Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke (ACoTrain)

December 19, 2014 updated by: Shanli Yang, Fujian University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350003
        • Recruiting
        • Fujian University of Traditional Chinese Medicine
        • Contact:
          • Shanli Yang, Dr. Med.
          • Phone Number: +8613705949762
          • Email: 49688400@qq.com
        • Sub-Investigator:
          • Su Youxin, Dr. Med.
        • Sub-Investigator:
          • Shi Haibin, Dr. Med.
  • Germany
    • Bavaria
      • Herzogenaurach, Bavaria, Germany, 91074
        • Recruiting
        • m&i Fachklinik Herzogenaurach
        • Contact:
        • Contact:
          • Hartwig Kulke, Ph.D.
        • Sub-Investigator:
          • Jia Huang, Ph.D.
        • Sub-Investigator:
          • Natalia Madrigal, Dr. med.
  • Switzerland
    • Aargau
      • Rheinfelden, Aargau, Switzerland, 4310
        • Not yet recruiting
        • Reha Rheinfelden
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Zorica Suica, MSc. PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupuncture
Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).
Device: Acupuncture
The affected meridian group is treated by needling on Baihui (GV20|DU20) and Shenting (GV24|DU24) - both acupoints of the Governor Vessel. Baihui is 5 cun (1cun=3.33 cm) superior to the anterior hairline on the anterior median line (midpoint of the connecting line between the auricular apices).
Active Comparator: Computer-based
Computer-based attention training (RehaCom).
Device: RehaCom
The computer-based neurorehabilitation program is intended for patients with acquired cognitive deficits after brain damage, e.g. after stroke. The RehaCom software has five different therapeutic groups aimed at restoration of attention, memory, executive functions, and visual field, respectively. Each group has one to four different modules to choose from for each therapy session. Only attention will be trained in this study.
Other Names:
  • computer-based attention training
Experimental: ACoTrain
A combination of computer-based attention training with acupuncture.
Device: Acupuncture
The affected meridian group is treated by needling on Baihui (GV20|DU20) and Shenting (GV24|DU24) - both acupoints of the Governor Vessel. Baihui is 5 cun (1cun=3.33 cm) superior to the anterior hairline on the anterior median line (midpoint of the connecting line between the auricular apices).
Device: RehaCom
The computer-based neurorehabilitation program is intended for patients with acquired cognitive deficits after brain damage, e.g. after stroke. The RehaCom software has five different therapeutic groups aimed at restoration of attention, memory, executive functions, and visual field, respectively. Each group has one to four different modules to choose from for each therapy session. Only attention will be trained in this study.
Other Names:
  • computer-based attention training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
Time Frame: Pretest (day 1), Posttest (4 weeks)
Pretest (day 1), Posttest (4 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian University of Traditional Chinese Medicine

Collaborators

Reha Rheinfelden
m&i-Fachklinik Herzogenaurach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 651 (CHM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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