NCT05137028

Brief Summary

To determine the effect of Otago exercise in Total Knee Replacement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

November 18, 2021

Last Update Submit

January 13, 2023

Conditions

Keywords

Balance trainingTotal knee replacementOtago exercise

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Otago Exercise

EXPERIMENTAL

Otago Exercise Group

Other: Otago Exercise

Interventions

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

Otago Exercise

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umer Bashir Hospital

Lalamusa, Punjab Province, 50200, Pakistan

Location

Study Officials

  • Aruba Saeed, PhD*

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2021

First Posted

November 30, 2021

Study Start

November 13, 2021

Primary Completion

May 11, 2022

Study Completion

May 11, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations