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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05137028
Other study ID # REC/01042 Allena Javed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 13, 2021
Est. completion date May 11, 2022

Study information

Verified date January 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effect of Otago exercise in Total Knee Replacement


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Otago Exercise
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

Locations

Country Name City State
Pakistan Umer Bashir Hospital Lalamusa Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Functional Reach test 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. 24 weeks
Primary Timed Up and Go (TUG) Test 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 24 weeks
Primary Single leg Stance (SLS) Test 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. 24 weeks
Primary Stair Climbing Test 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. 24 weeks
Primary Balance and Gait App 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. 24 weeks
Primary Numerical Pain Rating Scale 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. 24 weeks
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