Promotion of cerebral plasticity by mirror therapy - evaluation of a new therapy approach for neurological rehabilitation

ISRCTN	ISRCTN31849226
DOI	https://doi.org/10.1186/ISRCTN31849226
Secondary identifying numbers	0315

Submission date: 27/02/2006
Registration date: 22/03/2006
Last edited: 26/06/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Christian Dohle
Scientific

MEDIAN Klinik Berlin
Department of Neurological Rehabilitation
Charite - University medicine Berlin
Campus Benjamin Franklin
Kladower Damm 223
Berlin
D-14089
Germany

Phone	+49 (0)30 36503 105/106
Email	dohle.berlin@median-kliniken.de

Study information

Study design	Randomised single-blinded placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Can be found at http://www.refonet.de/projekte/documents/Pat-Information-080924.pdf
Scientific title	Effect of mirror therapy early after stroke: a randomised, single-blinded, placebo-controlled trial
Study objectives	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(s)	Ethics Committee of the Physicians Chamber North Rhein (Arztekammer Nordrhein) (General Medical Council) approved on the 14th July 2004 (ref: 2004189)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2004
Completion date	31/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/07/2004
Date of final enrolment	31/08/2006

Locations

Countries of recruitment

Germany

Study participating centre

MEDIAN Klinik Berlin

Berlin
D-14089
Germany

Sponsor information

Refonet (Germany)
Industry

Burgweg 3
Bad Neuenahr-Ahrweiler
D-53445
Germany

Phone	+49 (0)264 190 620
Email	service@refonet.de
Website	http://www.refonet.de
"ROR"	https://ror.org/04yeh2x21

Funders

Funder type

Industry

Refonet (Germany) (ref: 3015)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No