Condition category
Nervous System Diseases
Date applied
27/02/2006
Date assigned
22/03/2006
Last edited
26/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.spiegeltraining.de

Contact information

Type

Scientific

Primary contact

Dr Christian Dohle

ORCID ID

Contact details

MEDIAN Klinik Berlin
Department of Neurological Rehabilitation
Charite - University medicine Berlin
Campus Benjamin Franklin
Kladower Damm 223
Berlin
D-14089
Germany
+49 (0)30 36503 105/106
dohle.berlin@median-kliniken.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0315

Study information

Scientific title

Effect of mirror therapy early after stroke: a randomised, single-blinded, placebo-controlled trial

Acronym

Study hypothesis

Patients after a first-ever, single stroke in the middle cerebral artery (MCA) area show a significantly better outcome when treated for six weeks with additional mirror training compared to six weeks of additional training with a direct view of their affected hand.

Ethics approval

Ethics Committee of the Physicians Chamber North Rhein (Arztekammer Nordrhein) (General Medical Council) approved on the 14th July 2004 (ref: 2004189)

Study design

Randomised single-blinded placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Can be found at http://www.refonet.de/projekte/documents/Pat-Information-080924.pdf

Condition

First-ever, single stroke in the MCA territory not more than eight weeks prior to study inclusion

Intervention

Additional occupational therapy for six weeks (30 minutes a day, 5 days a week) - mirror training versus training with a direct view of the affected hand

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Fugl Meyer (FM) score after six weeks of intervention

Secondary outcome measures

1. Action research arm test (ARAT) score after six weeks of intervention
2. Functional independence measure (FIM) score after six weeks of intervention

Overall trial start date

01/07/2004

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. First ever, single stroke in the MCA territory not more than eight weeks prior to study inclusion
2. Aged 30 to 80 years
3. Severe hemiparesis
4. Cardiovascular stability for participation at several therapy units a day
5. Communication level allowing obedience to therapy protocol
6. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Multiple strokes
2. Significant hemorrhagic imbibition
3. Prior hemicranectomy
4. Restricted mobility of the upper extremity by orthopedic, rheumatologic or other concomitant disease

Recruitment start date

01/07/2004

Recruitment end date

31/08/2006

Locations

Countries of recruitment

Germany

Trial participating centre

MEDIAN Klinik Berlin
Berlin
D-14089
Germany

Sponsor information

Organisation

Refonet (Germany)

Sponsor details

Burgweg 3
Bad Neuenahr-Ahrweiler
D-53445
Germany
+49 (0)264 190 620
service@refonet.de

Sponsor type

Industry

Website

http://www.refonet.de

Funders

Funder type

Industry

Funder name

Refonet (Germany) (ref: 3015)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19074686

Publication citations

  1. Results

    Dohle C, Püllen J, Nakaten A, Küst J, Rietz C, Karbe H, Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial., Neurorehabil Neural Repair, 23, 3, 209-217, doi: 10.1177/1545968308324786.

Additional files

Editorial Notes