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

October 24, 2013 updated by: Reha Rheinfelden

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • AG
      • Rheinfelden, AG, Switzerland, 4310
        • Rehabilitation centre: Reha Rheinfelden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
MI training encloses the internal rehearsal of a known motor skill without any overt motor output.
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
MI training encloses the internal rehearsal of a known motor skill without any overt motor output.
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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 weeks
Motor impairment and independence measured with the extended Barthel index (EBI).
Time Frame: 2 weeks
2 weeks
Balance measured with the Berg Balance Scale (BBS).
Time Frame: 2 weeks
2 weeks
Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.
Time Frame: 2 weeks
2 weeks
Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reha Rheinfelden

Collaborators

Oxford Brookes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (ESTIMATE)

March 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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