Multiple SclerosisPhase 2NCT01081275

Improving Hand Use in Multiple Sclerosis

A Phase 2 study testing CI Therapy and CAM treatments in people with Multiple Sclerosis, run by National Multiple Sclerosis Society at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation… 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?: CI Therapy and CAM treatments
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Feb 2010to Mar 2016
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 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS)
reduced use of one of the hands because of MS
ability to pick up and release a small object with the more-affected hand when requested
can travel to the treatment program at the University of Alabama at Birmingham (UAB)
can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day
can undergo MRI scan
any kind of medication used for MS is allowed except spasticity medicine

Who cannot join

disease relapse in the past 3 months
pregnancy
marked pain with arm movement
severe uncontrolled medical illness
simultaneous treatment with another form of physical therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35249

Other trials in United States

About this study

Official title: Rehabilitating Extremity Use After Multiple Sclerosis

Read the detailed description

Multiple Sclerosis (MS) frequently causes reduced use of one of the hands, and as a result, much of daily living activities are conducted only by the other hand, leaving the person effective one-handed. Nonetheless, reduced hand use can be improved for extended amounts of time with specific forms of physical therapy, as long as persons with MS have the ability to perform the training tasks.

This study will randomize persons with MS who have relatively reduced use of one of the hands to either CI therapy or CAM treatments. Treatment in either program will be for 2 consecutive weeks, 3.5 hours per day (Monday-Friday), under the direct supervision of a specially trained therapist. Before starting, participants will also undergo comprehensive medical and physical exam screening and brain MRI scan. The same evaluations will be performed after treatment to learn whether any of these have changed as a result of treatment.

Conditions: Multiple Sclerosis
Being tested: CI Therapy, CAM treatments
Keywords: Multiple Sclerosis, MS, CI Therapy, CIMT, Constraint-Induced Movement Therapy, Complementary and Alternative Medicine, CAM, Physical Therapy, Occupational Therapy, Relaxation, Exercise, Massage, Yoga, Pool Therapy, Aquatherapy, Aquatic Therapy
Medical subject headings: Multiple Sclerosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CI TherapyBehavioural
Also called Constraint-Induced Movement therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
CAM treatmentsBehavioural
Also called Complementary and Alternative Medicine
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Study groups in NCT01081275
Study group	Role	What they receive
CI Therapy	Active comparator	CI therapy involves repetitive practice with the more-affected hand on typical daily living activities (such as stacking objects, pouring, moving objects) for 3.5 hours per day, along with physical restraint of the better hand to keep it from assisting, and home practice exercises. Receives: Behavioral: CI Therapy
CAM treatments	Active comparator	CAM treatments are holistic physical treatments designed to work on the entire body to improve quality of life and overall health. This study will use yoga, relaxation exercises, aquatherapy (pool therapy), and massage. Receives: Behavioral: CAM treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

Motor Activity Log (MAL)
The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Secondary outcomes (8)

Wolf Motor Function Test (WMFT)
The WMFT evaluates how fast the more-affected hand can complete several activities that resemble those in the home (such as bringing a can to the lips).
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSFC (Multiple Sclerosis Composite Measure)
The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance).
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
SARA (Scale for the Assessment and Rating of Ataxia)
The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
EDSS (Expanded Disability Status Scale)
The EDSS is the world-wide standard to evaluate physical capability in persons with MS.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Fatigue Severity Scale (FSS)
The FSS evaluates the degree of overall fatigue experienced by the person with MS.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSIS-29 (Multiple Sclerosis Impact Scale)
The MSIS-29 is a questionnaire that evaluates the impact of MS on daily living activities and quality of life.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSSS-88 (Multiple Sclerosis Spasticity Scale)
The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Baecke Activity Questionnaire
The Baecke evaluates the impact of disease upon employment and leisure time activities.
Measured: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Mar 2016

First posted5 Mar 2010 (estimated)
Study startFeb 2010
Primary completionFeb 2016 (estimated)
Study completionMar 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01081275
Sponsor's protocol ID: RG 4221-A-2
Status last verified: Apr 2015
First submitted: 4 Mar 2010
Last updated: 15 Apr 2015
Results posted: No
Data monitoring committee: Yes

Publications

Mark VW, Taub E, Bashir K, Uswatte G, Delgado A, Bowman MH, Bryson CC, McKay S, Cutter GR. Constraint-Induced Movement therapy can improve hemiparetic progressive multiple sclerosis. Preliminary findings. Mult Scler. 2008 Aug;14(7):992-4. doi: 10.1177/1352458508090223. Epub 2008 Jun 23.
PubMed 18573826
Barghi A, Allendorfer JB, Taub E, Womble B, Hicks JM, Uswatte G, Szaflarski JP, Mark VW. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 2: Effect on White Matter Integrity. Neurorehabil Neural Repair. 2018 Mar;32(3):233-241. doi: 10.1177/1545968317753073.
PubMed 29668401
Mark VW, Taub E, Uswatte G, Morris DM, Cutter GR, Adams TL, Bowman MH, McKay S. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. Neurorehabil Neural Repair. 2018 Mar;32(3):223-232. doi: 10.1177/1545968318761050.
PubMed 29668399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rehabilitating Extremity Use After Multiple Sclerosis
ClinicalTrials.gov ID: NCT01081275
Acronym / sponsor ID: RG 4221-A-2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, MS, CI Therapy, CIMT, Constraint-Induced Movement Therapy, Complementary and Alternative Medicine, CAM, Physical Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 66 participants (estimated)
Lead sponsor: National Multiple Sclerosis SocietyUniversity, hospital or other
Study start: Feb 2010
Primary completion: Feb 2016 (estimated)
Study completion: Mar 2016 (estimated)
First posted: 5 Mar 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CI Therapy	Active comparator	Behavioral: CI TherapyCI therapy involves repetitive practice with the more-affected hand on typical daily living activities (such as stacking objects, pouring, moving objects) for 3.5 hours per day, along with physical restraint of the better hand to keep it from assisting, and home practice exercises.
CAM treatments	Active comparator	Behavioral: CAM treatmentsCAM treatments are holistic physical treatments designed to work on the entire body to improve quality of life and overall health. This study will use yoga, relaxation exercises, aquatherapy (pool therapy), and massage.

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS)
reduced use of one of the hands because of MS
ability to pick up and release a small object with the more-affected hand when requested
can travel to the treatment program at the University of Alabama at Birmingham (UAB)
can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day

Key exclusion criteria (5 listed)

disease relapse in the past 3 months
pregnancy
marked pain with arm movement
severe uncontrolled medical illness
simultaneous treatment with another form of physical therapy

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
CI TherapyAlso: Constraint-Induced Movement therapyCI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.	Behavioural	CI Therapy
CAM treatmentsAlso: Complementary and Alternative MedicineCAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.	Behavioural	CAM treatments

Primary outcome

Motor Activity Log (MAL)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.

8 secondary outcomes

Wolf Motor Function Test (WMFT)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSFC (Multiple Sclerosis Composite Measure)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
SARA (Scale for the Assessment and Rating of Ataxia)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
EDSS (Expanded Disability Status Scale)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Fatigue Severity Scale (FSS)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSIS-29 (Multiple Sclerosis Impact Scale)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSSS-88 (Multiple Sclerosis Spasticity Scale)
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Baecke Activity Questionnaire
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
Background: PubMed 18573826Mark VW, Taub E, Bashir K, Uswatte G, Delgado A, Bowman MH, Bryson CC, McKay S, Cutter GR. Constraint-Induced Movement therapy can improve hemiparetic progressive multiple sclerosis. Preliminary findings. Mult Scler. 2008 Aug;14(7):992-4. doi: 10.1177/1352458508090223. Epub 2008 Jun 23.
Derived from this study: PubMed 29668401Barghi A, Allendorfer JB, Taub E, Womble B, Hicks JM, Uswatte G, Szaflarski JP, Mark VW. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 2: Effect on White Matter Integrity. Neurorehabil Neural Repair. 2018 Mar;32(3):233-241. doi: 10.1177/1545968317753073.
Derived from this study: PubMed 29668399Mark VW, Taub E, Uswatte G, Morris DM, Cutter GR, Adams TL, Bowman MH, McKay S. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. Neurorehabil Neural Repair. 2018 Mar;32(3):223-232. doi: 10.1177/1545968318761050.

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RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
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Active, not recruitingObservational study
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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 2 study testing CI Therapy and CAM treatments 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Apr 2015. 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 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?

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 (MAL) (time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.). 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 NCT01081275, which also lists 3 linked publications.

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 15 Apr 2015.