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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Motor imagery (MI) training
Control intervention
Sponsored by
Reha Rheinfelden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Motor imagery, Motor skill, Performance improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation centre: Reha Rheinfelden

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EG1: embedded MI

EG2: added MI

CG

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Motor impairment and independence measured with the extended Barthel index (EBI).
Balance measured with the Berg Balance Scale (BBS).
Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.
Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).

Full Information

First Posted
March 9, 2009
Last Updated
October 24, 2013
Sponsor
Reha Rheinfelden
Collaborators
Oxford Brookes University
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1. Study Identification

Unique Protocol Identification Number
NCT00858910
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Reha Rheinfelden
Collaborators
Oxford Brookes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Motor imagery, Motor skill, Performance improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EG1: embedded MI
Arm Type
Experimental
Arm Description
Experimental group 1: Participants receive motor imagery (MI) training included in 45min physiotherapy, 3 times per week for 2 weeks.
Arm Title
EG2: added MI
Arm Type
Experimental
Arm Description
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.
Arm Title
CG
Arm Type
Placebo Comparator
Arm Description
Control group: Participants receive a 15 min control intervention added to their 30 min physiotherapy session, 3 times a week for two weeks.
Intervention Type
Other
Intervention Name(s)
Motor imagery (MI) training
Intervention Description
MI training encloses the internal rehearsal of a known motor skill without any overt motor output.
Intervention Type
Other
Intervention Name(s)
Control intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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
Title
Motor impairment and independence measured with the extended Barthel index (EBI).
Time Frame
2 weeks
Title
Balance measured with the Berg Balance Scale (BBS).
Time Frame
2 weeks
Title
Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.
Time Frame
2 weeks
Title
Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rehabilitation centre: Reha Rheinfelden
City
Rheinfelden
State/Province
AG
ZIP/Postal Code
4310
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18341687
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.
Results Reference
background
PubMed Identifier
22269834
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.
Results Reference
derived
PubMed Identifier
19849835
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.
Results Reference
derived

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

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