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Improving Hand Use in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CI Therapy
CAM treatments
Sponsored by
National Multiple Sclerosis Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring 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

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CI Therapy

CAM treatments

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
MSFC (Multiple Sclerosis Composite Measure)
The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance).
SARA (Scale for the Assessment and Rating of Ataxia)
The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.
EDSS (Expanded Disability Status Scale)
The EDSS is the world-wide standard to evaluate physical capability in persons with MS.
Fatigue Severity Scale (FSS)
The FSS evaluates the degree of overall fatigue experienced by the person with MS.
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.
MSSS-88 (Multiple Sclerosis Spasticity Scale)
The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.
Baecke Activity Questionnaire
The Baecke evaluates the impact of disease upon employment and leisure time activities.

Full Information

First Posted
March 4, 2010
Last Updated
April 14, 2015
Sponsor
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT01081275
Brief Title
Improving Hand Use in Multiple Sclerosis
Official Title
Rehabilitating Extremity Use After Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CI Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CAM treatments
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CI Therapy
Other Intervention Name(s)
Constraint-Induced Movement therapy
Intervention Description
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Intervention Type
Behavioral
Intervention Name(s)
CAM treatments
Other Intervention Name(s)
Complementary and Alternative Medicine
Intervention Description
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Primary Outcome Measure Information:
Title
Motor Activity Log (MAL)
Description
The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
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).
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
MSFC (Multiple Sclerosis Composite Measure)
Description
The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance).
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
SARA (Scale for the Assessment and Rating of Ataxia)
Description
The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
EDSS (Expanded Disability Status Scale)
Description
The EDSS is the world-wide standard to evaluate physical capability in persons with MS.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
Fatigue Severity Scale (FSS)
Description
The FSS evaluates the degree of overall fatigue experienced by the person with MS.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
MSIS-29 (Multiple Sclerosis Impact Scale)
Description
The MSIS-29 is a questionnaire that evaluates the impact of MS on daily living activities and quality of life.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
MSSS-88 (Multiple Sclerosis Spasticity Scale)
Description
The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Title
Baecke Activity Questionnaire
Description
The Baecke evaluates the impact of disease upon employment and leisure time activities.
Time Frame
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor W Mark, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18573826
Citation
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.
Results Reference
background
PubMed Identifier
29668401
Citation
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.
Results Reference
derived
PubMed Identifier
29668399
Citation
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.
Results Reference
derived

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Improving Hand Use in Multiple Sclerosis

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