NCT Number: NCT04308629
Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke
Stroke is the leading cause of disability and diminished quality of living that frequently includes impairments of postural control and upper extremity (UE) function. The interaction of posture and UE coupling in terms of movement planning, initiation, and execution is not well understood. StartReact responses triggered by a loud acoustic stimulus (LAS) during the planning and preparation of goal intended actions has been used to probe the state of brainstem neuronal excitability related to posture and movement sequencing. The purpose of this study is to examine posture and goal-directed movement planning and execution using startReact responses and to evaluate posture and UE movement sequence during reaching while standing in individuals with chronic hemiparesis and healthy controls. Secondly, the investigators will determine the modulatory role of the cortical premotor areas (PMAs) in startReact responses in healthy controls and in persons with stroke by using transcranial direct current stimulation (tDCS) to up- or down-regulate PMAs excitability.
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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for stroke:
- Unilateral cortical or white matter subcortical stroke
- Age 40 yrs and older
- ≥ 6 months post ischemic stroke or ≥ 12 months post hemorrhagic stroke
- Residual arm hemiparesis as indicated by Fugl-Meyer Upper Extremity score between 20-65
- Having the ability to perform reaching movements with the paretic arm in standing without an assistive device.
Exclusion criteria
for stroke:
- Stroke involving bilateral hemisphere, brainstem or cerebellum
- Any medical condition precluding participation in testing
- Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.
Inclusion criteria
for healthy controls:
- Age-matched to the stroke subjects
- Without a history of stroke or any known neurological conditions
- Having the cognitive ability to follow two-step commands and give informed consent
Exclusion criteria
for healthy controls:
- Any medical condition precluding participation in testing
- Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.
Participants were also excluded if they did not meet the TMS safety criterion including having implantable medical devices, history of seizures, taking medications to reduce anxiety, sedatives, and seizure, and pregnancy.
Treatment and study plan
Primary outcomes
-
Change in startReact response
Time frame: Immediately after the intervention (one session tDCS)
The incidence of StartReact response following an loud acoustic stimulus
-
Change in the lag between anticipatory postural adjustments and reach onset
Time frame: Immediately after the intervention (one session tDCS)
The temporal lag between anticipatory postural adjustments (APA) onset and reach onset (unit: seconds)
Secondary outcomes
-
Change in the reach onset (unit: seconds)
Time frame: Immediately after the intervention (one session tDCS)
The onset of the anterior wrist joint center movement with a threshold of 5% peak velocity
-
Change in the APA onset (unit: seconds)
Time frame: Immediately after the intervention (one session tDCS)
The onset of the posterior center of pressure displacement with a threshold of 5% peak velocity
-
Change in the amount of trunk flexion (unit: radians)
Time frame: Immediately after the intervention(one session tDCS)
The angular displacement of the line joining the reaching shoulder and the hip joint center on the same side in the sagittal plane at maximum reach normalized by reach distance
-
Change in the amount of trunk rotation (unit: radians)
Time frame: Immediately after the intervention (one session tDCS)
The angular displacement of the line connecting both shoulders in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance
-
Change in the amount of pelvic rotation (unit: radians)
Time frame: Immediately after the intervention (one session tDCS)
The angular displacement of the line connecting both hip joint centers in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance
-
Change in the amount of trunk-pelvic rotation difference (unit: radians)
Time frame: Immediately after the intervention (one session tDCS)
The difference between trunk and pelvic angular displacement at maximum reach normalized by reach distance
Sponsors and collaborators
Lead sponsor
University of Maryland, Baltimore
Other
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 16, 2020
- Registry last updated
- Mar 16, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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