Clinical trial NCT00858910: Comparison of Embedded and Added Motor Imagery Training in Patients After Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Motor imagery
Motor skill
Performance improvement
Lead sponsor: Reha Rheinfelden
Sponsor class: OTHER
Collaborators: name: Oxford Brookes University
First posted: 2009-03-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The purpose of the study is to examine if patients in the embedded MI training into physiotherapy (EG1) need less time to perform the motor task than patients in the added MI training to physiotherapy (EG2).

A third groups serves a control group (CG) to investigate the effect of the intervention versus a group with a control intervention.

Additionally, semi-structured interviews before and after the intervention will give an insight in the patient's experience with motor imagery (MI), their expectations regarding the intervention and their opinions about MI after the intervention.

Eligibility criteria: 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

Primary outcomes:
measure: Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
timeFrame: 2 weeks
Secondary outcomes:
measure: 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)
timeFrame: 2 weeks
measure: Motor impairment and independence measured with the extended Barthel index (EBI).
timeFrame: 2 weeks
measure: Balance measured with the Berg Balance Scale (BBS).
timeFrame: 2 weeks
measure: Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.
timeFrame: 2 weeks
measure: Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Rehabilitation centre: Reha Rheinfelden
state: AG
Study officials:
References:
citation: 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.
citation: Schuster C, Butler J, Andrews B, Kischka U, Ettlin T. Comparison of embedded and added motor imagery training in patients after stroke: results of a randomised controlled pilot trial. Trials. 2012 Jan 23;13:11. doi: 10.1186/1745-6215-13-11.
citation: Schuster C, Butler J, Andrews B, Kischka U, Ettlin T. Comparison of embedded and added motor imagery training in patients after stroke: study protocol of a randomised controlled pilot trial using a mixed methods approach. Trials. 2009 Oct 22;10:97. doi: 10.1186/1745-6215-10-97.