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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Acupuncture Device
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Acupuncture
    Description: Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).
    ARM 2: Kind: Experimental
    Label: ACoTrain
    Description: A combination of computer-based attention training with acupuncture.
  • RehaCom Device
    Other Names: computer-based attention training
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Computer-based
    Description: Computer-based attention training (RehaCom).
    ARM 2: Kind: Experimental
    Label: ACoTrain
    Description: A combination of computer-based attention training with acupuncture.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP)) Pretest (day 1), Posttest (4 weeks) No
Secondary Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks. Pretest (day 1), Posttest (4 weeks) No
Secondary Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks. Pretest (day 1), Posttest (4 weeks) No
Secondary Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks. Pretest (day 1), Posttest (4 weeks) No
Secondary National Institute of Health Stroke Scale (NIH-SS) Pretest (day 1) No
Secondary Change from baseline in total score of Extended Barthel Index (EBI) at four weeks. Pretest (day 1), Posttest (4 weeks) No
Secondary Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks. Pretest (day 1), Posttest (4 weeks) No

Sponsors