Knee OsteoarthritisNCT03658915
Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Aliaa Rehan Youssef at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Smartphone application (Goniometer Pro )
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2018to 23 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects between 40 to 60 years old with symptomatic knee osteoarthritis and age-matched healthy control.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the concurrent validity and intra-rater reliability of using smartphone in assessing joint position sense in patient with knee osteoarthritis.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Smartphone application (Goniometer Pro )
- Keywords
- Position sense, Smartphone, Validity, Reliability, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application (Goniometer Pro )Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Smartphone application (Goniometer Pro ) | |
| 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. Receives: Device: Smartphone application (Goniometer Pro ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day
Secondary outcomes (1)
Intrarater reliability of smartphone measurements
same investigator will repeat joint position sens assessment using smartphone application
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start28 Nov 2018
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aliaa Rehan Youssef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aliaa Rehan Youssef, Cairo University
- Investigators
- Aliaa Rehan Youssef, PhD, Principal investigator, Cairo University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658915
- Sponsor's protocol ID
- AY32
- Status last verified
- Feb 2019
- First submitted
- 3 Sep 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data for all primary and secondary outcome measures will be made available.
Publications
Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
PubMed 11014340Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
PubMed 14508689Galan-Mercant A, Baron-Lopez FJ, Labajos-Manzanares MT, Cuesta-Vargas AI. Reliability and criterion-related validity with a smartphone used in timed-up-and-go test. Biomed Eng Online. 2014 Dec 2;13:156. doi: 10.1186/1475-925X-13-156.
PubMed 25440533Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.
PubMed 20522675Grob KR, Kuster MS, Higgins SA, Lloyd DG, Yata H. Lack of correlation between different measurements of proprioception in the knee. J Bone Joint Surg Br. 2002 May;84(4):614-8. doi: 10.1302/0301-620x.84b4.11241.
PubMed 12043789Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3.
PubMed 30356896Ho-Pham LT, Lai TQ, Mai LD, Doan MC, Pham HN, Nguyen TV. Prevalence of radiographic osteoarthritis of the knee and its relationship to self-reported pain. PLoS One. 2014 Apr 10;9(4):e94563. doi: 10.1371/journal.pone.0094563. eCollection 2014.
PubMed 24722559Hurkmans EJ, van der Esch M, Ostelo RW, Knol D, Dekker J, Steultjens MP. Reproducibility of the measurement of knee joint proprioception in patients with osteoarthritis of the knee. Arthritis Rheum. 2007 Dec 15;57(8):1398-403. doi: 10.1002/art.23082.
PubMed 18050179Jenny JY, Bureggah A, Diesinger Y. Measurement of the knee flexion angle with smartphone applications: Which technology is better? Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2874-2877. doi: 10.1007/s00167-015-3537-4. Epub 2015 Feb 15.
PubMed 25682165Kaminski TW, Hartsell HD. Factors Contributing to Chronic Ankle Instability: A Strength Perspective. J Athl Train. 2002 Dec;37(4):394-405.
PubMed 12937561Kimberlin CL, Winterstein AG. Validity and reliability of measurement instruments used in research. Am J Health Syst Pharm. 2008 Dec 1;65(23):2276-84. doi: 10.2146/ajhp070364.
PubMed 19020196Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.
PubMed 21251988Kramer J, Handfield T, Kiefer G, Forwell L, Birmingham T. Comparisons of weight-bearing and non-weight-bearing tests of knee proprioception performed by patients with patello-femoral pain syndrome and asymptomatic individuals. Clin J Sport Med. 1997 Apr;7(2):113-8. doi: 10.1097/00042752-199704000-00007.
PubMed 9113427Kujala UM, Kettunen J, Paananen H, Aalto T, Battie MC, Impivaara O, Videman T, Sarna S. Knee osteoarthritis in former runners, soccer players, weight lifters, and shooters. Arthritis Rheum. 1995 Apr;38(4):539-46. doi: 10.1002/art.1780380413.
PubMed 7718008Lee D, Han S. Validation of Joint Position Sense of Dorsi-Plantar Flexion of Ankle Measurements Using a Smartphone. Healthc Inform Res. 2017 Jul;23(3):183-188. doi: 10.4258/hir.2017.23.3.183. Epub 2017 Jul 31.
PubMed 28875053
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03658915
- Acronym / sponsor ID
- AY32
- Conditions
- Knee Osteoarthritis
- Keywords
- Position sense, Smartphone, Validity, Reliability, Knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aliaa Rehan YoussefUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the concurrent validity and intra-rater reliability of using smartphone in assessing joint position sense in patient with knee osteoarthritis.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis | – | Device: Smartphone application (Goniometer Pro )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 |
| Control | – | Device: Smartphone application (Goniometer Pro )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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects between 40 to 60 years old with symptomatic knee osteoarthritis and age-matched healthy control.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Control, Osteoarthritis |
Primary outcome
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
1 secondary outcome
Intrarater reliability of smartphone measurements
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 11014340Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
- Background: PubMed 14508689Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
- Background: PubMed 25440533Galan-Mercant A, Baron-Lopez FJ, Labajos-Manzanares MT, Cuesta-Vargas AI. Reliability and criterion-related validity with a smartphone used in timed-up-and-go test. Biomed Eng Online. 2014 Dec 2;13:156. doi: 10.1186/1475-925X-13-156.
- Background: PubMed 20522675Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.
- Background: PubMed 12043789Grob KR, Kuster MS, Higgins SA, Lloyd DG, Yata H. Lack of correlation between different measurements of proprioception in the knee. J Bone Joint Surg Br. 2002 May;84(4):614-8. doi: 10.1302/0301-620x.84b4.11241.
- Background: PubMed 30356896Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3.
- Background: PubMed 24722559Ho-Pham LT, Lai TQ, Mai LD, Doan MC, Pham HN, Nguyen TV. Prevalence of radiographic osteoarthritis of the knee and its relationship to self-reported pain. PLoS One. 2014 Apr 10;9(4):e94563. doi: 10.1371/journal.pone.0094563. eCollection 2014.
- Background: PubMed 18050179Hurkmans EJ, van der Esch M, Ostelo RW, Knol D, Dekker J, Steultjens MP. Reproducibility of the measurement of knee joint proprioception in patients with osteoarthritis of the knee. Arthritis Rheum. 2007 Dec 15;57(8):1398-403. doi: 10.1002/art.23082.
- Background: PubMed 25682165Jenny JY, Bureggah A, Diesinger Y. Measurement of the knee flexion angle with smartphone applications: Which technology is better? Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2874-2877. doi: 10.1007/s00167-015-3537-4. Epub 2015 Feb 15.
- Background: PubMed 12937561Kaminski TW, Hartsell HD. Factors Contributing to Chronic Ankle Instability: A Strength Perspective. J Athl Train. 2002 Dec;37(4):394-405.
- Background: PubMed 19020196Kimberlin CL, Winterstein AG. Validity and reliability of measurement instruments used in research. Am J Health Syst Pharm. 2008 Dec 1;65(23):2276-84. doi: 10.2146/ajhp070364.
- Background: PubMed 21251988Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.
- Individual participant dataSharing planned: Yes. Individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Rehan Youssef, PhD principal investigator
Cairo University, Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Aliaa Rehan Youssef at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concurrent validity of smartphone against isokinetic dynamometry in measuring joint position sense. (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658915, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.