NCT04026399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 23, 2021

Completed
Last Updated

August 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

July 18, 2019

Results QC Date

July 28, 2021

Last Update Submit

July 28, 2021

Conditions

StrokePhysical Disability

Keywords

physical stimulationSubliminal stimulationstroke rehabilitationupper extremityparesishand functionoccupational therapyphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Short-latency Afferent Inhibition

    motor evoked potential suppression by conditioning electrical stimulation

    1 month

Secondary Outcomes (1)

  • Action Research Arm Test

    1 month

Other Outcomes (26)

  • Stroke Impact Scale Hand Subscale

    1 month

  • Stoke Impact Scale Hand Subscale

    4 month

  • Timing of Reactive Force Generation Per Perturbation

    1 month

  • +23 more other outcomes

Study Arms (2)

stimulation + therapy

EXPERIMENTAL

The participant receives stimulation and home therapy.

Other: peripheral vibration stimulationBehavioral: therapy

no stimulation + therapy

SHAM COMPARATOR

The participant receives no stimulation and receives home therapy.

Behavioral: therapy

Interventions

peripheral vibration stimulationOTHER

wearing a wristband that delivers imperceptible vibratory stimulation.

stimulation + therapy
therapyBEHAVIORAL

practice of daily living tasks

no stimulation + therapystimulation + therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Caorlina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Scronce G, Ramakrishnan V, Vatinno AA, Seo NJ. Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. Stroke Res Treat. 2023 Mar 8;2023:3682898. doi: 10.1155/2023/3682898. eCollection 2023.

    PMID: 36936523DERIVED

MeSH Terms

Conditions

StrokeParesis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Na Jin Seo
Organization
Medical University of South Carolina
seon@musc.edu
8437920084

Study Officials

  • Steven Kautz, PhD

    Medical University of South Carolina

    STUDY CHAIR

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

July 18, 2019

First Posted

July 19, 2019

Study Start

July 8, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

August 23, 2021

Results First Posted

August 23, 2021

Record last verified: 2021-07

Locations

US(1)