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

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ClinicalTrials.gov Identifier: NCT03658915
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Aliaa Rehan Youssef, Cairo University

Study Description
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Brief Summary:
This study will investigate the concurrent validity and intra-rater reliability of using smartphone in assessing joint position sense in patient with knee osteoarthritis.

Condition or disease Intervention/treatment
Knee Osteoarthritis Device: Smartphone application (Goniometer Pro )

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 Design
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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Intrarater reliability of smartphone measurements [ Time Frame: 1 week ]
    same investigator will repeat joint position sens assessment using smartphone application


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects between 40 to 60 years old with symptomatic knee osteoarthritis and age-matched healthy control.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658915


Locations
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Egypt
Faculty of Physical Therapy, Cairo University
Dokki, Egypt
Sponsors and Collaborators
Aliaa Rehan Youssef
Investigators
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Principal Investigator: Aliaa Rehan Youssef, PhD Cairo University, Faculty of Physical Therapy
More Information
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Publications of Results:

Other Publications:
Oxford dictionary, accessed on April 19, 2018, https://en.oxforddictionaries.com/definition/smartphone).
Paillard, J., & Brouchon, M. (1968). Active and passive movements in the calibration of position sense. The neuropsychology of spatially oriented behavior. In: S.J. Freedman (ed), The neuropsychology of spatially oriented behavior, Dorsey Press, Homewood III., chap. 3, 37-55.

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Responsible Party: Aliaa Rehan Youssef, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03658915    
Other Study ID Numbers: AY32
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aliaa Rehan Youssef, Cairo University:
Position sense
Smartphone
Validity
Reliability
Knee osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases