Physical Therapy ModalitiesNCT05137951
Validity and Reliability of Rebee Sensor to Measure Knee ROM
An observational study of Physical Therapy Modalities, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Physical Therapy Modalities
- What is being tested?
- Rebee sensor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 25 Sep 2021
- 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 30 to 45 years
- All sexes
- Adult
Study population: The participants were recruited from Faculty, staff, and students of Pharos University, Alexandria, Egypt. Graduate Program in Physical Therapy after achieving the inclusion criteria .
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Therapy Modalities
- Being tested
- Rebee sensor
- Keywords
- Rebee Sensor, Digital goniometer, Knee joint Range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebee sensorDevice
Also called Digital goniometer
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 Digital goniometer Goniometry has been described as a tool to measure angle. It gives the physician a useful method to diagnose musculoskeletal function in terms of ROM, monitor the progress of an intervention, record the data for future follow-up, and meet statutory and legal requirements for impairment rating and disability determinations where applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
test Validation of rebee wearable sensor for measuring knee Range of motion
The criterion related validity andof Rebee wearable sensor in measuring active flexion and extension of knee joint ROM compared with digital goniometer measurement.
Measured: day 1
test intrarater reliability of rebee wearable sensor to measure active knee flexion and extension ROM
the procedures was repeated two times with one week interval between measurements. Researcher was recorded all the measurement.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Therapy ModalitiesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Saleh, Cairo University
- Investigators
- Wadida H Abd elkader, PhD, Study director, Professor.dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137951
- Sponsor's protocol ID
- Validity of rebee sensor (PT)
- Status last verified
- Nov 2021
- First submitted
- 3 Oct 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Rebee Wearable Sensor to Measure Knee Joint Range of Motion
- ClinicalTrials.gov ID
- NCT05137951
- Acronym / sponsor ID
- Validity of rebee sensor (PT)
- Conditions
- Physical Therapy Modalities
- Keywords
- Rebee Sensor, Digital goniometer, Knee joint Range of motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 30 Nov 2021 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- The participants were recruited from Faculty, staff, and students of Pharos University, Alexandria, Egypt. Graduate Program in Physical Therapy after achieving the inclusion criteria .
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Rebee sensorAlso: Digital goniometerRebee 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 Digital goniometer Goniometry has been described as a tool to measure angle. It gives the physician a useful method to diagnose musculoskeletal function in terms of ROM, monitor the progress of an intervention, record the data for future follow-up, and meet statutory and legal requirements for impairment rating and disability determinations where applicable | Device | – |
Primary outcome
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.
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.
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 13 Dec 2021.
Related trials for Physical Therapy Modalities
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Active, not recruiting
Eccentric Cycling in Multiple Sclerosis Rehabilitation
Multiple Sclerosis, Rehabilitation
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.
Wadida H Abd elkader, PhD study director
Professor.dr
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 Physical Therapy Modalities, run by Cairo University 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 3 inclusion and 0 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 13 Dec 2021. 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?
test Validation of rebee wearable sensor for measuring knee Range of motion (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2021.