Spinal Cord InjuriesNCT04291924
Validity and Reliability of a Low-cost Chair Dynamometer
An observational study of Spinal Cord Injuries, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Dynamometry
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ablebodied, healthy volunteers Spinal cord injured individuals admitted at SCIWDK
Who may be able to join
- Age >18 y
- Age > 18 y
- Congenital or acquired spinal cord injury with some degree of preserved muscle function in the lower limbs
Who cannot join
- Orthopedic or other injuries that may limit maximal muscle strength
- Spinal cord injured individuals:
- Orthopedic or other injuries that may limit maximal muscle strength
- Significant competing diseases
- Severe osteoperosis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Spinal Cord Injury Centre of Western Denmark
Viborg, 8800
Søren K Jensen, MSc, 78449854 ext. +45, sokrje@rm.dk
Søren Krogh Jensen, MSc
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Dynamometry
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamometryDiagnostic test
A test for maximal muscle strength and explosive power in the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Ablebodied individuals | Not described Receives: Diagnostic Test: Dynamometry | |
| Spinal Cord Injured Individuals | Not described Receives: Diagnostic Test: Dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary contraction
Maximal muscle strength
Measured: 15min
Secondary outcomes (1)
Rate of force development
Explosive muscle strength
Measured: 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start15 Nov 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinal Cord Injury Centre of Western Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Søren Krogh Jensen, Spinal Cord Injury Centre of Western Denmark
- Investigators
- Søren K Jensen, MSc, Principal investigator, Spinal Cord Injury Centre of Western Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291924
- Sponsor's protocol ID
- VALREL DYNAMOMETER
- Status last verified
- Oct 2020
- First submitted
- 27 Feb 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of a Low-cost Chair Dynamometer
- ClinicalTrials.gov ID
- NCT04291924
- Acronym / sponsor ID
- VALREL DYNAMOMETER
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Spinal Cord Injury Centre of Western DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablebodied individuals | – | Diagnostic Test: Dynamometry |
| Spinal Cord Injured Individuals | – | Diagnostic Test: Dynamometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ablebodied, healthy volunteers Spinal cord injured individuals admitted at SCIWDK
Key inclusion criteria (3 listed)
- Age >18 y
- Age > 18 y
- Congenital or acquired spinal cord injury with some degree of preserved muscle function in the lower limbs
Key exclusion criteria (5 listed)
- Orthopedic or other injuries that may limit maximal muscle strength
- Orthopedic or other injuries that may limit maximal muscle strength
- Significant competing diseases
- Severe osteoperosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynamometryA test for maximal muscle strength and explosive power in the lower limbs | Diagnostic test | Ablebodied individuals, Spinal Cord Injured Individuals |
Primary outcome
Maximal voluntary contraction
Time frame: 15min
Maximal muscle strength
1 secondary outcome
Rate of force development
Time frame: 15min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury
Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren K Jensen, MSc principal investigator
Spinal Cord Injury Centre of Western Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Søren K Jensen, MSc (78449854 ext. +45, sokrje@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal voluntary contraction (time frame: 15min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.