Individuals With Functional Limitations Which May Impact Their Forward ReachNCT05328947
Normative Biomechanical Measures of Reaching in Able-Bodied Adults
A study testing Modified Functional Reach and Functional Reach in people with Individuals With Functional Limitations Which May Impact Their Forward Reach, run by Mayo Clinic at 1 site in United States.
Trial summary
A study to obtain normative values and repeatability measures during functional reaching tasks in able-bodied individuals with no functional limitations. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuals With Functional Limitations Which May Impact Their Forward Reach
- What is being tested?
- Modified Functional Reach and Functional Reach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 29 Jun 2023
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-59 years of age at time of enrollment
Who cannot join
- Failure to give consent or follow simple commands
- Score of 7 or above on the QuickDASH Outcome Measure
- Score of 5 or above on the Oswestry Low Back Disability Questionnaire
- Score of 76 or below on the Lower Extremity Functional Scale
- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis, fibromyalgia)
- Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional vertigo)
- Insufficient active range of motion of bilateral shoulders or hips that results in inability to perform forward or lateral reaching tasks
- Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study
Trial locations and contacts
1 site in 1 country.
About this study
A study to obtain normative values and repeatability measures during functional reaching tasks in able-bodied individuals with no functional limitations.
Read the detailed description
The study has three main aims: 1) Define the data collection methods, and calculate the repeatability, of joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance during seated and standing reaching activities. 2) Collect normative values of joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance during seated and standing functional reaching tasks in 40 participants with no functional limitations. Descriptive statistics will include calculating the mean, median, standard deviation, and range of the outcome variable values. 3) Compare joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance collected during a seated reaching task to those collected during a standing reaching task.
The data collected may be used in the future as baseline reference and repeatability values of outcome measures against which to compare values from individuals with functional limitations to quantify their functional ability.
- Being tested
- Modified Functional Reach and Functional Reach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Functional Reach and Functional ReachOther
Establishment of Modified Functional Reach Test (mFRT) and Function Reach Test (FRT) values for individuals with no functional impairments.
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | Experimental | Not described Receives: Other: Modified Functional Reach and Functional Reach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint angles
Change in measurements of joint angles at the shoulders, hips, knees, and ankles, measured in degrees.
Measured: One data collection session, lasting approximately 4 hours
Electromyography
Muscle activity over time and peak muscle activity, measured in volts. Muscles measured: erector spinae, rectus abdominis, gluteus maximus, gluteus medius, medial hamstring, vastus lateralis, gastrocnemius, and tibialis anterior.
Measured: One data collection session, lasting approximately 4 hours
Center of pressure excursion
Path of movement of the center of pressure applied by the buttocks to the seating surface and applied by the feet to the floor.
Measured: One data collection session, lasting approximately 4 hours
Seated and foot pressures
Plot of pressure magnitude over the surface of the buttocks and the bottom of the feet.
Measured: One data collection session, lasting approximately 4 hours
Reach distance
Measurement of the furthest distance reached, measured in centimeters.
Measured: One data collection session, lasting approximately 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start14 Jul 2022
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals With Functional Limitations Which May Impact Their Forward ReachStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Zhao, PhD, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328947
- Sponsor's protocol ID
- 22-000958
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Biomechanical Measures of Reaching in Able-Bodied Adults
- ClinicalTrials.gov ID
- NCT05328947
- Acronym / sponsor ID
- 22-000958
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 14 Apr 2022 (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.
A study to obtain normative values and repeatability measures during functional reaching tasks in able-bodied individuals with no functional limitations.
Detailed description
The study has three main aims: 1) Define the data collection methods, and calculate the repeatability, of joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance during seated and standing reaching activities. 2) Collect normative values of joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance during seated and standing functional reaching tasks in 40 participants with no functional limitations. Descriptive statistics will include calculating the mean, median, standard deviation, and range of the outcome variable values. 3) Compare joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance collected during a seated reaching task to those collected during a standing reaching task.
The data collected may be used in the future as baseline reference and repeatability values of outcome measures against which to compare values from individuals with functional limitations to quantify their functional ability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | Experimental | Other: Modified Functional Reach and Functional Reach |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-59 years of age at time of enrollment
Key exclusion criteria (8 listed)
- Failure to give consent or follow simple commands
- Score of 7 or above on the QuickDASH Outcome Measure
- Score of 5 or above on the Oswestry Low Back Disability Questionnaire
- Score of 76 or below on the Lower Extremity Functional Scale
- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis, fibromyalgia)
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 |
|---|---|---|
| Modified Functional Reach and Functional ReachEstablishment of Modified Functional Reach Test (mFRT) and Function Reach Test (FRT) values for individuals with no functional impairments. | Other | Normal Controls |
Primary outcome
Joint angles
Time frame: One data collection session, lasting approximately 4 hours
Change in measurements of joint angles at the shoulders, hips, knees, and ankles, measured in degrees.
Electromyography
Time frame: One data collection session, lasting approximately 4 hours
Muscle activity over time and peak muscle activity, measured in volts. Muscles measured: erector spinae, rectus abdominis, gluteus maximus, gluteus medius, medial hamstring, vastus lateralis, gastrocnemius, and tibialis anterior.
Center of pressure excursion
Time frame: One data collection session, lasting approximately 4 hours
Path of movement of the center of pressure applied by the buttocks to the seating surface and applied by the feet to the floor.
Seated and foot pressures
Time frame: One data collection session, lasting approximately 4 hours
Plot of pressure magnitude over the surface of the buttocks and the bottom of the feet.
Reach distance
Time frame: One data collection session, lasting approximately 4 hours
Measurement of the furthest distance reached, measured in centimeters.
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 16 Jul 2024.
- Individual participant dataSharing planned: No
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 Modified Functional Reach and Functional Reach in people with Individuals With Functional Limitations Which May Impact Their Forward Reach, run by Mayo Clinic at 1 site in United States.
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 8 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 16 Jul 2024. 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 United States. 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?
Joint angles (time frame: One data collection session, lasting approximately 4 hours). The study lists 5 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 16 Jul 2024.