Stroke Clinical Trial
Official title:
Comparison of Embedded and Added Motor Imagery Training to Improve a Motor Skill in Patients After Stroke: a Pilot Randomised Controlled Trial Using a Mixed Methods Approach
| Verified date | July 2010 |
| Source | Reha Rheinfelden |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
The purpose of the study is to examine if patients in the embedded motor imagery (MI) training group (EG1) need less time to perform the motor task than patients in the added MI training group (EG2).
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | May 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients after a first-ever ischemic or hemorrhagic stroke - Outpatients or leaving inpatients 3 months after stroke - Ability to stand with or without a cane for at least 30 sec on a normal hard floor - Ability to walk for 20 metres with or without a cane or an orthosis - MMSE with at least 20 points - Age older than 18 years - Signed written informed consent Exclusion Criteria: - Joint replacements (knee, hip, shoulder) - Limiting pain in the upper or lower body - Limiting range of motion (ROM) in the hip, knee, ankle joint or toes - Body weight more than 90 kilograms - Compromised mental capacity to give written informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Rehabilitation centre: Reha Rheinfelden | Rheinfelden | AG |
| Lead Sponsor | Collaborator |
|---|---|
| Reha Rheinfelden | Oxford Brookes University |
Switzerland,
Zimmermann-Schlatter A, Schuster C, Puhan MA, Siekierka E, Steurer J. Efficacy of motor imagery in post-stroke rehabilitation: a systematic review. J Neuroeng Rehabil. 2008 Mar 14;5:8. doi: 10.1186/1743-0003-5-8. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again." | 2 weeks | No | |
| Secondary | Further outcome measures: - Help needed to perform the task, scored on a 7-item scale (1 total help, 7 completely independent) - Stage of motor task (one out of 13 possible stages) | 2 weeks | No | |
| Secondary | Motor impairment and independence measured with the extended Barthel index (EBI). | 2 weeks | No | |
| Secondary | Balance measured with the Berg Balance Scale (BBS). | 2 weeks | No | |
| Secondary | Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software. | 2 weeks | No | |
| Secondary | Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale). | 2 weeks | No |
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