- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328947
Normative Biomechanical Measures of Reaching in Able-Bodied Adults
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 20-59 years of age at time of enrollment
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal Controls
|
Establishment of Modified Functional Reach Test (mFRT) and Function Reach Test (FRT) values for individuals with no functional impairments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One data collection session, lasting approximately 4 hours
|
|
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.
|
One data collection session, lasting approximately 4 hours
|
|
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.
|
One data collection session, lasting approximately 4 hours
|
|
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.
|
One data collection session, lasting approximately 4 hours
|
|
Reach distance
Time Frame: One data collection session, lasting approximately 4 hours
|
Measurement of the furthest distance reached, measured in centimeters.
|
One data collection session, lasting approximately 4 hours
|
Collaborators and Investigators
Sponsor
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
- 22-000958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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