NCT06160297

Brief Summary

. This study was carried out to examine the effects on walking, physical function and quality of life. There were 88 individuals in the study and they were divided into three groups as Modified Otago, Neuromuscular and Control groups. Traditional physiotherapy applications (Hotpack + Ultrasound (US) + Transcutaneous Electrical Nerve Stimulation (TENS) were applied to all groups. In addition to these applications, Modified Otago and Neuromuscular exercises were performed 2 days a week in a clinical setting, accompanied by a physiotherapist for 12 weeks. The control group was only followed up. Patients were evaluated for basic parameters before and after treatment: Berg Balance Scale (BBS) and Timed Up Go Test (TUG) for balance and fall risk, International Fall Efficiency Scale (FES-I) for fear of falling, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for symptoms and function, Tampa Kinesiophobia Scale (TKS) for kinesiophobia, 6-minute walk test for functional capacity (6MWT), Nottingham Health Profile (NHP) for quality of life, McGill Short Form (MSF) questionnaire for pain, an android-based smartphone application called "Gait Analyzer" were used for spatio-temporal variables in gait. Joint position sense (JPS) was measured with a goniometer and knee flexion was determined as 30° and 60° target angles. The exercise experiences of the groups who exercised after the treatment were evaluated by asking three questions with answers ranging from 0 to 10. It was observed that modified Otago and Neuromuscular exercises reduced the risk of falling and fear of falling, increased balance, decreased clinical symptoms and pain, increased function and quality of life, provided positive changes in the spatio-temporal parameters of walking and partially improved the sense of joint position compared to the control group (p\<0,05). When the exercise groups were compared, the Modified Otago group had more positive quality of life and pain than the Neuromuscular exercise group (p\<0.05). In addition, individuals in this group evaluated the exercises as less boring and less tiring (p\<0.001). Modified Otago and Neuromuscular exercises can be included in the treatment programs of individuals with geriatric knee osteoarthritis as exercises aimed at reducing possible falls. It was concluded that Modified Otago exercises are superior and therefore more preferable in terms of compliance and satisfaction of individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2021

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

Study Start

First participant enrolled

June 18, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

November 29, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

knee osteoarthritisfall riskmodified Otago exercisesneuromuscular exercisesgait kinematics

Outcome Measures

Primary Outcomes (6)

  • Functional Status Assessment

    WOMAC is a self-reported health status measure developed to assess pain, joint stiffness, and function that is widely used in patients with hip and knee osteoarthritis.

    3 months

  • Fall Risk Assessment

    Berg Balance Scale (BBS): BBS is used to evaluate an adult's balance abilities while performing functional tasks. Some functional activities such as standing up from a sitting position, standing without support, standing on one leg, various turning activities, standing with eyes closed, and chair transfers are evaluated. The scale consists of 14 items in Likert format and performances are scored as five different points (0-4), ranging from 0 "cannot do" to 4 "does independently and safely". The total score is between 0 and 56 points. The closer this value is to 0, the higher the risk of falling.

    3 months

  • Balance Assessment

    Timed Up and Go Test (TUG) :Recommended by the American Geriatrics Society and the British Geriatrics Society to screen for fall risk. This test was used to determine functional mobility and fall risk. For the test, patients were asked to sit on a chair. A target point was determined 3 meters away from the chair.

    3 months

  • Assessment of Fear of Falling

    Falls Efficacy Scale - International FES-I :International Falls Efficacy Scale is a 16-question self-reported scale that aims to obtain information about individuals' anxiety levels regarding falls while performing daily life activities. The questions are in Likert format and are scored as 4 points (1-4), from 1 "I am not worried at all" to 4 "I am very worried". The total score varies between 16-64 points, and the closer this score is to 64, the higher the fear of falling.

    3 months

  • Spatio-Temporal Variables of Gait

    For gait, a smartphone-based application called "Gait Analyzer" for gait (version 0.9.95.0 (Control One LLC, NM, USA)), offered as a paid application by the Android platform, whose reliability and validity have been tested-retested, was used. As a result of the measurement made with this application, kinematic data of walking such as walking speed, cadence, step time, step length, step length symmetry and step time symmetry can be obtained. After the program was installed on the smartphone (Huawei Mate 10 Lite, RNE-L01), some demographic data of the patient was entered. Afterwards, the smartphone was fixed to the area corresponding to the patient's L3 proccesus spinosus with a suitable waist belt with a velcro bandage. The measurement was then performed by asking the patients to walk a distance of 20 meters in their natural walking style and speed, without walking aid. The results were recorded on the form.

    3 months

  • Evaluation Quality of Life

    The Turkish version of the Nottingham Health Profile (NHP) was used to evaluate individuals' perceptions of quality of life. NHP is a quality of life scale used to measure individuals' perceived health status. It has been found to be extremely safe for use in OA populations. Turkish adaptation and psychometric properties study of the questionnaire was conducted by Küçükdeveci et al. It was conducted by in individuals with OA. The survey essentially consists of two parts. The first part deals with 6 health-related dimensions (pain-8, physical activity-8, energy level-3, sleep-5, social isolation-5 and emotional reactions-9) and consists of a total of 38 items. The second part consists of 7 items. Individuals are asked to evaluate the situations as "yes" or "no". Each section is scored between 0-100 points and the total score is scored between 0-600 points, thus obtaining a health profile score. Low scores indicate a good health profile, high scores indicate a poor health profile.

    3 months

Secondary Outcomes (5)

  • Pain Assessment

    3 months

  • Functional Capacity Evaluation

    3 months

  • Assessing Exercise Satisfaction

    3 months

  • Assessment of Kinesiophobia

    3 months

  • Joint Position Sense

    3 months

Study Arms (3)

Modified Otago Exercise Group

EXPERIMENTAL

MOEG consists of strengthening and balance exercises. Participants were instructed to start the exercises with 5-minute flexibility exercises. The walking component of the original Otago exercises and the stair climbing exercise in the balance exercises were not included in the MOEG. The exercises included 5 strengthening exercises and 11 balance exercises.

Procedure: Modified Otago Exercise

Neuromuscular Exercise Group

EXPERIMENTAL

Neuromuscular exercises basically consist of four exercise components. These; core stability / postural function, postural orientation, lower extremity muscle strength and functional exercises. Exercises also include 5-minute warm-up and cool-down periods.

Procedure: Neuromuscular Exercise

Control Group

NO INTERVENTION

Traditional physiotherapy applications (Hotpack + US (Ultrasound) + TENS (Transcutaneous Electrical Stimulation) were applied to the control group initially, as in every group. After these applications, they were evaluated in terms of basic parameters. A re-evaluation was made after 12 weeks.

Interventions

The exercises are as follows; Warm-up exercises (5 min) Strengthening exercises (weight attached to ankle) * Knee extension while sitting on a chair * Knee flexion while standing with support from a chair * Hip abduction while standing with support from the chair Strengthening exercises (weight removed from ankle) * Standing on tiptoe with support from a chair * Rising on the heels with support from a standing chair Balance Exercises (progressively, with support - without support) * Mini squats * Toe walking * Walking on heels * Tandem stance * Tandem walking * Walking backwards (10 steps) * Standing on one leg * Assisted side walking * Side walking without support * Sit and stand on the chair * Figure eight walking

Modified Otago Exercise Group

* Proprioceptive stabilization of the knee with ball * Bridging with ball * Stepping forward, sideways and backwards by holding on to a fixed support while standing * Doing the same movements with the support leg on a different surface * Hip abduction-adduction with resistance band * Knee flexion-extension with resistance band * Climbing and descending steps by taking steps * Balancing on the step * Standing up from the chair

Neuromuscular Exercise Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosed with knee OA
  • years and above - 80 years and below
  • BMI \<30 kg/m2
  • \< VAS score \< 8
  • Berg Balance Scale scores between 21-40
  • Have a score of 24 or above on the Standardized Mini Mental State Test
  • Not having received physiotherapy treatment in the last year.
  • Able to adapt to the training program,
  • Those who want to participate in volunteer work,
  • Individuals with informed consent

You may not qualify if:

  • Patients with positive Romberg Test
  • Patients with absolute angular error value more than 20˚ in the evaluation of joint position sense
  • Patients with B12 deficiency
  • Patients using antidepressant, anxiolytic and myorelaxant derivative drugs
  • Patients diagnosed with diabetes
  • Patients with discopathy
  • Those who have had lower extremity surgery, traumatic injury within the last six months, or are currently involved in a rehabilitation program
  • Refusing to participate in the study
  • Patients who cannot adapt to the training program.

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

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
PhD

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

June 18, 2021

Primary Completion

May 30, 2022

Study Completion

September 30, 2022

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations