Skip to main content
OpenTrials
Completed

NCT Number: NCT04569123

Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

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 Carolina

Charleston, South Carolina, 29403, United States

About this study

Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.

To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old or older
  • At least 6 months since stroke
  • Wolf Motor Function Test (WMFT) total average time >10 seconds
  • WFMT hand task average time <120 s

Exclusion criteria

  • Currently undergoing other upper limb therapy
  • Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
  • Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
  • Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
  • Language barrier or cognitive impairment that precludes following instructions and/or providing consent

Treatment and study plan

Real Stimulation

Device

Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.

No stimulation

Device

Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.

Primary outcomes

  1. Change in Wolf Motor Function Test (WMFT) Movement Time

    Time frame: Baseline and 6 weeks

    The Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks.

    Range: 0 seconds to >120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.

Secondary outcomes

  1. Change in Box and Blocks Test (BBT) Score

    Time frame: Baseline and 6 weeks

    The Box and Blocks Test (BBT) measures unilateral gross manual dexterity. Participants move as many blocks as possible from one side of a box to the other in 60 seconds.

    Range: 0-150 blocks (typical). Interpretation: Higher scores indicate better manual dexterity.

  2. Change in Action Research Arm Test (ARAT) Score

    Time frame: Baseline and 6 weeks

    The Action Research Arm Test (ARAT) is a standardized measure of upper limb functional ability. It contains 19 items scored 0-3, summed to a total score.

    Range: 0-57. Interpretation: Higher scores indicate better upper limb function.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2020
Registry last updated
Feb 9, 2026

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.