Validity and Reliability of a Low-cost Chair Dynamometer | NCT04291924

Studies
Validity and Reliability of a Low-cost Chair Dynamometer

NCT04291924

Sponsor

Spinal Cord Injury Centre of Western Denmark

Status

Unknown status

Last Update Posted

Oct 27, 2020Actual

Enrollment

32Estimated

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

Dynamometry

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2020Estimated

Primary Completion Date

Feb 1, 2021Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Feb 27, 2020

First Submission Date that Met QC Criteria

Feb 27, 2020

First Posted Date

Mar 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2020

Last Update Posted Date

Oct 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Søren Krogh Jensen, Principal Investigator, Spinal Cord Injury Centre of Western DenmarkPrincipal Investigator

Lead Sponsor

Spinal Cord Injury Centre of Western DenmarkOTHER

Collaborators

Name	Class
University of Aarhus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ablebodied individuals			Diagnostic Test: Dynamometry
Spinal Cord Injured Individuals			Diagnostic Test: Dynamometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dynamometry	Diagnostic Test	A test for maximal muscle strength and explosive power in the lower limbs	Ablebodied individuals Spinal Cord Injured Individuals

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal voluntary contraction	Maximal muscle strength	15min

Secondary Outcomes

Measure	Description	Time Frame
Rate of force development	Explosive muscle strength	15min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Ablebodied, healthy volunteers

Spinal cord injured individuals admitted at SCIWDK

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Søren K Jensen, MSc	Contact	78449854	+45	sokrje@rm.dk

Overall Officials

Name	Affiliation	Role
Søren K Jensen, MSc	Spinal Cord Injury Centre of Western Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spinal Cord Injury Centre of Western Denmark		Viborg		8800	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

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Browse Branches

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