NCT03473808

Brief Summary

After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable stroke

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

First Submitted

Initial submission to the registry

March 5, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 5, 2018

Results QC Date

January 8, 2019

Last Update Submit

March 1, 2019

Conditions

Stroke

Keywords

Hand FunctionOccupational TherapyPhysical Stimulation

Outcome Measures

Primary Outcomes (2)

  • Mean Change in Hand Motor Function

    Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.

    Baseline to approximately 1 week after the completion of 18 therapy sessions.

  • Mean Change in Hand Motor Function

    Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.

    Baseline to approximately 4 weeks after the completion of 18 therapy sessions.

Secondary Outcomes (2)

  • Mean Change in Hand Motor Function

    Baseline to approximately 1 week after the completion of 18 therapy sessions.

  • Mean Change in Hand Motor Function

    Baseline to approximately 4 weeks after the completion of 18 therapy sessions.

Study Arms (1)

therapy + vibration

EXPERIMENTAL

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Behavioral: task-practice therapyOther: Vibration

Interventions

task-practice therapyBEHAVIORAL

Standardized hand therapy program

therapy + vibration
VibrationOTHER

Peripheral vibration applied to the wrist skin at an imperceptible level

therapy + vibration

Eligibility Criteria

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

You may qualify if:

  • Age = 18 or older
  • At least 6 months post-stroke
  • Moderate upper limb impairment with the ability to participate in hand task practices
  • Fingertip touch sensory deficits (e.g., Monofilament\>2.83, 2-point discrimination\>5mm, sense of numbness, tingling)

You may not qualify if:

  • Complete upper limb deafferentation
  • Rigidity (Modified Ashworth Scale=5)
  • Botulinum toxin injection within 3 months prior to enrollment or during enrollment
  • 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)
  • Concurrent upper extremity rehabilitation therapy
  • Language barrier or cognitive impairment that precludes following instructions or providing consent
  • MRI incompatible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Vibration

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Results Point of Contact

Title
Amanda Vatinno
Organization
Medical University of South Carolina
vatinno@musc.edu
8437924840

Study Officials

  • Steve Kautz, PhD

    Medical University of South Carolina

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 22, 2018

Study Start

March 7, 2018

Primary Completion

September 24, 2018

Study Completion

September 24, 2018

Last Updated

March 5, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)