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

NCT ID: NCT02324959

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture

Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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).

Computer-based

Computer-based attention training (RehaCom).

Group Type ACTIVE_COMPARATOR

RehaCom

Intervention Type DEVICE

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.

ACoTrain

A combination of computer-based attention training with acupuncture.

Group Type EXPERIMENTAL

RehaCom

Intervention Type DEVICE

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

Intervention Type DEVICE

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).

Interventions

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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.

Intervention Type 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).

Intervention Type DEVICE

Other Intervention Names

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computer-based attention training

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reha Rheinfelden

OTHER

Sponsor Role collaborator

m&i-Fachklinik Herzogenaurach

UNKNOWN

Sponsor Role collaborator

Fujian University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shanli Yang

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, China

Site Status RECRUITING

m&i Fachklinik Herzogenaurach

Herzogenaurach, Bavaria, Germany

Site Status RECRUITING

Reha Rheinfelden

Rheinfelden, Canton of Aargau, Switzerland

Site Status NOT_YET_RECRUITING

Countries

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China Germany Switzerland

Facility Contacts

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Shanli Yang, Dr. Med.

Role: primary

Wilfried Schupp, Dr. med.

Role: primary

Hartwig Kulke, Ph.D.

Role: backup

Michael A. McCaskey, MSc.

Role: primary

Corina Schuster-Amft, PhD PT

Role: backup

References

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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.

Reference Type DERIVED
PMID: 26631161 (View on PubMed)

Other Identifiers

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651

Identifier Type: -

Identifier Source: org_study_id