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Completed

NCT Number: NCT05137028

Otago Exercise in Patient With Total Knee Replacement

To determine the effect of Otago exercise in Total Knee Replacement

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Key information

Conditions

Total Knee Replacement

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umer Bashir Hospital

Lalamusa, Punjab Province, 50200, Pakistan

About this study

Degenerative knee arthritis is one of the most common diseases in the elderly population. Age is the strongest risk factor for osteoarthritis. The 2010 Global Burden of Disease Study reports that the burden of musculoskeletal disorders is much larger than estimated in previous assessments and accounts for 6.8% of daily worldwide. An estimated 10% to 15% of all adults aged over 60 have some degree of OA. In Pakistan, 3.6% in rural and 3.1-4.6% in urban parts of Pakistan were found diagnosed by knee OA.

When conservative treatments fail to control the symptoms, joint replacement is performed. Specifically, more than 1 million surgeries are performed every year in the United States (US) alone, with a total expenditure close to 13.7 billion and 28.5 billion US dollars for the hips and knees, respectively. The demand is expected to increase by approximately 4 time by the year 2030 annually more than 4000 joint have been replaced in Pakistan." Overall, the progress of patients after joint replacement is satisfactory. Nevertheless, a substantial number may present with functional and balance limitations, even 1 year after surgery.

A cross sectional study reported that a Home-based balance and strength exercises (OEP) benefited older fallers with OA and gait and balance disorders by improving postural control. Another study has been done which suggested that elderly people who performed the OEP showed an increase in balance, muscle strength, and a decrease in both fall percentage and fall frequency. Evidence has recommended that, the OEP was more effective improving functional balance, muscle strength and physical health.

A cross sectional study was conducted to evaluate the influence of specific balance-targeted training on the overall state of balance in older adults undergoing TKR. They concluded that the additional balance training program improved balance performance to a higher extent than a control group.

After surgery, pain and stiffness are remarkably relieved, but functional and proprioceptive deficits, including limitation of lower limb mobility, difficulties in walking, and alterations instability and balance may remain. However, the effect of Otago exercise on balance are present in literature but the evidence for their influence in patients with TKR is narrow. So aim of this study to identify the possible role of Otago exercise program in particular population (TKR) and the prognosis in balance and Gait with this protocol in patients undergoing TKR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate
  • Participants who undergo unilateral cemented knee replacement due to arthritis

Exclusion criteria

  • Uncontrolled Hypertension
  • Lower extremity impairment that can limit the patient's function
  • Patient with neurological and cognitive impairment

Treatment and study plan

Otago Exercise

Other

Otago exercise protocol

Strengthening exercise:

Resistance exercise for knee flexors, knee extensors, hip abductor, ankle dorsiflexors, ankle planterflexors

Balance exercise:

knee bending, backward walking, walking and turning around, sideway walking, tendem stance, tendem walking, one leg stand, heel walking, toe walking, heel to toe walking, sit to stand, stair walking

Primary outcomes

  1. The Functional Reach test

    Time frame: 24 weeks

    The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. It ranges 6-10 inches greater than 10 inches indicate low risk of fall as lower than 6 inches has higher risk of fall.

  2. Timed Up and Go (TUG) Test

    Time frame: 24 weeks

    Measure of function with correlates to balance and fall risk. Less than 10 seconds for this task means normal while greater seconds mean higher risk of fall

  3. Single leg Stance (SLS) Test

    Time frame: 24 weeks

    The Single leg Stance (SLS) Test is used to assess static postural and balance control. Single leg stance more than 10 seconds is normal. Less than 5 seconds indicate higher risk of fall.

  4. Stair Climbing Test

    Time frame: 24 weeks

    Stair climbing test is used to assess Functional strength, balance and agility through ascending and descending a set number of steps. 5 minutes for 9 step of stairs means normal while more than 5 minutes for 9 step of stairs indicate risk of fall.

  5. Balance and Gait App

    Time frame: 24 weeks

    This app will use to assess the balance and gait. It has 4 competent 2 for static and 2 for dynamic. For static patient will stand for eyes open and close, and for dynamic patient will walk for 3 meter with and without head movement. Maximum time for each task is 30 seconds. For dynamic balance the average range for this age groups is 60-67 lower than this indicate higher risk of fall.

  6. Numerical Pain Rating Scale

    Time frame: 24 weeks

    Numeric Pain Rating Scale NPRS measure of the intensity of pain. Numerical pain rating scores is 0-10. 0 means no pain while 10 means worse pain.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Otago Exercise on Balance and Mobility in Patient With Total Knee Replacement

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2021
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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