Evaluation of Acupuncture and Attention Training Effects on Patients After Stroke: a Study Protocol of an International Multicentre Study Using a Randomized Single Blinded Three-group Design

Fujian University of Traditional Chinese Medicine3 sites in 3 countries60 target enrollmentNovember 2014

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Fujian University of Traditional Chinese Medicine
Enrollment: 60
Locations: 3
Primary Endpoint: Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether acupuncture and computer-based attention training can be combined for more effective post-stroke attentional deficits.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

January 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian University of Traditional Chinese Medicine

Responsible Party

Principal Investigator

Shanli Yang

Dr.

Fujian University of Traditional Chinese Medicine

Eligibility Criteria

Inclusion Criteria

•Admitted to inpatient stroke rehabilitation within six months after first-ever stroke
•Mild cognitive impairments (attention performance TAP \> 1 standard deviation below mean age-matched norm in at least one subtest).
•Conscious, stable physical condition and signed informed consent of patient.

Exclusion Criteria

•Severe visual and/or hearing problems
•Inability to follow instructions (MoCA)
•Disorders of speech and instruction comprehension (tested with a modified token-test)
•Severe visual and/or hearing problems
•Pre-existing mental disorders - Pregnancy

Outcomes

Primary Outcomes

Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))

Time Frame: Pretest (day 1), Posttest (4 weeks)

Secondary Outcomes

Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks.(Pretest (day 1), Posttest (4 weeks))
Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.(Pretest (day 1), Posttest (4 weeks))
Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks.(Pretest (day 1), Posttest (4 weeks))
Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.(Pretest (day 1), Posttest (4 weeks))
National Institute of Health Stroke Scale (NIH-SS)(Pretest (day 1))
Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.(Pretest (day 1), Posttest (4 weeks))