Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis

February 3, 2019 updated by: Aliaa Rehan Youssef
This study will investigate the concurrent validity and intra-rater reliability of using smartphone in assessing joint position sense in patient with knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Knee osteoarthritis is the most common arthritis. Such disease is complicated by many musculoskeletal dysfunction such as disturbed joint position sense, which impairs their ability to perform their regular daily activities. As rehabilitation should target impairment in function, it is essential that therapists assess joint sense during baseline and follow-up evaluation of patients to decide on needed therapeutic interventions. Joint position sense can be assessed by various methods such as motion tracking systems and the isokinetic dynamometer, yet these equipment are expensive and are not readily available at regular clinical settings.

Smartphone has been introduced as an assessment tool in rehabilitation of musculoskeletal disorders. For the knee joint, smartphone has been validated for measuring range of motion and joint position sense in healthy population, yet it has never been validated in patients with knee osteoarthritis. Therefore, this study will investigate smartphone validity and reliability as an assessment tool of knee position sense in patients with knee osteoarthritis.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Dokki, Egypt
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects between 40 to 60 years old with symptomatic knee osteoarthritis and age-matched healthy control.

Description

Inclusion Criteria:

  • Patient must be referred to the outpatient clinic of the faculty of Physical Therapy and Medicine, Cairo University with a confirmed diagnosis of unilateral or bilateral osteoarthritis of the knee and having one or more of the following criteria (ASo, 2000).
  • Morning stiffness for less than 30 minutes.
  • Crepitus on active knee movement.
  • Bony enlargement either palpable or visible in radiographs.
  • Bony tenderness at joint margins.
  • Age 40-60 years old.

Exclusion Criteria:

  • Steroid injection within 2 months prior to inclusion.
  • Presence of neurologic disorders (e.g., stroke, Parkinson's disease, or poliomyelitis). •Presence of other rheumatoid or orthopedic disorders in the lower extremity or spine. •A recent history of a lower extremity fracture with in the past year.
  • History of ligament deficiency, such as anterior cruciate ligament or meniscal injury.
  • Severe pain with active movement.
  • Poor memory or cognitive function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteoarthritis

Thirty symptomatic knee with osteoarthritis will be recruited according to the following criteria:

INCLUSION CRITERIA:

  1. Referred with a confirmed diagnosis of unilateral or bilateral OA of the knee based on the following criteria.

    1.1. Morning stiffness < 30 minutes, 1.2. Crepitus on active knee movement. 1.3. Bony enlargement either palpable or visible in radiographs. 1.4. Bony tenderness.

  2. Age 40-60 years old.

EXCLUSION CRITERIA:

  1. Steroid injection within the past 2 months.
  2. Presence of neurologic disorders.
  3. Presence of of orthopedic diseases or trauma in the lower extremity or spine within the past year.

6. Severe pain with active movement 7. Poor memory or cognitive function
Device: Smartphone application (Goniometer Pro )
Knee repositioning error will be measured simultaneously by smartphone and Biodex isokinetic dynamometer by a single blind assessor. All assessments will be done with eyes closed and repeated over two separate sessions, with one-week interval in-between. For active repositioning, the participant will actively extend the knee to reach a predetermined target position45° flexion at an angular velocity of 10°/sec. For passive knee repositioning, the isokinetic dynamometer will move the knee at 5°/s to a predetermined angle between 5° and 80° of flexion and the participant should stop the movement when the predetermined angle is reached.
Control
Thirty asymptomatic knee will be recruited for this study. Control group participants will be age-matched to the osteoarthritis group, and should have no pain or other relevant clinical symptoms in lower quadrant.
Device: Smartphone application (Goniometer Pro )
Knee repositioning error will be measured simultaneously by smartphone and Biodex isokinetic dynamometer by a single blind assessor. All assessments will be done with eyes closed and repeated over two separate sessions, with one-week interval in-between. For active repositioning, the participant will actively extend the knee to reach a predetermined target position45° flexion at an angular velocity of 10°/sec. For passive knee repositioning, the isokinetic dynamometer will move the knee at 5°/s to a predetermined angle between 5° and 80° of flexion and the participant should stop the movement when the predetermined angle is reached.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concurrent validity of smartphone against isokinetic dynamometry in measuring joint position sense.
Time Frame: One day
The extent to which a measure by Goniometer Pro application related to an outcome which is joint position sense in isokinetic dynamometer
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrarater reliability of smartphone measurements
Time Frame: 1 week
same investigator will repeat joint position sens assessment using smartphone application
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aliaa Rehan Youssef

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Actual)

January 23, 2019

Study Completion (Actual)

January 23, 2019

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 3, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AY32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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