StrokeACoTrainNCT02324959
Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke
A study testing RehaCom and Acupuncture in people with Stroke, run by Fujian University of Traditional Chinese Medicine at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- RehaCom and Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
China1 site, 1 recruiting
- Recruiting
Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350003
Shanli Yang, Dr. Med., +8613705949762, 49688400@qq.com
Su Youxin, Dr. Med.
Germany1 site, 1 recruiting
- Recruiting
m&i Fachklinik Herzogenaurach
Herzogenaurach, Bavaria, 91074
Wilfried Schupp, Dr. med., +419132831035, wilfried.schupp@fachklinik-herzogenaurach.de
Hartwig Kulke, Ph.D.
Switzerland1 site, 1 recruiting
- Not yet recruiting
Reha Rheinfelden
Rheinfelden, Canton of Aargau, 4310
Michael A. McCaskey, MSc., +41618365383, m.mccaskey@reha-rhf.ch
Corina Schuster-Amft, PhD PT, +41618365381, c.schuster@reha-rhf.ch
About this study
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
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
- Stroke
- Being tested
- RehaCom, Acupuncture
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehaComDevice
Also called computer-based attention training
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.
AcupunctureDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting). Receives: Device: Acupuncture |
| Computer-based | Active comparator | Computer-based attention training (RehaCom). Receives: Device: RehaCom |
| ACoTrain | Experimental | A combination of computer-based attention training with acupuncture. Receives: Device: RehaCom; Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
Measured: Pretest (day 1), Posttest (4 weeks)
Secondary outcomes (6)
Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.
Measured: Pretest (day 1), Posttest (4 weeks)
Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks.
Measured: Pretest (day 1), Posttest (4 weeks)
Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks.
Measured: Pretest (day 1), Posttest (4 weeks)
National Institute of Health Stroke Scale (NIH-SS)
Measured: Pretest (day 1)
Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.
Measured: Pretest (day 1), Posttest (4 weeks)
Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.
Measured: Pretest (day 1), Posttest (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Reha Rheinfelden, m&i-Fachklinik Herzogenaurach
- Responsible party
- Principal investigator, Shanli Yang, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324959
- Sponsor's protocol ID
- 651
- Acronym
- ACoTrain
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26631161
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02324959
- Acronym / sponsor ID
- ACoTrain / 651
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Reha Rheinfelden, m&i-Fachklinik Herzogenaurach
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Device: AcupunctureNeedling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting). |
| Computer-based | Active comparator | Device: RehaComComputer-based attention training (RehaCom). |
| ACoTrain | Experimental | Device: RehaCom, Device: AcupunctureA combination of computer-based attention training with acupuncture. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehaComAlso: computer-based attention trainingThe 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. | Device | ACoTrain, Computer-based |
| AcupunctureThe 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). | Device | ACoTrain, Acupuncture |
Primary outcome
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
Time frame: Pretest (day 1), Posttest (4 weeks)
6 secondary outcomes
Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.
Time frame: Pretest (day 1), Posttest (4 weeks)
Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks.
Time frame: Pretest (day 1), Posttest (4 weeks)
Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks.
Time frame: Pretest (day 1), Posttest (4 weeks)
National Institute of Health Stroke Scale (NIH-SS)
Time frame: Pretest (day 1)
Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.
Time frame: Pretest (day 1), Posttest (4 weeks)
Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.
Time frame: Pretest (day 1), Posttest (4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Derived from this study: PubMed 26631161Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
m&i Fachklinik Herzogenaurach
Herzogenaurach, Germany
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RehaCom and Acupuncture in people with Stroke, run by Fujian University of Traditional Chinese Medicine at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP)) (time frame: Pretest (day 1), Posttest (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.