StrokeNCT04503187
Motor Skill Acquisition Between Individuals With Neurological Disorders and Healthy Individuals
An observational study of Stroke and Multiple Sclerosis, run by Texas Woman's University at 1 site in United States.
Trial summary
Stroke survivors frequently show persistent gait deficits in their chronic stages even after years of intensive rehabilitation. This may be caused by diminished capability of re-acquiring motor skills post stroke. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke, Multiple Sclerosis
- What is being tested?
- Visuomotor leg reaching task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2013to 31 Dec 2024
- 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 21 to 90 years
- All sexes
- Adult, Older adult
Study population: Three cohorts, including individuals with chronic stroke and multiple sclerosis, and healthy adults.will be recruited via research flyers from communities around Great Houston areas in Texas.
Who may be able to join
- Healthy adults have no ongoing neurological, musculoskeletal issues.
- Individuals with chronic stroke had medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment.
- Individuals have multiple sclerosis disease diagnosed by his/her physician
- MRI or CT evidence from the imaging report shown that the stroke and multiple sclerosis disease primarily involve cortical and subcortical regions.
- Individuals with chronic stroke have hemiparesis involving the lower extremity.
- Individuals with chronic stroke or multiple sclerosis have no passive range of motion limitation in bilateral hips and knees. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less.
Show all 10Show fewer
- Visual acuity can be corrected by glasses or contact lens to 20/20.
- Able to walk independently with/without assistant devices for 10 meters.
- Able to maintain standing position without any assistance for more than 30 sec.
- Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24.
Who cannot join
- Pregnant women.
- MRI or CT evidence of involvement of the basal ganglia or cerebellum, or evidence of any other brain damage or malignant neoplasm or tumors.
- Have any metal implants, cardiac pacemakers, or history of seizures.
- Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training.
- Any vestibular dysfunction or unstable angina.
- Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia*
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Woman's University
Houston, Texas, 77030
Shih-Chiao Tseng, PT, PhD, 703-794-2309, stseng@twu.edu
About this study
Official title: Comparison of Motor Skill Acquisition Between Individuals With Neurological Disorders
Stroke survivors frequently show persistent gait deficits in their chronic stages even after years of intensive rehabilitation. This may be caused by diminished capability of re-acquiring motor skills post stroke. Thus, the overall purpose of this research project is to examine stroke survivors' capability of learning a novel leg task over 3 visits, 1-2 weeks apart. The capability of learning a new skill is then correlated with the individual's neurological functions (nerve activity and movement coordination) and her/his gait performance (gait speed, gait symmetry, and force production).
Read the detailed description
The walking after stroke called "hemiparetic gait" is characterized by slow and asymmetrical steps with poor motor control on the paretic leg while paradoxically increasing the cost of energy expenditure. Biomechanical evidence shows that impaired gait performance for people with chronic stroke is not solely the result of the loss of muscle strength, but involves complicated movement discoordination across multiple joints in the affected leg. This has been taken to indicate a persistent motor control deficit in the paretic leg post stroke. Recent imaging studies suggest that the persistent motor control deficit after stroke may be the result of the disruption of motor memory consolidation, a process by which a newly-learned motor skill is transformed from a fragile state to a stable state and is "saved" in our brain afterward. This indicates that the same brain area responsible for controlling motor activity is also involved in memorizing newly-learned skills during the early stage of motor learning. Presence of persistent motor control deficits in the chronic stage may be attributed to the fact that damage to the brain cortex significantly impacts the ability of acquiring motor skills and consequentially defers the improvement of motor function, including gait.
- Conditions
- Stroke, Multiple Sclerosis
- Being tested
- Visuomotor leg reaching task
- Medical subject headings
- Stroke, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuomotor leg reaching taskBehavioural
Also called Leg reaching task
Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Stroke | Participants who suffered a single event of cerebral vascular accident at least six months ago before study enrollment. Receives: Behavioral: Visuomotor leg reaching task | |
| Multiple Sclerosis | Participants who has been diagnosed with multiple sclerosis Receives: Behavioral: Visuomotor leg reaching task | |
| Healthy control | Age-matched healthy adults who are self-reported healthy and has no known musculoskeletal, neuromuscular, and cardiovascular diseases. Receives: Behavioral: Visuomotor leg reaching task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in movement errors
Average movement error will be calculated as the angular deviation of the foot path from a straight line path to the target at the time of peak velocity in each trial.
Measured: During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session
Peripheral nerve activity
A surface electrode will be placed on the calf muscle in one leg. Then a low-intensity of electrical stimulation will be delivered to a nerve behind the knee to trigger the motor responses.
Measured: During the first session of learning visuomotor leg reaching task
Secondary outcomes (3)
Walking performance
Gait speed will be calculated during overground walking
Measured: Before the first session of learning visuomotor leg reaching task
Mini-mental State Examination
A standardized questionnaires to evaluate the cognitive function consisting of 11 items with a possible summed score ranging from zero to 30. The most widely accepted and frequently used cutoff score for the MMSE is 23, with scores of 23 or lower indicating the presence of cognitive impairment. A higher score means a better cognitive function.
Measured: Before the first session of learning visuomotor leg reaching task
Fugl-Meyer Lower Extremity Function Assessment
A standardized questionnaires to evaluate the lower extremity motor function consisting of movement, coordination, and reflex assessments at hip, knee, and ankle. Possible summed scores range from zero to 34. Higher scores indicate higher and better motor function.
Measured: Before the first session of learning visuomotor leg reaching task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start4 Apr 2013
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Chiao Tseng, Texas Woman's University
- Investigators
- Shih-Chiao Tseng, PT, PhD, Principal investigator, Texas Woman's University School of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503187
- Sponsor's protocol ID
- TWU Houston#17203
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- 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 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Motor Skill Acquisition Between Individuals With Neurological Disorders
- ClinicalTrials.gov ID
- NCT04503187
- Acronym / sponsor ID
- TWU Houston#17203
- Conditions
- Stroke, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 4 Apr 2013 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Aug 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.
Stroke survivors frequently show persistent gait deficits in their chronic stages even after years of intensive rehabilitation. This may be caused by diminished capability of re-acquiring motor skills post stroke. Thus, the overall purpose of this research project is to examine stroke survivors' capability of learning a novel leg task over 3 visits, 1-2 weeks apart. The capability of learning a new skill is then correlated with the individual's neurological functions (nerve activity and movement coordination) and her/his gait performance (gait speed, gait symmetry, and force production).
Detailed description
The walking after stroke called "hemiparetic gait" is characterized by slow and asymmetrical steps with poor motor control on the paretic leg while paradoxically increasing the cost of energy expenditure. Biomechanical evidence shows that impaired gait performance for people with chronic stroke is not solely the result of the loss of muscle strength, but involves complicated movement discoordination across multiple joints in the affected leg. This has been taken to indicate a persistent motor control deficit in the paretic leg post stroke. Recent imaging studies suggest that the persistent motor control deficit after stroke may be the result of the disruption of motor memory consolidation, a process by which a newly-learned motor skill is transformed from a fragile state to a stable state and is "saved" in our brain afterward. This indicates that the same brain area responsible for controlling motor activity is also involved in memorizing newly-learned skills during the early stage of motor learning. Presence of persistent motor control deficits in the chronic stage may be attributed to the fact that damage to the brain cortex significantly impacts the ability of acquiring motor skills and consequentially defers the improvement of motor function, including gait.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Stroke | – | Behavioral: Visuomotor leg reaching taskParticipants who suffered a single event of cerebral vascular accident at least six months ago before study enrollment. |
| Multiple Sclerosis | – | Behavioral: Visuomotor leg reaching taskParticipants who has been diagnosed with multiple sclerosis |
| Healthy control | – | Behavioral: Visuomotor leg reaching taskAge-matched healthy adults who are self-reported healthy and has no known musculoskeletal, neuromuscular, and cardiovascular diseases. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Three cohorts, including individuals with chronic stroke and multiple sclerosis, and healthy adults.will be recruited via research flyers from communities around Great Houston areas in Texas.
Key inclusion criteria (10 listed)
- Healthy adults have no ongoing neurological, musculoskeletal issues.
- Individuals with chronic stroke had medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment.
- Individuals have multiple sclerosis disease diagnosed by his/her physician
- MRI or CT evidence from the imaging report shown that the stroke and multiple sclerosis disease primarily involve cortical and subcortical regions.
- Individuals with chronic stroke have hemiparesis involving the lower extremity.
Key exclusion criteria (6 listed)
- Pregnant women.
- MRI or CT evidence of involvement of the basal ganglia or cerebellum, or evidence of any other brain damage or malignant neoplasm or tumors.
- Have any metal implants, cardiac pacemakers, or history of seizures.
- Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training.
- Any vestibular dysfunction or unstable angina.
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 |
|---|---|---|
| Visuomotor leg reaching taskAlso: Leg reaching taskSimilar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard. | Behavioural | Chronic Stroke, Healthy control, Multiple Sclerosis |
Primary outcome
Changes in movement errors
Time frame: During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session
Average movement error will be calculated as the angular deviation of the foot path from a straight line path to the target at the time of peak velocity in each trial.
Peripheral nerve activity
Time frame: During the first session of learning visuomotor leg reaching task
A surface electrode will be placed on the calf muscle in one leg. Then a low-intensity of electrical stimulation will be delivered to a nerve behind the knee to trigger the motor responses.
3 secondary outcomes
Walking performance
Time frame: Before the first session of learning visuomotor leg reaching task
Mini-mental State Examination
Time frame: Before the first session of learning visuomotor leg reaching task
Fugl-Meyer Lower Extremity Function Assessment
Time frame: Before the first session of learning visuomotor leg reaching task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
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
Recruiting
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.
Shih-Chiao Tseng, PT, PhD principal investigator
Texas Woman's University School of Physical Therapy
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 and Multiple Sclerosis, run by Texas Woman's University 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 10 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: status not confirmed, as of the sponsor's last update on 7 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chiao Tseng, PT, PhD (713-794-2309, stseng@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in movement errors (time frame: During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session). 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 7 Aug 2020.