StrokePhase 2NCT00681434
Bilateral Training Versus Unilateral Training in Stroke
A Phase 2 study testing bilateral upper extremity training and Unilateral upper extremity training in people with Stroke and Hemiparesis, run by University of Illinois at Chicago.
Trial summary
This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- bilateral upper extremity training and Unilateral upper extremity training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Aug 2007
- 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
- cortical or subcortical stroke
- chronic condition (at least six months prior)
- ability to follow 2-step commands
- ability to give consent
Who cannot join
- lesion in brain stem or cerebellum
- visual field cut
- neglect
- uncontrolled hypertension
- angina
- COPD
About this study
Official title: Bilateral Training for Upper Extremity Hemiparesis in Stroke
This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.
Read the detailed description
Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.
This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.
- Conditions
- Stroke, Hemiparesis
- Being tested
- bilateral upper extremity training, Unilateral upper extremity training
- Keywords
- stroke, upper extremity, hemiparesis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral upper extremity trainingBehavioural
Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
Unilateral upper extremity trainingBehavioural
Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | bilateral training Receives: Behavioral: bilateral upper extremity training |
| 2 | Active comparator | Unilateral training Receives: Behavioral: Unilateral upper extremity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Assessment Scale
Measured: pre and post (week one and week 8)
Motor Status Scale
Measured: pre and post, Week 0 and Week eight
Secondary outcomes (1)
Reaching Performance Scale
Measured: pre and post training (Week 0 and week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2005
- Primary completionAug 2007
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Investigators
- Mary E Stoykov, PhD, Principal investigator, University of Illinois at Chicago Department of Kinesiology and NutritionDaniel M Corcos, PhD, Study chair, University of Illinois at Chicago Department of Kinesiology and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681434
- Sponsor's protocol ID
- 2006-0234
- Status last verified
- Aug 2014
- First submitted
- 19 May 2008
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.
PubMed 19531608
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Training for Upper Extremity Hemiparesis in Stroke
- ClinicalTrials.gov ID
- NCT00681434
- Acronym / sponsor ID
- 2006-0234
- Conditions
- Stroke, Hemiparesis
- Keywords
- stroke, upper extremity, hemiparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- May 2005
- Primary completion
- Aug 2007 (actual)
- First posted
- 21 May 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.
This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.
Detailed description
Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.
This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.
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: bilateral upper extremity trainingbilateral training |
| 2 | Active comparator | Behavioral: Unilateral upper extremity trainingUnilateral training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cortical or subcortical stroke
- chronic condition (at least six months prior)
- ability to follow 2-step commands
- ability to give consent
Key exclusion criteria (6 listed)
- lesion in brain stem or cerebellum
- visual field cut
- neglect
- uncontrolled hypertension
- angina
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 |
|---|---|---|
| bilateral upper extremity trainingBilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks. | Behavioural | 1 |
| Unilateral upper extremity trainingUnilateral upper extremity training for proximal extremity for three hours a week for eight weeks. | Behavioural | 2 |
Primary outcome
Motor Assessment Scale
Time frame: pre and post (week one and week 8)
Motor Status Scale
Time frame: pre and post, Week 0 and Week eight
1 secondary outcome
Reaching Performance Scale
Time frame: pre and post training (Week 0 and week 8)
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 Aug 2014.
- Results publication: PubMed 19531608Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.
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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.
Mary E Stoykov, PhD principal investigator
University of Illinois at Chicago Department of Kinesiology and Nutrition
Daniel M Corcos, PhD study chair
University of Illinois at Chicago Department of Kinesiology and Nutrition
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bilateral upper extremity training and Unilateral upper extremity training in people with Stroke and Hemiparesis, run by University of Illinois at Chicago.
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 4 inclusion and 6 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 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Motor Assessment Scale (time frame: pre and post (week one and week 8)). The study lists 2 primary outcomes in all. 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 NCT00681434, 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 Aug 2014.