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

NCT ID: NCT04569123

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2025-01-13

Brief Summary

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

Detailed Description

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.

Conditions

Stroke; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vibration

The device will deliver imperceptible vibration for the treatment group.

Group Type: ACTIVE_COMPARATOR

real stimulation

Intervention Type: 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 Vibration

The device will deliver no vibration for the control group.

Group Type: SHAM_COMPARATOR

No stimulation

Intervention Type: 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.

Interventions

real stimulation

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.

Intervention Type: DEVICE

No stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.

Reference Type: DERIVED

PMID: 35382902 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HD094731-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro90790

Identifier Type: -

Identifier Source: org_study_id