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NCT04291924 Clinical Trial

Validity and Reliability of a Low-cost Chair Dynamometer

Spinal Cord Injuries Clinical Trial

Official title:
Validity and Reliability of a Low-cost Chair Dynamometer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04291924
Other study ID # VALREL DYNAMOMETER
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 15, 2020
Est. completion date April 1, 2021

Study information
Verified date October 2020
Source Spinal Cord Injury Centre of Western Denmark
Contact Søren K Jensen, MSc
Phone 78449854
Email sokrje@rm.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 32
Est. completion date April 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Dynamometry
A test for maximal muscle strength and explosive power in the lower limbs

Locations
Country Name City State
Denmark Spinal Cord Injury Centre of Western Denmark Viborg

Sponsors (2)
Lead Sponsor Collaborator
Spinal Cord Injury Centre of Western Denmark University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximal voluntary contraction Maximal muscle strength 15min
Secondary Rate of force development Explosive muscle strength 15min
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