Multiple SclerosisPhase 1NCT00695084
Constraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)
A Phase 1 study testing Constraint-Induced Movement Therapy in people with Multiple Sclerosis, run by National Multiple Sclerosis Society at 1 site in United States.
Trial summary
This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis may benefit from Constraint-Induced Movement Therapy. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Constraint-Induced Movement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Apr 2008
- Phase
- Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic upper extremity motor deficit due to multiple sclerosis
Who cannot join
- Relapse within 3 months of planned enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Constraint-Induced Movement Therapy Trial for Progressive Multiple Sclerosis
This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis may benefit from Constraint-Induced Movement Therapy.
Read the detailed description
Constraint-Induced Movement Therapy was developed to treat stroke hemiparesis. Due to the similarity between multiple sclerosis and stroke in terms of chronic motor deficit, this trial will attempt to determine whether multiple sclerosis may benefit similarly from Constraint-Induced Movement Therapy.
- Conditions
- Multiple Sclerosis
- Being tested
- Constraint-Induced Movement Therapy
- Keywords
- multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement TherapyBehavioural
Also called CI Therapy
Intensive practice with the hemiparetic arm for 30 contact hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with Constraint-Induced Movement Therapy Receives: Behavioral: Constraint-Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on the Motor Activity Log
Measured: One year
Secondary outcomes (1)
Improvement on the Wolf Motor Function Test
Measured: Pre to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Multiple Sclerosis Society
- Sponsor type
- University, hospital or other
- Investigators
- Victor W Mark, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695084
- Sponsor's protocol ID
- CIMSTrial
- Other IDs
- PP1395
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-Induced Movement Therapy Trial for Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00695084
- Acronym / sponsor ID
- CIMSTrial
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Multiple Sclerosis SocietyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Jun 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 trial will evaluate whether progressive multiple sclerosis associated with hemiparesis may benefit from Constraint-Induced Movement Therapy.
Detailed description
Constraint-Induced Movement Therapy was developed to treat stroke hemiparesis. Due to the similarity between multiple sclerosis and stroke in terms of chronic motor deficit, this trial will attempt to determine whether multiple sclerosis may benefit similarly from Constraint-Induced Movement Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Constraint-Induced Movement TherapyTreatment with Constraint-Induced Movement Therapy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic upper extremity motor deficit due to multiple sclerosis
Key exclusion criteria (1 listed)
- Relapse within 3 months of planned enrollment.
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 |
|---|---|---|
| Constraint-Induced Movement TherapyAlso: CI TherapyIntensive practice with the hemiparetic arm for 30 contact hours | Behavioural | 1 |
Primary outcome
Improvement on the Motor Activity Log
Time frame: One year
1 secondary outcome
Improvement on the Wolf Motor Function Test
Time frame: Pre to post-treatment
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 11 Jun 2008.
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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.
Victor W Mark, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Constraint-Induced Movement Therapy in people with Multiple Sclerosis, run by National Multiple Sclerosis Society at 1 site in United States.
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 1 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 11 Jun 2008. 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 States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Improvement on the Motor Activity Log (time frame: One year). 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 11 Jun 2008.