NCT04050917

Brief Summary

The objective of this study is to determine if the acute effect of vibration from a smartwatch on hand function is comparable to the effect of an existing laboratory prototype.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2019

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

Study Start

First participant enrolled

July 17, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

August 7, 2019

Last Update Submit

March 5, 2020

Conditions

StrokePhysical Disability

Keywords

physical stimulationSubliminal stimulationstroke rehabilitationupper extremityparesishand functionoccupational therapyphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Box and Block Test

    number of blocks moved

    20 minute

Secondary Outcomes (1)

  • Nine Hole Peg Test

    20 minute

Study Arms (2)

Real stimulation

EXPERIMENTAL

The smartwatch produces vibration stimulation.

Device: real stimulation

No stimulation

SHAM COMPARATOR

The smartwatch produces no vibration.

Device: no stimulation

Interventions

real stimulationDEVICE

The smartwatch generates imperceptible vibratory stimulation.

Real stimulation
no stimulationDEVICE

The smartwatch generates no stimulation.

No stimulation

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
  • The ability to perform The Box and Block Test with a score greater than zero and less than 40.

You may not qualify if:

  • Rigidity (Modified Ashworth Scale=5)
  • Complete upper limb deafferentation
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Caorlina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

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

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

August 7, 2019

First Posted

August 9, 2019

Study Start

July 17, 2019

Primary Completion

January 3, 2020

Study Completion

January 3, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)