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Trial record 1 of 1 for:    NCT02324959
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Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke (ACoTrain)

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ClinicalTrials.gov Identifier: NCT02324959
Recruitment Status : Unknown
Verified December 2014 by Shanli Yang, Fujian University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Collaborators:
Reha Rheinfelden
m&i-Fachklinik Herzogenaurach
Information provided by (Responsible Party):
Shanli Yang, Fujian University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Stroke Device: RehaCom Device: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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 Name: computer-based attention training

Experimental: ACoTrain
A combination of computer-based attention training with acupuncture.
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 Name: computer-based attention training

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).




Primary Outcome Measures :
  1. 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 Measures :
  1. Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks. [ Time Frame: Pretest (day 1), Posttest (4 weeks) ]
  2. 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) ]
  3. 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) ]
  4. National Institute of Health Stroke Scale (NIH-SS) [ Time Frame: Pretest (day 1) ]
  5. Change from baseline in total score of Extended Barthel Index (EBI) at four weeks. [ Time Frame: Pretest (day 1), Posttest (4 weeks) ]
  6. Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks. [ Time Frame: Pretest (day 1), Posttest (4 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324959


Locations
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China, Fujian
Fujian University of Traditional Chinese Medicine Recruiting
Fuzhou, Fujian, China, 350003
Contact: Shanli Yang, Dr. Med.    +8613705949762    49688400@qq.com   
Sub-Investigator: Su Youxin, Dr. Med.         
Sub-Investigator: Shi Haibin, Dr. Med.         
Germany
m&i Fachklinik Herzogenaurach Recruiting
Herzogenaurach, Bavaria, Germany, 91074
Contact: Wilfried Schupp, Dr. med.    +419132831035    wilfried.schupp@fachklinik-herzogenaurach.de   
Contact: Hartwig Kulke, Ph.D.         
Sub-Investigator: Jia Huang, Ph.D.         
Sub-Investigator: Natalia Madrigal, Dr. med.         
Switzerland
Reha Rheinfelden Not yet recruiting
Rheinfelden, Aargau, Switzerland, 4310
Contact: Michael A. McCaskey, MSc.    +41618365383    m.mccaskey@reha-rhf.ch   
Contact: Corina Schuster-Amft, PhD PT    +41618365381    c.schuster@reha-rhf.ch   
Sub-Investigator: Zorica Suica, MSc. PT         
Sponsors and Collaborators
Fujian University of Traditional Chinese Medicine
Reha Rheinfelden
m&i-Fachklinik Herzogenaurach

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanli Yang, Dr., Fujian University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02324959     History of Changes
Other Study ID Numbers: 651
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases