Improving Hand Use in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Rehabilitating Extremity Use After Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01081275
• Other study ID #: RG 4221-A-2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 4, 2010
• Last updated: April 14, 2015
• Start date: February 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2015
• Source: National Multiple Sclerosis Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• CI Therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
• CAM treatments
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	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).	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	MSFC (Multiple Sclerosis Composite Measure)	The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance).	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	SARA (Scale for the Assessment and Rating of Ataxia)	The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	EDSS (Expanded Disability Status Scale)	The EDSS is the world-wide standard to evaluate physical capability in persons with MS.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	Fatigue Severity Scale (FSS)	The FSS evaluates the degree of overall fatigue experienced by the person with MS.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	Yes
Secondary	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.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	MSSS-88 (Multiple Sclerosis Spasticity Scale)	The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No
Secondary	Baecke Activity Questionnaire	The Baecke evaluates the impact of disease upon employment and leisure time activities.	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	No