Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Stroke Clinical Trial

Official title:

Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026399
• Other study ID #: Pro00086207
• Secondary ID: P20GM109040
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: July 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic stroke survivor (>= 6 months post stroke)
• Ability to move an object with the paretic hand
• Fingertip sensory deficits
• Ability to put on a watch daily (by oneself or with help)

Exclusion Criteria:

• Currently undergoing other upper extremity rehabilitation therapy
• Upper limb botulinum toxin within 3 months prior to or during enrollment
• Change in neurological disorder medications during the enrollment
• Complete upper limb deafferentation
• Rigidity (Modified Ashworth Scale=5)
• Brainstem stroke
• Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
• Language barrier or cognitive impairment that precludes following instructions and/or providing consent If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.

Related Conditions & MeSH terms

• Physical Disability
• Stroke

Intervention

Other:
• peripheral vibration stimulation
wearing a wristband that delivers imperceptible vibratory stimulation.

Behavioral:
• therapy
practice of daily living tasks

Locations

Country	Name	City	State
United States	Medical University of South Caorlina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stroke Impact Scale Hand Subscale	standardized patient-reported hand function assessment	1 month
Other	Stoke Impact Scale Hand Subscale	standardized patient-reported hand function assessment	4 month
Other	Timing of Reactive Force Generation Per Perturbation	time of reactive force	1 month
Other	Timing of Reactive Force Generation Per Perturbation	time of reactive force	4 month
Other	Fugl-Meyer Upper Limb Assessment	standardized clinical upper extremity function score	1 month
Other	Fugl-Meyer Upper Limb Assessment	standardized clinical upper extremity function score	4 month
Other	Grip Force Direction	angle of the grip force vector from the normal direction	1 month
Other	Grip Force Direction	angle of the grip force vector from the normal direction	4 month
Other	In-home Hand Use Amount	affected hand use amount as measured by accelerometers	1 month
Other	In-home Hand Use Amount	affected hand use amount as measured by accelerometers	4 month
Other	Reactive Force Magnitude Per Perturbation	magnitude of reactive grip force	1 month
Other	Reactive Force Magnitude Per Perturbation	magnitude of reactive grip force	4 month
Other	Safety Margin	additional force used during grip	1 month
Other	Safety Margin	additional force used during grip	4 month
Other	Corticomotor Excitability	motor evoked potential amplitude	1 month
Other	Corticomotor Excitability	motor evoked potential amplitude	4 month
Other	Spectral Power Perturbation During Grip	EEG spectral power perturbation during grip	1 month
Other	Spectral Power Perturbation During Grip	EEG spectral power perturbation during grip	4 month
Other	Connectivity	EEG coherence within the sensorimotor network	1 month
Other	Connectivity	EEG coherence within the sensorimotor network	4 month
Other	Short-latency Afferent Inhibition	motor evoked potential suppression by conditioning electrical stimulation	4 month
Other	Box and Block Test	number of blocks moved in a minute	1 month
Other	Box and Block Test	number of blocks moved in a minute	4 month
Other	Wolf Motor Function Test	standardized clinical upper extremity function score	1 month
Other	Wolf Motor Function Test	standardized clinical upper extremity function score	4 month
Other	Action Research Arm Test	standardized clinical upper extremity function score	4 month
Primary	Short-latency Afferent Inhibition	motor evoked potential suppression by conditioning electrical stimulation	1 month
Secondary	Action Research Arm Test	standardized clinical upper extremity function score	1 month