StrokePhase 3LICITENCT00839670
Light Constraint Induced Therapy Experiment
A Phase 3 study testing Light constraint induced therapy and Standard constraint induced therapy in people with Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Light constraint induced therapy and Standard constraint induced therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jun 2011
- 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
- Age > 18 years
- First ischemic or hemorrhagic stroke between 2 and 12 months
- at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
- adequate balance while wearing the restraint
Who cannot join
- Major cognitive impairment
- Prior stroke
- Excessive fatigability
- Severe aphasia
- MAL score ≥ 2,5
- Specific exclusion criteria for fMRI ancillary study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
Paris, Paris Cedex 18, 75877
About this study
Official title: Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.
Read the detailed description
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.
The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).
Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.
- Conditions
- Stroke
- Being tested
- Light constraint induced therapy, Standard constraint induced therapy
- Keywords
- 1- Constraint induced therapy, 2- Stroke, 3- Upper limb, 4- Rehabilitation, 5- Motor training, 1- First time clinical ischemic or hemorrhagic stroke, 2- At least 10° of active wrist extension, 3- At least 10° of thumb abduction/ extension, 4- At least 10° of extension in at least 2 additional digits, 3- Adequate balance while wearing the restraint.
- Medical subject headings
- Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light constraint induced therapyOther
Also called Modified constraint induced therapy
90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
Standard constraint induced therapyOther
Also called Constraint induced therapy
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Modified Therapy | Active comparator | Not described Receives: Other: Light constraint induced therapy |
| Standard Therapy | Active comparator | Not described Receives: Other: Standard constraint induced therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor activity log scale
Measured: 10 days before inclusion, 10 days and 3 months after treatment achievement
Secondary outcomes (1)
Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
Measured: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionJun 2011
Why it stopped: departure of the investigator coordinator into other country
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier SIMON, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839670
- Sponsor's protocol ID
- P070161
- Acronym
- LICITE
- Status last verified
- Feb 2009
- First submitted
- 6 Feb 2009
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00839670
- Acronym / sponsor ID
- LICITE / P070161
- Conditions
- Stroke
- Keywords
- 1- Constraint induced therapy, 2- Stroke, 3- Upper limb, 4- Rehabilitation, 5- Motor training, 1- First time clinical ischemic or hemorrhagic stroke, 2- At least 10° of active wrist extension, 3- At least 10° of thumb abduction/ extension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of the investigator coordinator into other country
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Feb 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 trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.
Detailed description
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.
The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).
Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Therapy | Active comparator | Other: Light constraint induced therapy |
| Standard Therapy | Active comparator | Other: Standard constraint induced therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- First ischemic or hemorrhagic stroke between 2 and 12 months
- at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
- adequate balance while wearing the restraint
Key exclusion criteria (6 listed)
- Major cognitive impairment
- Prior stroke
- Excessive fatigability
- Severe aphasia
- MAL score ≥ 2,5
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 |
|---|---|---|
| Light constraint induced therapyAlso: Modified constraint induced therapy90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks. | Other | Modified Therapy |
| Standard constraint induced therapyAlso: Constraint induced therapy360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks | Other | Standard Therapy |
Primary outcome
Motor activity log scale
Time frame: 10 days before inclusion, 10 days and 3 months after treatment achievement
1 secondary outcome
Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
Time frame: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
Results and safety
The study was stopped early (reason given: departure of the investigator coordinator into other country). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
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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.
Olivier SIMON, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Light constraint induced therapy and Standard constraint induced therapy in people with Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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: stopped early, as of the sponsor's last update on 10 Jan 2012. 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 France. 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: departure of the investigator coordinator into other country). 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?
Motor activity log scale (time frame: 10 days before inclusion, 10 days and 3 months after treatment achievement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2012.