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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03658915
Other study ID # AY32
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 28, 2018
Est. completion date January 23, 2019

Study information

Verified date February 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date January 23, 2019
Est. primary completion date January 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Faculty of Physical Therapy, Cairo University Dokki

Sponsors (1)

Lead Sponsor Collaborator
Aliaa Rehan Youssef

Country where clinical trial is conducted

Egypt, 

References & Publications (43)

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* Note: There are 43 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary concurrent validity of smartphone against isokinetic dynamometry in measuring joint position sense. 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 Intrarater reliability of smartphone measurements same investigator will repeat joint position sens assessment using smartphone application 1 week
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