Passive Tactile Stimulation for Stroke Rehabilitation (PTS)

Stanford University

Status: Completed

Conditions: Stroke; Spasticity as Sequela of Stroke; Stroke Hemorrhagic; Stroke, Ischemic

Treatments: Device: No vibration; Device: Vibration pattern

Study type: Interventional

Funder types: Other

Identifiers

NCT03814889

49330

Details and patient eligibility

About

Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and older.
• diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
• willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
• able to provide informed consent.

Exclusion criteria

• Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Acute Stimulation: Vibration pattern 1-3 and sham control

Active Comparator group

Description:

All participants try on several wearable prototypes in our laboratory that provide vibration or sham stimulation to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.

Treatment:

Device: No vibration

Device: Vibration pattern

Longitudinal Stimulation: Vibration pattern 4

Active Comparator group

Description:

1) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.

Treatment:

Device: Vibration pattern