NCT03277534

Brief Summary

This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).

Trial Health

100
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 Aug 2013

Typical duration for not_applicable stroke

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

3.4 years

First QC Date

September 5, 2017

Last Update Submit

September 6, 2017

Conditions

Keywords

electrical stimulation

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment for Upper Extremity

    evaluate changes in upper extremity function of the stroke subjects

    before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended

  • EEG-EMG coherence

    evaluate changes in functional connectivity between motor cortex and active muscles

    before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended

Study Arms (2)

Electrical stimulation

EXPERIMENTAL
Other: Electrical stimulation

Control

SHAM COMPARATOR
Other: Sham electrical stimulation

Interventions

sensory electrical stimulation was applied prior to upper limb functional training

Electrical stimulation

electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied

Control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first-ever cerebral cortical region involved chronic stroke, onset over a month,
  • able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and
  • at stable medical condition for intervention

You may not qualify if:

  • history of other neurological disorders,
  • cognitive impairment (Mini-Mental State Examination score \<24, MMSE),26
  • unable to follow orders,
  • contraindications of ES, and
  • under 20 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 11, 2017

Study Start

August 28, 2013

Primary Completion

January 4, 2017

Study Completion

January 4, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09