Skip to main content
OpenTrials
Completed

NCT Number: NCT04026399

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Caorlina

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peripheral vibration stimulation

Other

wearing a wristband that delivers imperceptible vibratory stimulation.

Therapy

Behavioral

practice of daily living tasks

Primary outcomes

  1. Short-latency Afferent Inhibition

    Time frame: 1 month

    motor evoked potential suppression by conditioning electrical stimulation

Secondary outcomes

  1. Action Research Arm Test

    Time frame: 1 month

    standardized clinical upper extremity function score

Other outcomes

  1. Stroke Impact Scale Hand Subscale

    Time frame: 1 month

    standardized patient-reported hand function assessment

  2. Stoke Impact Scale Hand Subscale

    Time frame: 4 month

    standardized patient-reported hand function assessment

  3. Timing of Reactive Force Generation Per Perturbation

    Time frame: 1 month

    time of reactive force

  4. Timing of Reactive Force Generation Per Perturbation

    Time frame: 4 month

    time of reactive force

  5. Fugl-Meyer Upper Limb Assessment

    Time frame: 1 month

    standardized clinical upper extremity function score

  6. Fugl-Meyer Upper Limb Assessment

    Time frame: 4 month

    standardized clinical upper extremity function score

  7. Grip Force Direction

    Time frame: 1 month

    angle of the grip force vector from the normal direction

  8. Grip Force Direction

    Time frame: 4 month

    angle of the grip force vector from the normal direction

  9. In-home Hand Use Amount

    Time frame: 1 month

    affected hand use amount as measured by accelerometers

  10. In-home Hand Use Amount

    Time frame: 4 month

    affected hand use amount as measured by accelerometers

  11. Reactive Force Magnitude Per Perturbation

    Time frame: 1 month

    magnitude of reactive grip force

  12. Reactive Force Magnitude Per Perturbation

    Time frame: 4 month

    magnitude of reactive grip force

  13. Safety Margin

    Time frame: 1 month

    additional force used during grip

  14. Safety Margin

    Time frame: 4 month

    additional force used during grip

  15. Corticomotor Excitability

    Time frame: 1 month

    motor evoked potential amplitude

  16. Corticomotor Excitability

    Time frame: 4 month

    motor evoked potential amplitude

  17. Spectral Power Perturbation During Grip

    Time frame: 1 month

    EEG spectral power perturbation during grip

  18. Spectral Power Perturbation During Grip

    Time frame: 4 month

    EEG spectral power perturbation during grip

  19. Connectivity

    Time frame: 1 month

    EEG coherence within the sensorimotor network

  20. Connectivity

    Time frame: 4 month

    EEG coherence within the sensorimotor network

  21. Short-latency Afferent Inhibition

    Time frame: 4 month

    motor evoked potential suppression by conditioning electrical stimulation

  22. Box and Block Test

    Time frame: 1 month

    number of blocks moved in a minute

  23. Box and Block Test

    Time frame: 4 month

    number of blocks moved in a minute

  24. Wolf Motor Function Test

    Time frame: 1 month

    standardized clinical upper extremity function score

  25. Wolf Motor Function Test

    Time frame: 4 month

    standardized clinical upper extremity function score

  26. Action Research Arm Test

    Time frame: 4 month

    standardized clinical upper extremity function score

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2019
Registry last updated
Aug 23, 2021

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.

Published trials that share one or more normalized conditions with this study.