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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02324959
• Other study ID #: 651
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2014
• Last updated: December 19, 2014
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2014
• Source: Fujian University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionGermany: Ethics CommissionChina: Ministry of Science and TechnologyChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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).

Locations

Country	Name	City	State
China	Fujian University of Traditional Chinese Medicine	Fuzhou	Fujian
Germany	m&i Fachklinik Herzogenaurach	Herzogenaurach	Bavaria
Switzerland	Reha Rheinfelden	Rheinfelden	Aargau

Sponsors (3)

Lead Sponsor	Collaborator
Fujian University of Traditional Chinese Medicine	m&i-Fachklinik Herzogenaurach, Reha Rheinfelden

Countries where clinical trial is conducted

China,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	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