- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291924
Validity and Reliability of a Low-cost Chair Dynamometer
In part 1 of the study, fourteen able-bodied individuals will undergo maximal, voluntary contraction (MVC) test of the lower limbs in two dynamometers. One being a low-cost dynamometer (S2P-CD), and the other being a gold standard dynamometer (HUMAC). Thereby the investigators will be able to assess the validity of the S2P-CD.
In part 2 of the study, eighteen persons with spinal cord injury will undergo MVC twice in the S2P-CD. Thereby the investigators will be able to assess the reliability of the measurements of the S2P-CD.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In part 1 of the study, fourteen able-bodied individuals will undergo maximal, voluntary contraction (MVC) test of the lower limbs in two dynamometers. One being a low-cost dynamometer (S2P-CD), and the other being a gold standard dynamometer (HUMAC). The tests will be carried out with 72-96 hours between them. Thereby the investigators will be able to assess the validity of the S2P-CD.
In part 2 of the study, eighteen persons with spinal cord injury will undergo MVC twice in the S2P-CD. Participants will be recruited through the Spinal Cord Injury Centre of Western Denmark (SCIWDK). The test will be carried out with 30min between them. Thereby the investigators will be able to assess the reliability of the measurements of the S2P-CD.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Viborg, Denmark, 8800
- Spinal Cord Injury Centre of Western Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Ablebodied, healthy volunteers
Spinal cord injured individuals admitted at SCIWDK
Description
Ablebodied individuals:
Inclusion Criteria:
- Age >18 y
Exclusion Criteria:
- Orthopedic or other injuries that may limit maximal muscle strength
Spinal cord injured individuals:
Inclusion Criteria:
- Age > 18 y
- Congenital or acquired spinal cord injury with some degree of preserved muscle function in the lower limbs
Exclusion Criteria:
- Orthopedic or other injuries that may limit maximal muscle strength
- Significant competing diseases
- Severe osteoperosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ablebodied individuals
|
A test for maximal muscle strength and explosive power in the lower limbs
|
|
Spinal Cord Injured Individuals
|
A test for maximal muscle strength and explosive power in the lower limbs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal voluntary contraction
Time Frame: 15min
|
Maximal muscle strength
|
15min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of force development
Time Frame: 15min
|
Explosive muscle strength
|
15min
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Søren K Jensen, MSc, Spinal Cord Injury Centre of Western Denmark
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- VALREL DYNAMOMETER
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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