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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00858910
Other study ID # 2008/077
Secondary ID
Status Completed
Phase Phase 2
First received March 9, 2009
Last updated October 24, 2013
Start date March 2009
Est. completion date May 2010

Study information

Verified date July 2010
Source Reha Rheinfelden
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Motor imagery (MI) training
MI training encloses the internal rehearsal of a known motor skill without any overt motor output.
Control intervention
The control intervention encloses relaxation and breathing exercises, and information about: the disease (stroke), therapy options, self-help groups and their offers for support, helping aids for independent living at home.

Locations

Country Name City State
Switzerland Rehabilitation centre: Reha Rheinfelden Rheinfelden AG

Sponsors (2)

Lead Sponsor Collaborator
Reha Rheinfelden Oxford Brookes University

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

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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