HealthyNCT04578587
Reliability of Hand Held Dynamometer for Assessing Isometric Lumbar Muscle Strength in Asymptomatic Healthy Population
A study testing MicroFET 2 in people with Healthy, run by Fahad Tanveer at 1 site in Pakistan.
Trial summary
To determine intra-rater and inter-rater reliability of hand held dynamometer for assessing isometric lumbar Read more about this study
- Who is it for?
- Ages 21 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MicroFET 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2020to 15 Aug 2020
- Phase
- Interventional
- 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 21 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between twenty one to twenty five years
Who cannot join
- subjects with the history of acute, subacute or chronic low back pain, history of trauma, neurological disorders, spinal surgery, lumbar spine pathology were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
To determine intra-rater and inter-rater reliability of hand held dynamometer for assessing isometric lumbar
Read the detailed description
After being informed about the study and potential risks, all participants given informed consent underwent a 1-week screening period to determine eligibility for study entry. Two raters assessed isometric strength of lumbar flexor and extensor muscles, by a hand-held dynamometer. Strength was measured and recorded by each of the two raters and re-assessed after a week.
- Conditions
- Healthy
- Being tested
- MicroFET 2
- Keywords
- Reliability, Lumbar region, Muscle strength dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroFET 2Device
Lumbar Flexor and Extensor Strength Measurement
| Study group | Role | What they receive |
|---|---|---|
| Rater 1 | Active comparator | Rater 1 Receives: Device: MicroFET 2 |
| Rater 2 | Active comparator | Rater 2 Receives: Device: MicroFET 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand held dynamometer
Muscle Strength
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Jul 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fahad Tanveer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fahad Tanveer, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578587
- Sponsor's protocol ID
- IRB-UOL-FAHS/690/2020
- Status last verified
- Mar 2021
- First submitted
- 2 Oct 2020
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Hand Held Dynamometer for Assessing Isometric Lumbar Muscle Strength in Asymptomatic Healthy Population
- ClinicalTrials.gov ID
- NCT04578587
- Acronym / sponsor ID
- IRB-UOL-FAHS/690/2020
- Conditions
- Healthy
- Keywords
- Reliability, Lumbar region, Muscle strength dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fahad TanveerUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 8 Oct 2020 (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.
To determine intra-rater and inter-rater reliability of hand held dynamometer for assessing isometric lumbar
Detailed description
After being informed about the study and potential risks, all participants given informed consent underwent a 1-week screening period to determine eligibility for study entry. Two raters assessed isometric strength of lumbar flexor and extensor muscles, by a hand-held dynamometer. Strength was measured and recorded by each of the two raters and re-assessed after a week.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rater 1 | Active comparator | Device: MicroFET 2Rater 1 |
| Rater 2 | Active comparator | Device: MicroFET 2Rater 2 |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between twenty one to twenty five years
Key exclusion criteria (1 listed)
- subjects with the history of acute, subacute or chronic low back pain, history of trauma, neurological disorders, spinal surgery, lumbar spine pathology were excluded.
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 |
|---|---|---|
| MicroFET 2Lumbar Flexor and Extensor Strength Measurement | Device | Rater 1, Rater 2 |
Primary outcome
Hand held dynamometer
Time frame: 2 Weeks
Muscle Strength
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 25 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroFET 2 in people with Healthy, run by Fahad Tanveer at 1 site in Pakistan.
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 1 inclusion and 1 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 25 Mar 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 Pakistan. 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?
Hand held dynamometer (time frame: 2 Weeks). 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 25 Mar 2021.