StrokePhase 2NCT00618085
Motor Imagery Practice in Neurological Rehabilitation
A Phase 2 study testing Motor imagery practice and Standard physiotherapy and occupational therapy in people with Stroke and Brain Injury, run by Nuffield Orthopaedic Centre NHS Trust at 1 site in United Kingdom.
Trial summary
Motor imagery is a technique widely used in learning skills. Its effectiveness has been proven in various sports and in musicians. A recent review (Braun et al. 2006) suggested that this technique may also be effective in rehabilitation of patients with neurological disease or damage, but that further research was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brain Injury, Multiple Sclerosis
- What is being tested?
- Motor imagery practice and Standard physiotherapy and occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Apr 2009
- 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
- Participating in a rehabilitation program for problems arising secondary to disease or damage affecting the central nervous system (usually stroke, brain injury, multiple sclerosis)
- Over 18 years of age
- Have sufficient language and memory skills to undertake the intervention (i.e. score positive on the first three items of the Sheffield screening test)
Who cannot join
- Any co-morbidity that would interfere with the ability to perform imagery as judged by the clinician or from the medical notes (e.g., schizophrenia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrated Motor Imagery Program in Rehabilitation - a RCT
Motor imagery is a technique widely used in learning skills. Its effectiveness has been proven in various sports and in musicians. A recent review (Braun et al. 2006) suggested that this technique may also be effective in rehabilitation of patients with neurological disease or damage, but that further research was needed.
The main purpose of this research is to discover whether motor imagery practice is beneficial in the rehabilitation of skills in patients who have some disability due to neurological disease or damage. The principal research question is: are physiotherapy and occupational therapy given incorporating motor imagery more effective than standard care (i.e., the same therapies but without integrated motor imagery) in re-training task specific performance for patients with neurological disease or damage?
- Conditions
- Stroke, Brain Injury, Multiple Sclerosis
- Being tested
- Motor imagery practice, Standard physiotherapy and occupational therapy
- Medical subject headings
- Stroke, Brain Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery practiceBehavioural
During motor imagery practice a person imagines performing a skill or movement with all its sensory consequences without actually moving. In this study the therapists follow a motor imagery guideline designed for rehabilitation of skills and movement performance in subjects with neurological disease or damage. The guideline offers therapists structure and a strategy to deliver subject-specific imagery. The guideline is based on three major frameworks, namely; principles of motor learning, phased process of human movement and a training guide for sports coaches and performers from the National Coaching Foundation.
Standard physiotherapy and occupational therapyOther
Patients with neurological disease or damage will receive standard physiotherapy and occupational therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients will receive the occupational therapy and physiotherapy normally given in their setting.
In addition; the experimental group will receive 2 instruction DVD's introducing them to motor imagery practice, taking 35 minutes in total. The research therapist will also attend the first session with the physiotherapist and with the occupational therapist to help incorporate motor imagery within the therapy. Thereafter the therapist will help the patient use motor imagery as part of their normal treatment. The total amount spent on motor imagery during therapy sessions will be 6.5 hours in 6 weeks. Receives: Behavioral: Motor imagery practice |
| 2 | Active comparator | All patients will receive the occupational therapy and physiotherapy normally given in their setting.
In addition; the control group will receive 2 DVDs for 35 minutes in total. These will show background information on their condition, explaining the importance of practice of activities, and on the principles of motor learning and phased movement which underlie most therapy.The research therapist will also attend the first session with the physiotherapist and with the occupational therapist to control for attention. The total amount the physiotherapist and occupational therapist spend with the patients should be the same in both groups. Receives: Other: Standard physiotherapy and occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling
Measured: After 6 and 12 weeks
Secondary outcomes (3)
Motor imagery questionnaire
Measured: Baseline, 6 weeks, 12 weeks
Timed up and go
Measured: Baseline, 6 weeks, 12 weeks
Action research arm test
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuffield Orthopaedic Centre NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Investigators
- Thamar J Bovend'Eerdt, MSc, Principal investigator, Oxford Centre for EnablementDerick T Wade, MD, Study director, Oxford Centre for Enablement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618085
- Sponsor's protocol ID
- 07/H0605/84NOC
- Other IDs
- 07/H0605/84
- Status last verified
- May 2009
- First submitted
- 5 Feb 2008
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Braun SM, Beurskens AJ, Borm PJ, Schack T, Wade DT. The effects of mental practice in stroke rehabilitation: a systematic review. Arch Phys Med Rehabil. 2006 Jun;87(6):842-52. doi: 10.1016/j.apmr.2006.02.034.
PubMed 16731221
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Motor Imagery Program in Rehabilitation - a RCT
- ClinicalTrials.gov ID
- NCT00618085
- Acronym / sponsor ID
- 07/H0605/84NOC
- Conditions
- Stroke, Brain Injury, Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nuffield Orthopaedic Centre NHS TrustUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Feb 2008 (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.
Motor imagery is a technique widely used in learning skills. Its effectiveness has been proven in various sports and in musicians. A recent review (Braun et al. 2006) suggested that this technique may also be effective in rehabilitation of patients with neurological disease or damage, but that further research was needed.
The main purpose of this research is to discover whether motor imagery practice is beneficial in the rehabilitation of skills in patients who have some disability due to neurological disease or damage. The principal research question is: are physiotherapy and occupational therapy given incorporating motor imagery more effective than standard care (i.e., the same therapies but without integrated motor imagery) in re-training task specific performance for patients with neurological disease or damage?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motor imagery practiceAll patients will receive the occupational therapy and physiotherapy normally given in their setting. In addition; the experimental group will receive 2 instruction DVD's introducing them to motor imagery practice, taking 35 minutes in total. The research therapist will also attend the first session with the physiotherapist and with the occupational therapist to help incorporate motor imagery within the therapy. Thereafter the therapist will help the patient use motor imagery as part of their normal treatment. The total amount spent on motor imagery during therapy sessions will be 6.5 hours in 6 weeks. |
| 2 | Active comparator | Other: Standard physiotherapy and occupational therapyAll patients will receive the occupational therapy and physiotherapy normally given in their setting. In addition; the control group will receive 2 DVDs for 35 minutes in total. These will show background information on their condition, explaining the importance of practice of activities, and on the principles of motor learning and phased movement which underlie most therapy.The research therapist will also attend the first session with the physiotherapist and with the occupational therapist to control for attention. The total amount the physiotherapist and occupational therapist spend with the patients should be the same in both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participating in a rehabilitation program for problems arising secondary to disease or damage affecting the central nervous system (usually stroke, brain injury, multiple sclerosis)
- Over 18 years of age
- Have sufficient language and memory skills to undertake the intervention (i.e. score positive on the first three items of the Sheffield screening test)
Key exclusion criteria (1 listed)
- Any co-morbidity that would interfere with the ability to perform imagery as judged by the clinician or from the medical notes (e.g., schizophrenia)
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 practiceDuring motor imagery practice a person imagines performing a skill or movement with all its sensory consequences without actually moving. In this study the therapists follow a motor imagery guideline designed for rehabilitation of skills and movement performance in subjects with neurological disease or damage. The guideline offers therapists structure and a strategy to deliver subject-specific imagery. The guideline is based on three major frameworks, namely; principles of motor learning, phased process of human movement and a training guide for sports coaches and performers from the National Coaching Foundation. | Behavioural | 1 |
| Standard physiotherapy and occupational therapyPatients with neurological disease or damage will receive standard physiotherapy and occupational therapy. | Other | 2 |
Primary outcome
Goal Attainment Scaling
Time frame: After 6 and 12 weeks
3 secondary outcomes
Motor imagery questionnaire
Time frame: Baseline, 6 weeks, 12 weeks
Timed up and go
Time frame: Baseline, 6 weeks, 12 weeks
Action research arm test
Time frame: Baseline, 6 weeks, 12 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 4 May 2009.
- Background: PubMed 16731221Braun SM, Beurskens AJ, Borm PJ, Schack T, Wade DT. The effects of mental practice in stroke rehabilitation: a systematic review. Arch Phys Med Rehabil. 2006 Jun;87(6):842-52. doi: 10.1016/j.apmr.2006.02.034.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Thamar J Bovend'Eerdt, MSc principal investigator
Oxford Centre for Enablement
Derick T Wade, MD study director
Oxford Centre for Enablement
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 practice and Standard physiotherapy and occupational therapy in people with Stroke and Brain Injury, run by Nuffield Orthopaedic Centre NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 1 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 4 May 2009. 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 United Kingdom. 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. 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?
Goal Attainment Scaling (time frame: After 6 and 12 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 NCT00618085, which also lists 1 linked publication.
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 4 May 2009.