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

NCT04569123 | Completed Results DMC

• 2 other identifiers: Pro907901R01HD094731-01A1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Disability; Stroke

Keywords

physical stimulation; subliminal stimulation; stroke rehabilitation; physical therapy; occupational therapy; upper extremity; paresis; hand function

Outcome Measures

Primary Outcomes (1)

• Change in Wolf Motor Function Test (WMFT) Movement Time

  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.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Change in Box and Blocks Test (BBT) Score

  Baseline and 6 weeks

• Change in Action Research Arm Test (ARAT) Score

  Baseline and 6 weeks

Study Arms (2)

Vibration

ACTIVE COMPARATOR

The device will deliver imperceptible vibration for the treatment group.

Device: real stimulation

No Vibration

SHAM COMPARATOR

The device will deliver no vibration for the control group.

Device: No stimulation

Interventions

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.

No Vibration

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.

Vibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

• 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.

  PMID: 35382902 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Na Jin Seo
• Organization: Medical University of South Carolina

seon@musc.edu

8437920084

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: November 2, 2020
• Primary Completion: January 6, 2025
• Study Completion: January 13, 2025
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)