Cerebrovascular AccidentPhase 3NORCIMTNCT00906477
Norwegian Constraint-Induced (CI) Therapy Multisite Trial
A Phase 3 study testing Modified CI therapy in people with Cerebrovascular Accident, run by University Hospital of North Norway at 5 sites in Norway.
Trial summary
The purpose of this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Modified CI therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesNorway
- Study dates
- Oct 2008to Jun 2013
- Phase
- Phase 3
- 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
- Stroke at more than 5 and less than 26 days ago.(Either first stroke or second stroke without detectable arm weakness after the first stroke).
- Modified ranking scale 0-2 before admission
- Persistent unilateral arm or hand paresis (Scandinavian Strokes scale (SSS) arm motor function 2-5 or SSS hand motor function 2-4)
- Able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position.
- Able to follow a two step command.
- Mini Mental State examination score of more than 20 (or more than 16 in combination with expressive aphasia)
Who cannot join
- Modified Rankin Scale > 4
- Unable to give informed consent
- Large hemispatial neglect (more than two cm on the Line Bisection Test)
- Not expected to survive one year due to other illnesses (eg cardiac, malignancy)
- Injury or condition in the affected upper extremity that limited use prior to the stroke.
- Other neurological condition affecting motor function
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Levanger Hospital
Levanger, N-7600
Oslo University hospital, Aker
Oslo, N-0514
Vestfold Klinikk Fysikalske medisin og rehabilitering, Kysthospital
Stavern, 3294
University Hospital of North Norway
Tromsø, Troms, N-9038
Trondheim University Hospital
Trondheim, Sør-Trøndelag, N-7006
About this study
Official title: Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.
The purpose of this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention group.
- Conditions
- Cerebrovascular Accident
- Being tested
- Modified CI therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified CI therapyProcedure or surgery
Also called Constraint induced movement therapy, Modified constraint induced movement therapy, CIMT, mCIMT
10 treatment days 3 hours a day: Shaping exercises 2 hours. Task practice 0,5 hours. Behavioral therapy (Transfer package) 0,5 hour. Encouragement to wear a restraining mitt on the least affected arm for all safe activities.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | Modified CI therapy starting between 7 and 28 days post stroke. Receives: Procedure: Modified CI therapy |
| Delayed intervention | Active comparator | Modified CI Therapy starting 6 months post stroke Receives: Procedure: Modified CI therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor function test
Measured: 6 months post inclusion
Secondary outcomes (7)
Arm use accelerometry
Measured: 6 months
Fugl Meyer Motor Assessment
Measured: 6 months
Nine hole peg test
Measured: 6 months
Wolf Motor Function Test
Measured: 12 months
Arm use accelerometry
Measured: 12 months
Fugl Meyer Motor Assessment
Measured: 12 months
Nine Hole Peg Test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startOct 2008
- Primary completionJan 2013
- Study completionJun 2013
Why it stopped: The study was extended for 2.5 years. A further extension could not be funded. When the study was halted in June 2012, 47 subjects were included.
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 Cerebrovascular AccidentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord
- Responsible party
- Sponsor
- Investigators
- Gyrd Thrane, Cand. San., Principal investigator, University Hospital of North NorwayAudny GM Anke, MD, PhD, Study chair, University Hospital of North NorwayBent Indredavik, MD, PhD, Principal investigator, Trondheim University HospitalTorunn Askim, PhD, Principal investigator, Norwegian University of Technology and ScienceRoland Stock, MSc, Principal investigator, Trondheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906477
- Sponsor's protocol ID
- Helse Nord SAT 544-06
- Acronym
- NORCIMT
- Status last verified
- Oct 2013
- First submitted
- 19 May 2009
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Thrane G, Askim T, Stock R, Indredavik B, Gjone R, Erichsen A, Anke A. Efficacy of Constraint-Induced Movement Therapy in Early Stroke Rehabilitation: A Randomized Controlled Multisite Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):517-25. doi: 10.1177/1545968314558599. Epub 2014 Nov 14.
PubMed 25398726
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.
- ClinicalTrials.gov ID
- NCT00906477
- Acronym / sponsor ID
- NORCIMT / Helse Nord SAT 544-06
- Conditions
- Cerebrovascular Accident
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was extended for 2.5 years. A further extension could not be funded. When the study was halted in June 2012, 47 subjects were included.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord
- Study start
- Oct 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 May 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 this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Procedure: Modified CI therapyModified CI therapy starting between 7 and 28 days post stroke. |
| Delayed intervention | Active comparator | Procedure: Modified CI therapyModified CI Therapy starting 6 months post stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke at more than 5 and less than 26 days ago.(Either first stroke or second stroke without detectable arm weakness after the first stroke).
- Modified ranking scale 0-2 before admission
- Persistent unilateral arm or hand paresis (Scandinavian Strokes scale (SSS) arm motor function 2-5 or SSS hand motor function 2-4)
- Able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position.
- Able to follow a two step command.
Key exclusion criteria (6 listed)
- Modified Rankin Scale > 4
- Unable to give informed consent
- Large hemispatial neglect (more than two cm on the Line Bisection Test)
- Not expected to survive one year due to other illnesses (eg cardiac, malignancy)
- Injury or condition in the affected upper extremity that limited use prior to the stroke.
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 |
|---|---|---|
| Modified CI therapyAlso: Constraint induced movement therapy, Modified constraint induced movement therapy, CIMT, mCIMT10 treatment days 3 hours a day: Shaping exercises 2 hours. Task practice 0,5 hours. Behavioral therapy (Transfer package) 0,5 hour. Encouragement to wear a restraining mitt on the least affected arm for all safe activities. | Procedure or surgery | Delayed intervention, Early intervention |
Primary outcome
Wolf Motor function test
Time frame: 6 months post inclusion
7 secondary outcomes
Arm use accelerometry
Time frame: 6 months
Fugl Meyer Motor Assessment
Time frame: 6 months
Nine hole peg test
Time frame: 6 months
Wolf Motor Function Test
Time frame: 12 months
Arm use accelerometry
Time frame: 12 months
Fugl Meyer Motor Assessment
Time frame: 12 months
Nine Hole Peg Test
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study was extended for 2.5 years. A further extension could not be funded. When the study was halted in June 2012, 47 subjects were included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Derived from this study: PubMed 25398726Thrane G, Askim T, Stock R, Indredavik B, Gjone R, Erichsen A, Anke A. Efficacy of Constraint-Induced Movement Therapy in Early Stroke Rehabilitation: A Randomized Controlled Multisite Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):517-25. doi: 10.1177/1545968314558599. Epub 2014 Nov 14.
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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.
Gyrd Thrane, Cand. San. principal investigator
University Hospital of North Norway
Audny GM Anke, MD, PhD study chair
University Hospital of North Norway
Bent Indredavik, MD, PhD principal investigator
Trondheim University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified CI therapy in people with Cerebrovascular Accident, run by University Hospital of North Norway at 5 sites in Norway.
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 6 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: stopped early, as of the sponsor's last update on 10 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 5 sites in Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: The study was extended for 2.5 years. A further extension could not be funded. When the study was halted in June 2012, 47 subjects were included.). Results are not available in the source record.
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?
Wolf Motor function test (time frame: 6 months post inclusion). 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 NCT00906477, 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 10 Oct 2013.