StrokeNCT03364374
Postural Control and Fine Motor Skills in People With Stroke
An observational study of Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study evaluates the relationship between seated posture and fine motor performance in a drawing task in people with stroke and in healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Postural counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2015to 5 Jul 2016
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients will be recruited from the MUSC Center for Rehabilitation Research in Neurological Conditions database (approved IRB PRO# 15991, PI Kautz) that currently contains contact information for ~120 stroke survivors who have agreed to be contacted for research participation.
Who may be able to join
- experienced uni-hemispheric ischemic or hemorrhagic stroke 3 mo - 7 yrs prior
- ability to grasp and hold a stylus for the duration of the experiments
- passive motion throughout the paretic UE within 20° of normal
- dominant side affected
- no history of stroke or incomplete spinal cord injury
- no medical, orthopedic, neurological, or uncorrected visual condition that would limit the ability to participate in upper extremity testing
Who cannot join
- lesion in brainstem or cerebellum
- presence of other neuro-disease impairing motor skills
- unable to understand 3-step directions
- pain, orthopedic condition or impaired corrected vision that would alter reaching
- Healthy Controls:
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Biomechanical Assessment of the Relationship Between Postural Control and Fine Motor Skills in People With Stroke
This study evaluates the relationship between seated posture and fine motor performance in a drawing task in people with stroke and in healthy control subjects.
Read the detailed description
Current stroke rehabilitation practice guidelines support an interprofessional approach which integrates discipline-specific goals into a comprehensive plan of care. However, there has been a failure to implement interprofessional guidelines into today's stroke rehabilitation clinical practice. Instead it is common that one discipline focuses on recovery of posture, while another discipline focuses on recovery of fine motor skills. The investigators argue that control of the hand is not independent from postural control. In fact, treating them separately ignores the kinematic and muscular linkages connecting the trunk to the hand via the scapula and proximal arm. It also ignores evidence that postural and hand muscles have overlapping cortical representations thus likely have similar neural control networks. Hence, the overall goal of this project is to demonstrate the relationship of posture and fine motor skills to advance stroke rehabilitation.
The study will include two groups, stroke survivors and neurologically healthy controls, and both will perform a tracing task while seated on a backless bench. The task will be performed twice, at baseline and after giving participants cues to improve their posture. Both task repetitions will be performed in a single session on the same day. Kinetic and kinematic data will be collected to evaluate posture, postural stability and fine motor performance. Data collected at baseline will be used to examine the relationship between postural impairments and fine motor deficits. Additionally, we will evaluate the effects of postural cues on body segment alignment, stability and fine motor performance.
- Conditions
- Stroke
- Being tested
- Postural counseling
- Keywords
- Stroke rehabilitation, Upper extremity, Posture
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural counselingBehavioural
A therapist will provide verbal/physical cues to improve the participants posture
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors | Individuals that experienced uni-hemispheric ischemic or hemorrhagic stroke Receives: Behavioral: Postural counseling | |
| Controls | Healthy controls with no history of stroke Receives: Behavioral: Postural counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tracing smoothness from baseline to after postural counseling
Change in the average jerk of the hand trajectory during a tracing task
Measured: Within 24 hours
Secondary outcomes (1)
Change in center of pressure displacement from baseline to after postural counseling
Change in the maximum center of pressure displacement during a tracing task
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start4 Feb 2015
- Primary completion5 Jul 2016
- Study completion5 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Finetto, Medical University of South Carolina
- Investigators
- Christian Finetto, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364374
- Sponsor's protocol ID
- Pro00040824
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of the Relationship Between Postural Control and Fine Motor Skills in People With Stroke
- ClinicalTrials.gov ID
- NCT03364374
- Acronym / sponsor ID
- Pro00040824
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, Upper extremity, Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 4 Feb 2015 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 5 Jul 2016 (actual)
- First posted
- 6 Dec 2017 (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.
This study evaluates the relationship between seated posture and fine motor performance in a drawing task in people with stroke and in healthy control subjects.
Detailed description
Current stroke rehabilitation practice guidelines support an interprofessional approach which integrates discipline-specific goals into a comprehensive plan of care. However, there has been a failure to implement interprofessional guidelines into today's stroke rehabilitation clinical practice. Instead it is common that one discipline focuses on recovery of posture, while another discipline focuses on recovery of fine motor skills. The investigators argue that control of the hand is not independent from postural control. In fact, treating them separately ignores the kinematic and muscular linkages connecting the trunk to the hand via the scapula and proximal arm. It also ignores evidence that postural and hand muscles have overlapping cortical representations thus likely have similar neural control networks. Hence, the overall goal of this project is to demonstrate the relationship of posture and fine motor skills to advance stroke rehabilitation.
The study will include two groups, stroke survivors and neurologically healthy controls, and both will perform a tracing task while seated on a backless bench. The task will be performed twice, at baseline and after giving participants cues to improve their posture. Both task repetitions will be performed in a single session on the same day. Kinetic and kinematic data will be collected to evaluate posture, postural stability and fine motor performance. Data collected at baseline will be used to examine the relationship between postural impairments and fine motor deficits. Additionally, we will evaluate the effects of postural cues on body segment alignment, stability and fine motor performance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors | – | Behavioral: Postural counselingIndividuals that experienced uni-hemispheric ischemic or hemorrhagic stroke |
| Controls | – | Behavioral: Postural counselingHealthy controls with no history of stroke |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients will be recruited from the MUSC Center for Rehabilitation Research in Neurological Conditions database (approved IRB PRO# 15991, PI Kautz) that currently contains contact information for ~120 stroke survivors who have agreed to be contacted for research participation.
Key inclusion criteria (6 listed)
- experienced uni-hemispheric ischemic or hemorrhagic stroke 3 mo - 7 yrs prior
- ability to grasp and hold a stylus for the duration of the experiments
- passive motion throughout the paretic UE within 20° of normal
- dominant side affected
- no history of stroke or incomplete spinal cord injury
Key exclusion criteria (6 listed)
- lesion in brainstem or cerebellum
- presence of other neuro-disease impairing motor skills
- unable to understand 3-step directions
- pain, orthopedic condition or impaired corrected vision that would alter reaching
- none
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 |
|---|---|---|
| Postural counselingA therapist will provide verbal/physical cues to improve the participants posture | Behavioural | Controls, Stroke survivors |
Primary outcome
Change in tracing smoothness from baseline to after postural counseling
Time frame: Within 24 hours
Change in the average jerk of the hand trajectory during a tracing task
1 secondary outcome
Change in center of pressure displacement from baseline to after postural counseling
Time frame: Within 24 hours
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 6 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Christian Finetto, PhD principal investigator
Medical University of South Carolina
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 Stroke, run by Medical University of South Carolina at 1 site in United States.
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 6 inclusion and 6 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 6 Dec 2017. 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 United States. 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?
Change in tracing smoothness from baseline to after postural counseling (time frame: Within 24 hours). 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 6 Dec 2017.