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 |
| Protocol serial number | 0315 |
| Sponsor | Refonet (Germany) |
| Funder | Refonet (Germany) (ref: 3015) |
- 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
Contact information
Dr Christian Dohle
Scientific
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 |
|---|---|
| dohle.berlin@median-kliniken.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blinded placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
Fugl Meyer (FM) score after six weeks of intervention |
| Key secondary outcome measure(s) |
1. Action research arm test (ARAT) score after six weeks of intervention |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
D-14089
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
