search
Back to results

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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RehaCom
Acupuncture
Sponsored by
Fujian University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian University of Traditional Chinese MedicineRecruiting
  • m&i Fachklinik HerzogenaurachRecruiting
  • Reha Rheinfelden

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Acupuncture

Computer-based

ACoTrain

Arm Description

Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).

Computer-based attention training (RehaCom).

A combination of computer-based attention training with acupuncture.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2014
Last Updated
December 19, 2014
Sponsor
Fujian University of Traditional Chinese Medicine
Collaborators
Reha Rheinfelden, m&i-Fachklinik Herzogenaurach
search

1. Study Identification

Unique Protocol Identification Number
NCT02324959
Brief Title
Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke
Acronym
ACoTrain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian University of Traditional Chinese Medicine
Collaborators
Reha Rheinfelden, m&i-Fachklinik Herzogenaurach

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).
Arm Title
Computer-based
Arm Type
Active Comparator
Arm Description
Computer-based attention training (RehaCom).
Arm Title
ACoTrain
Arm Type
Experimental
Arm Description
A combination of computer-based attention training with acupuncture.
Intervention Type
Device
Intervention Name(s)
RehaCom
Other Intervention Name(s)
computer-based attention training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
Time Frame
Pretest (day 1), Posttest (4 weeks)
Secondary Outcome Measure Information:
Title
Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.
Time Frame
Pretest (day 1), Posttest (4 weeks)
Title
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)
Title
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)
Title
National Institute of Health Stroke Scale (NIH-SS)
Time Frame
Pretest (day 1)
Title
Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.
Time Frame
Pretest (day 1), Posttest (4 weeks)
Title
Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.
Time Frame
Pretest (day 1), Posttest (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fujian University of Traditional Chinese Medicine
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanli Yang, Dr. Med.
Phone
+8613705949762
Email
49688400@qq.com
First Name & Middle Initial & Last Name & Degree
Su Youxin, Dr. Med.
First Name & Middle Initial & Last Name & Degree
Shi Haibin, Dr. Med.
Facility Name
m&i Fachklinik Herzogenaurach
City
Herzogenaurach
State/Province
Bavaria
ZIP/Postal Code
91074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilfried Schupp, Dr. med.
Phone
+419132831035
Email
wilfried.schupp@fachklinik-herzogenaurach.de
First Name & Middle Initial & Last Name & Degree
Hartwig Kulke, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jia Huang, Ph.D.
First Name & Middle Initial & Last Name & Degree
Natalia Madrigal, Dr. med.
Facility Name
Reha Rheinfelden
City
Rheinfelden
State/Province
Aargau
ZIP/Postal Code
4310
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael A. McCaskey, MSc.
Phone
+41618365383
Email
m.mccaskey@reha-rhf.ch
First Name & Middle Initial & Last Name & Degree
Corina Schuster-Amft, PhD PT
Phone
+41618365381
Email
c.schuster@reha-rhf.ch
First Name & Middle Initial & Last Name & Degree
Zorica Suica, MSc. PT

12. IPD Sharing Statement

Citations:
PubMed Identifier
26631161
Citation
Huang J, McCaskey MA, Yang S, Ye H, Tao J, Jiang C, Schuster-Amft C, Balzer C, Ettlin T, Schupp W, Kulke H, Chen L. Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial. Trials. 2015 Dec 2;16:546. doi: 10.1186/s13063-015-1054-x.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs