Trunk StabilityNCT05646966
Trunkstability: a Predisposition for Armfunction
A study testing one time testing in people with Trunk Stability, run by University Ghent at 1 site in Belgium.
Trial summary
Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Trunk Stability
- What is being tested?
- one time testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2016to Jul 2019
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 30
- no orthopedic, neurologic disorder that can influence the reaching
- age between 18 and 70 yrs
Who cannot join
- BMI>30
- orthopedic, neurologic disorder that can influence the reaching
- < 18 yrs of age
- >70 yrs of age
Trial locations and contacts
1 site in 1 country.
About this study
Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.
Read the detailed description
Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone at a distance of little more than armlength.
Electromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.
- Conditions
- Trunk Stability
- Being tested
- one time testing
- Keywords
- stroke, reaching, ADL
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one time testingOther
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Active comparator | healthy subjects Receives: Other: one time testing |
| stroke patients | No intervention | first time stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography to analyze muscle activation
which muscle is active during a reaching movement
Measured: 2 hours
kinematics to analyze trunk involvement
when is the trunk involved in a reaching movement
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study startDec 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trunk StabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646966
- Sponsor's protocol ID
- EC2016/0808
- Status last verified
- Dec 2022
- First submitted
- 13 Jun 2017
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunkstability: a Predisposition for Armfunction
- ClinicalTrials.gov ID
- NCT05646966
- Acronym / sponsor ID
- EC2016/0808
- Conditions
- Trunk Stability
- Keywords
- stroke, reaching, ADL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 12 Dec 2022 (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.
Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.
Detailed description
Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone at a distance of little more than armlength.
Electromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Active comparator | Other: one time testinghealthy subjects |
| stroke patients | No intervention | –first time stroke patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI < 30
- no orthopedic, neurologic disorder that can influence the reaching
- age between 18 and 70 yrs
Key exclusion criteria (4 listed)
- BMI>30
- orthopedic, neurologic disorder that can influence the reaching
- < 18 yrs of age
- >70 yrs of age
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 |
|---|---|---|
| one time testing | Other | healthy subjects |
Primary outcome
Electromyography to analyze muscle activation
Time frame: 2 hours
which muscle is active during a reaching movement
kinematics to analyze trunk involvement
Time frame: 2 hours
when is the trunk involved in a reaching movement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Trunk Stability
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Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke
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Therapeutic Listening for Balance and Trunk Control in Children With Cerebral Palsy
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Muscle Thickness, Trunk Proprioception, and Postural Stability in Rotator Cuff Pathology
Rotator Cuff Injuries
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one time testing in people with Trunk Stability, run by University Ghent at 1 site in Belgium.
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 4 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: finished, as of the sponsor's last update on 12 Dec 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography to analyze muscle activation (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 12 Dec 2022.