StrokePhase 2NCT00858910
Comparison of Embedded and Added Motor Imagery Training in Patients After Stroke
A Phase 2 study testing Motor imagery (MI) training in people with Stroke, run by Reha Rheinfelden at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Motor imagery (MI) training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehabilitation centre: Reha Rheinfelden
Rheinfelden, Canton of Aargau, 4310
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Motor imagery (MI) training, Control intervention
- Keywords
- Motor imagery, Motor skill, Performance improvement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery (MI) trainingOther
MI training encloses the internal rehearsal of a known motor skill without any overt motor output.
Control interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EG1: embedded MI | Experimental | Experimental group 1:
Participants receive motor imagery (MI) training included in 45min physiotherapy, 3 times per week for 2 weeks. Receives: Other: Motor imagery (MI) training |
| EG2: added MI | Experimental | 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. Receives: Other: Motor imagery (MI) training |
| CG | Placebo comparator | Control group:
Participants receive a 15 min control intervention added to their 30 min physiotherapy session, 3 times a week for two weeks. Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
Measured: 2 weeks
Secondary outcomes (5)
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)
Measured: 2 weeks
Motor impairment and independence measured with the extended Barthel index (EBI).
Measured: 2 weeks
Balance measured with the Berg Balance Scale (BBS).
Measured: 2 weeks
Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.
Measured: 2 weeks
Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reha Rheinfelden
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858910
- Sponsor's protocol ID
- 2008/077
- Status last verified
- Jul 2010
- First submitted
- 9 Mar 2009
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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 18341687Schuster 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 22269834Schuster 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00858910
- Acronym / sponsor ID
- 2008/077
- Conditions
- Stroke
- Keywords
- Motor imagery, Motor skill, Performance improvement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Reha RheinfeldenUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EG1: embedded MI | Experimental | Other: Motor imagery (MI) trainingExperimental group 1: Participants receive motor imagery (MI) training included in 45min physiotherapy, 3 times per week for 2 weeks. |
| EG2: added MI | Experimental | Other: Motor imagery (MI) trainingExperimental 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. |
| CG | Placebo comparator | Other: Control interventionControl group: Participants receive a 15 min control intervention added to their 30 min physiotherapy session, 3 times a week for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor imagery (MI) trainingMI training encloses the internal rehearsal of a known motor skill without any overt motor output. | Other | EG1: embedded MI, EG2: added MI |
| Control interventionThe 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. | Other | CG |
Primary outcome
Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
Time frame: 2 weeks
5 secondary outcomes
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
Motor impairment and independence measured with the extended Barthel index (EBI).
Time frame: 2 weeks
Balance measured with the Berg Balance Scale (BBS).
Time frame: 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
Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
- Background: PubMed 18341687Zimmermann-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.
- Derived from this study: PubMed 22269834Schuster 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.
- Derived from this study: PubMed 19849835Schuster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motor imagery (MI) training in people with Stroke, run by Reha Rheinfelden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again." (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858910, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.