Medical University of South Caorlina
Charleston, South Carolina, 29425, United States
NCT Number: NCT04026399
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
wearing a wristband that delivers imperceptible vibratory stimulation.
practice of daily living tasks
Time frame: 1 month
motor evoked potential suppression by conditioning electrical stimulation
Time frame: 1 month
standardized clinical upper extremity function score
Time frame: 1 month
standardized patient-reported hand function assessment
Time frame: 4 month
standardized patient-reported hand function assessment
Time frame: 1 month
time of reactive force
Time frame: 4 month
time of reactive force
Time frame: 1 month
standardized clinical upper extremity function score
Time frame: 4 month
standardized clinical upper extremity function score
Time frame: 1 month
angle of the grip force vector from the normal direction
Time frame: 4 month
angle of the grip force vector from the normal direction
Time frame: 1 month
affected hand use amount as measured by accelerometers
Time frame: 4 month
affected hand use amount as measured by accelerometers
Time frame: 1 month
magnitude of reactive grip force
Time frame: 4 month
magnitude of reactive grip force
Time frame: 1 month
additional force used during grip
Time frame: 4 month
additional force used during grip
Time frame: 1 month
motor evoked potential amplitude
Time frame: 4 month
motor evoked potential amplitude
Time frame: 1 month
EEG spectral power perturbation during grip
Time frame: 4 month
EEG spectral power perturbation during grip
Time frame: 1 month
EEG coherence within the sensorimotor network
Time frame: 4 month
EEG coherence within the sensorimotor network
Time frame: 4 month
motor evoked potential suppression by conditioning electrical stimulation
Time frame: 1 month
number of blocks moved in a minute
Time frame: 4 month
number of blocks moved in a minute
Time frame: 1 month
standardized clinical upper extremity function score
Time frame: 4 month
standardized clinical upper extremity function score
Time frame: 4 month
standardized clinical upper extremity function score
Medical University of South Carolina
Other
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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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