- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137951
Validity and Reliability of Rebee Sensor to Measure Knee ROM
Validity and Reliability of Rebee Wearable Sensor to Measure Knee Joint Range of Motion
This study was conducted to investigate:
The criterion related validity of Rebee wearable sensor in measuring active flexion and extension of knee joint ROM compared with digital goniometer measurement.
The intra-rater reliability of Rebee wearable sensor in measuring active flexion and extension of knee joint ROM compared with digital goniometer measurement.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Range of Motion (ROM) of the joint is one of the factors that determine function of the musculoskeletal system. This parameter should be measured and recorded by a valid and reliable method . It is considered to be an essential component of lower limb physical examination, which can be applied using various instruments such as goniometers and inclinometers .
Range of motion of the knee joint is one of the major factors determining the outcome after knee injuries. It is also an important measurement required by many knee scoring systems to determine the preoperative status and postoperative outcome .
Measurements are used by physical therapists to quantify limitations of motion, it used to decide an appropriate therapeutic interventions and document the effectiveness of these interventions. The ideal measuring device should give reproducible valid and reliable data .It is required an essential skill in the musculoskeletal assessments commonly performed by physiotherapists.
Two-arm digital goniometer is still widely used in measuring uniaxial ROM of the joint of extremity, there is high validity, intra- rater and inter-rater reliability of the digital goniometer. It is considered valid and reliable tool that simplify physical therapists' work .The digital goniometer is the most commonly utilized clinical tool for measuring joint range of motion, the evolution of sensors technology and applications are easy to use, relatively inexpensive, and highly accessible .
Rebee is a wearable motion sensor package of sensor with its own mobile application, which measures range of joint movement in different planes easily which the patient able to wear the sensor and move easily to measure ROM and record the measurement at the application software, that is facilitate the tele-measurement which the patients are supposed to put on the sensors and perform the actions themselves, or with assistance from physical therapist.
There is lack in the literature about using Rebee wearable sensor in measuring the range of knee joint so this study was conducted to test the criterion related validity and intrarater reliability of the rebee wearable sensor in measuring active knee joint ROM compared with digital goniometer measurement.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alexandria, Egypt, 21500
- Pharos university at alexandria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Forty normal participant's age ranged from 30 to 45.
- The participant from both sex.
- Participant Body mass index (BMI) from (19 to 25) normal weight (BMI= weight (kg) / [height (m)] 2)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
test Validation of rebee wearable sensor for measuring knee Range of motion
Time Frame: day 1
|
The criterion related validity andof Rebee wearable sensor in measuring active flexion and extension of knee joint ROM compared with digital goniometer measurement.
|
day 1
|
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test intrarater reliability of rebee wearable sensor to measure active knee flexion and extension ROM
Time Frame: day 1
|
the procedures was repeated two times with one week interval between measurements.
Researcher was recorded all the measurement.
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wadida H Abd elkader, PhD, Professor.dr
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Validity of rebee sensor (PT)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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