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CompletedNCT00858910Updated Oct 25, 2013

Comparison of Embedded and Added Motor Imagery Training in Patients After Stroke

A Phase 2 interventional study of Motor imagery (MI) training and Control intervention in Stroke, sponsored by Reha Rheinfelden. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-25.

Sponsored by Reha Rheinfelden · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Motor imagery
  • Motor skill
  • Performance improvement
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    EG1: embedded MI

    Experimental group 1: Participants receive motor imagery (MI) training included in 45min physiotherapy, 3 times per week for 2 weeks.

    Other: Motor imagery (MI) training

  • Experimental
    EG2: added MI

    Experimental group 2: Participants receive a 15 minutes motor imagery (MI) training added to a 30 min physiotherapy session, 3 times a week for two weeks.

    Other: Motor imagery (MI) training

  • Placebo comparator
    CG

    Control group: Participants receive a 15 min control intervention added to their 30 min physiotherapy session, 3 times a week for two weeks.

    Other: Control intervention

Interventions

  • OtherMotor imagery (MI) training

    MI training encloses the internal rehearsal of a known motor skill without any overt motor output.

  • OtherControl 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.

05

What researchers measure

Primary outcomes

  1. Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."

    Time frame: 2 weeks

Secondary outcomes

  1. 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)

    Time frame: 2 weeks

  2. Motor impairment and independence measured with the extended Barthel index (EBI).

    Time frame: 2 weeks

  3. Balance measured with the Berg Balance Scale (BBS).

    Time frame: 2 weeks

  4. Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.

    Time frame: 2 weeks

  5. Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).

    Time frame: 2 weeks

06

Study locations

1 site
  • Rehabilitation centre: Reha Rheinfelden
    Rheinfelden, AG 4310, Switzerland
07

References and documents

Publications

  • 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. PubMed 18341687 ↗
  • 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. PubMed 22269834 ↗
  • 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. PubMed 19849835 ↗
08

Registry details

Key details

Study ID
NCT00858910
Lead sponsor
Reha Rheinfelden
Collaborators
Oxford Brookes University
First posted
Mar 10, 2009
Start date
Mar 2009
Primary completion
May 2010
Completion
May 2010
Last update
Oct 25, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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