Basilar Thumb ArthritisNCT03316768
Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production
An observational study of Basilar Thumb Arthritis and Wrist Fracture, run by Shaare Zedek Medical Center.
Trial summary
Very little is known about the pinch and grip forces that are critical for activities of daily living (ADL) or work. Human success in evolution is a result of the combination of great brain power and great hand ability to accomplish with our hands what our minds can conceive. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Basilar Thumb Arthritis, Wrist Fracture, Measure Pressure Distribution and Resultant Forces Needed
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Apr 2020
- 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 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and sex. Helsinki approval will be obtained before recruiting patients. Informed consent will be obtained.
Who may be able to join
- Healthy Volunteers
- At least 18 years old
- Willing to participate in the study
Who cannot join
- History of an inflammatory condition such as rheumatoid arthritis or lupus
- Symptomatic osteoarthritis of their hands
- Known neurologic condition
- Prior injury that may be contributing to weakness or atrophy
About this study
Very little is known about the pinch and grip forces that are critical for activities of daily living (ADL) or work. Human success in evolution is a result of the combination of great brain power and great hand ability to accomplish with our hands what our minds can conceive. Prehensile grasp in hominins allowed tool production and today allows us to hold fine instruments to perform surgery or do heavy construction. The strength of our hands is matched against the requirements of the activities we need to perform. The hypothesis of this study is that many tasks have an inherent strength requirement that is independent of the person performing the task. Until recently, direct measurement of the forces has not been possible. Ultra thin sensors along with the software to interpret the information is now available to make this force determination possible. We have 3 primary objectives. The primary objective is to measure pressure distribution and resultant forces needed for 3 categories of ADL and 2 categories of work in normal subjects. The second objective is to perform a similar evaluation of patients with basilar thumb arthritis and after wrist fracture. The third objective is to measure pressure distribution and forces needed for tool production and use.
Read the detailed description
The study will measure pressures and forces for ADL and simulated work using healthy volunteers. Sixteen volunteers will be chosen over a range of ages but specifically include similar numbers of early adulthood (18-44), middle age (45-65), and elderly (>65). Sixteen volunteers from each age group divided evenly by gender will be selected. Therefore, a total of 48 subjects will be tested, with an even number of male and female performing each of the activities listed above.
Inclusion Critera Volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and gender.
Exclusion Criteria Patients will be excluded if they have a history of an inflammatory condition such as rheumatoid arthritis or lupus. They will be excluded if they have symptomatic osteoarthritis of their hands. Additional exclusion criteria will include known neurologic conditions, or prior injury that may be contributing to weakness or atrophy.
- Conditions
- Basilar Thumb Arthritis, Wrist Fracture, Measure Pressure Distribution and Resultant Forces Needed
- Keywords
- grip, pinch, forces, pressure, Tekscan, sensor, ADL, activities of daily living, work requirements, hand biomechanics, forceful precision grip, power grip, hominid, hominin, prehistoric
- Medical subject headings
- Wrist Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip Strength
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startJan 2020 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar Thumb ArthritisStudies 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
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316768
- Sponsor's protocol ID
- 01D23E57.603E53E0
- Status last verified
- Apr 2018
- First submitted
- 17 Oct 2017
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production
- ClinicalTrials.gov ID
- NCT03316768
- Acronym / sponsor ID
- 01D23E57.603E53E0
- Conditions
- Basilar Thumb Arthritis, Wrist Fracture, Measure Pressure Distribution and Resultant Forces Needed
- Keywords
- grip, pinch, forces, pressure, Tekscan, sensor, ADL, activities of daily living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 20 Oct 2017 (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.
Very little is known about the pinch and grip forces that are critical for activities of daily living (ADL) or work. Human success in evolution is a result of the combination of great brain power and great hand ability to accomplish with our hands what our minds can conceive. Prehensile grasp in hominins allowed tool production and today allows us to hold fine instruments to perform surgery or do heavy construction. The strength of our hands is matched against the requirements of the activities we need to perform. The hypothesis of this study is that many tasks have an inherent strength requirement that is independent of the person performing the task. Until recently, direct measurement of the forces has not been possible. Ultra thin sensors along with the software to interpret the information is now available to make this force determination possible. We have 3 primary objectives. The primary objective is to measure pressure distribution and resultant forces needed for 3 categories of ADL and 2 categories of work in normal subjects. The second objective is to perform a similar evaluation of patients with basilar thumb arthritis and after wrist fracture. The third objective is to measure pressure distribution and forces needed for tool production and use.
Detailed description
The study will measure pressures and forces for ADL and simulated work using healthy volunteers. Sixteen volunteers will be chosen over a range of ages but specifically include similar numbers of early adulthood (18-44), middle age (45-65), and elderly (>65). Sixteen volunteers from each age group divided evenly by gender will be selected. Therefore, a total of 48 subjects will be tested, with an even number of male and female performing each of the activities listed above.
Inclusion Critera Volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and gender.
Exclusion Criteria Patients will be excluded if they have a history of an inflammatory condition such as rheumatoid arthritis or lupus. They will be excluded if they have symptomatic osteoarthritis of their hands. Additional exclusion criteria will include known neurologic conditions, or prior injury that may be contributing to weakness or atrophy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and sex. Helsinki approval will be obtained before recruiting patients. Informed consent will be obtained.
Key inclusion criteria (3 listed)
- Healthy Volunteers
- At least 18 years old
- Willing to participate in the study
Key exclusion criteria (4 listed)
- History of an inflammatory condition such as rheumatoid arthritis or lupus
- Symptomatic osteoarthritis of their hands
- Known neurologic condition
- Prior injury that may be contributing to weakness or atrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grip Strength
Time frame: one day
Grip Strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Basilar Thumb Arthritis and Wrist Fracture, run by Shaare Zedek Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Grip Strength (time frame: one day). 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 5 Apr 2019.