NCT04291924

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

February 27, 2020

Last Update Submit

October 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximal voluntary contraction

    Maximal muscle strength

    15min

Secondary Outcomes (1)

  • Rate of force development

    15min

Study Arms (2)

Ablebodied individuals

Diagnostic Test: Dynamometry

Spinal Cord Injured Individuals

Diagnostic Test: Dynamometry

Interventions

DynamometryDIAGNOSTIC_TEST

A test for maximal muscle strength and explosive power in the lower limbs

Ablebodied individualsSpinal Cord Injured Individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ablebodied, healthy volunteers Spinal cord injured individuals admitted at SCIWDK

You may qualify if:

  • Age \>18 y

You may not qualify if:

  • Orthopedic or other injuries that may limit maximal muscle strength
  • Spinal cord injured individuals:
  • Age \> 18 y
  • Congenital or acquired spinal cord injury with some degree of preserved muscle function in the lower limbs
  • Orthopedic or other injuries that may limit maximal muscle strength
  • Significant competing diseases
  • Severe osteoperosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spinal Cord Injury Centre of Western Denmark

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Søren K Jensen, MSc

    Spinal Cord Injury Centre of Western Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Søren K Jensen, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 2, 2020

Study Start

November 15, 2020

Primary Completion

February 1, 2021

Study Completion

April 1, 2021

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations