Clinical trial NCT02324959: Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke
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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Reha Rheinfelden
name: m&i-Fachklinik Herzogenaurach
First posted: 2014-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
timeFrame: Pretest (day 1), Posttest (4 weeks)
Secondary outcomes:
measure: Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.
timeFrame: Pretest (day 1), Posttest (4 weeks)
measure: Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks.
timeFrame: Pretest (day 1), Posttest (4 weeks)
measure: Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks.
timeFrame: Pretest (day 1), Posttest (4 weeks)
measure: National Institute of Health Stroke Scale (NIH-SS)
timeFrame: Pretest (day 1)
measure: Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.
timeFrame: Pretest (day 1), Posttest (4 weeks)
measure: Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.
timeFrame: Pretest (day 1), Posttest (4 weeks)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian University of Traditional Chinese Medicine
state: Fujian
city: Herzogenaurach
country: Germany
facility: m&i Fachklinik Herzogenaurach
state: Bavaria
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
Study officials:
References:
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.