. Furthermore this group also received CKCE in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges.

Group Type ACTIVE_COMPARATOR

Balance and proprioception exercises

Intervention Type OTHER

Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises

Control group

Isometric home exercises, which can be considered the most basic and feasible strengthening program, were selected to compare the effects they had when added to the intervention groups and administered alone. All patients in the study performed isometric exercises for the quadriceps and hamstrings at home once a day, three days a week for 10 weeks. The exercises were performed as 10 repetitive cycles of six-second contractions and two-second rest periods. All patients were given a daily exercise chart to mark the home program, and adherence to the exercises was monitored weekly by telephone call.

Group Type ACTIVE_COMPARATOR

Home exercises program

Intervention Type OTHER

Isometric exercises for the quadriceps and hamstrings at home

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Balance and proprioception exercises

Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises

Intervention Type OTHER

Home exercises program

Isometric exercises for the quadriceps and hamstrings at home

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients were included if they had a knee OA diagnosis according to the American College of Rheumatology (ACR) diagnostic criteria, had suffered from knee pain for at least six months, had radiologically verified bilateral knee OA of grade II or III according to the Kellgren-Lawrence classification and had not previously participated in a regular exercise program.

Exclusion Criteria

* Patients who had undergone knee surgery, who had received hyaluronic acid or corticosteroid injections into the knee within six months, and patients with conditions that might affect balance were excluded from the study.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bozyaka Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

BUGRA INCE, MD

Role: PRINCIPAL_INVESTIGATOR

Bozyaka Training and Research Hospital

ALTINAY GOKSEL KARATEPE, MD

Role: STUDY_DIRECTOR

University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Izmir Bozyaka Research and Training Hostpital

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.

Reference Type BACKGROUND
PMID: 17216685 (View on PubMed)

Anwer S, Alghadir A, Brismee JM. Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2016 Jan-Mar;39(1):38-48. doi: 10.1519/JPT.0000000000000045.

Reference Type BACKGROUND
PMID: 25695471 (View on PubMed)

Niino N, Tsuzuku S, Ando F, Shimokata H. Frequencies and circumstances of falls in the National Institute for Longevity Sciences, Longitudinal Study of Aging (NILS-LSA). J Epidemiol. 2000 Apr;10(1 Suppl):S90-4. doi: 10.2188/jea.10.1sup_90.

Reference Type BACKGROUND
PMID: 10835834 (View on PubMed)

Khan SJ, Khan SS, Usman J, Mokhtar AH, Abu Osman NA. Effects of different foot progression angles and platform settings on postural stability and fall risk in healthy and medial knee osteoarthritic adults. Proc Inst Mech Eng H. 2018 Feb;232(2):163-171. doi: 10.1177/0954411917750409. Epub 2017 Dec 28.

Reference Type BACKGROUND
PMID: 29283019 (View on PubMed)

Jan MH, Lin CH, Lin YF, Lin JJ, Lin DH. Effects of weight-bearing versus nonweight-bearing exercise on function, walking speed, and position sense in participants with knee osteoarthritis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jun;90(6):897-904. doi: 10.1016/j.apmr.2008.11.018.

Reference Type BACKGROUND
PMID: 19480863 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BI1422

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.