NCT01781689

Brief Summary

Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism. Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage). This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2012

Longer than P75 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

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

6.8 years

First QC Date

January 27, 2013

Last Update Submit

October 2, 2023

Conditions

Stroke

Keywords

cortical activationmotor functionactivity of daily living

Outcome Measures

Primary Outcomes (1)

  • Cortical activation

    Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months

    weekly changes within 3 months

Secondary Outcomes (1)

  • motor function

    weekly changes within 3 months

Other Outcomes (1)

  • Activity of daily living function

    weekly changes within 3 months

Study Arms (3)

Functional Electric Stimulation

EXPERIMENTAL

perform arm cranking with functional electrical stimulation

Procedure: Functional Electric Stimulation

traditional rehabilitation program

SHAM COMPARATOR

Receive traditional rehabilitation programs

Other: Rehabilitation programs

Health

NO INTERVENTION

with no motor function impairment

Interventions

Functional Electric StimulationPROCEDURE

apply to the hemiplegia affected limbs, helping movement

Functional Electric Stimulation
Rehabilitation programsOTHER

include occupational therapy and physical therapy

traditional rehabilitation program

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
  • Vital sign stable
  • Upper extremity motor function impairment(brunnström stage I\~III)

You may not qualify if:

  • with pacemakers
  • Seizure history
  • Serious dysrhythmias
  • Poor cognition function(MMSE\<13)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zheng-Yu Hoe

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2013

First Posted

February 1, 2013

Study Start

October 1, 2012

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

TW(1)