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

Not Applicable

• Conditions: Stroke
• Interventions: Device: RehaCom; Device: Acupuncture

• Registration Number: NCT02324959
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Status Verified: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-19
• Last Update Submitted: 2014-12-19
• Study First Posted: 2014-12-24
• Last Update Posted: 2014-12-24
• Primary Completion: 2015-11
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACoTrain	RehaCom	A combination of computer-based attention training with acupuncture.
ACoTrain	Acupuncture	A combination of computer-based attention training with acupuncture.
Acupuncture	Acupuncture	Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).
Computer-based	RehaCom	Computer-based attention training (RehaCom).

Primary Outcome Measures

Name	Time	Method
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))	Pretest (day 1), Posttest (4 weeks)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Fujian University of Traditional Chinese Medicine; 🇨🇳 Fuzhou, Fujian, China

Reha Rheinfelden; 🇨🇭 Rheinfelden, Aargau, Switzerland

m&i Fachklinik Herzogenaurach; 🇩🇪 Herzogenaurach, Bavaria, Germany