Status unknownPhase 2Relapsing and progressiveNCT01081275

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • CI Therapy
  • CAM treatments

What it measured

Main measures

  • Motor Activity Log (MAL)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Arm and hand function

Other measures (8)

  • Wolf Motor Function Test (WMFT)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

  • MSFC (Multiple Sclerosis Composite Measure)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Disability progressionThinking and memoryWalking and mobilityArm and hand function
  • SARA (Scale for the Assessment and Rating of Ataxia)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Physical function
  • EDSS (Expanded Disability Status Scale)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Disability progression
  • Fatigue Severity Scale (FSS)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Fatigue
  • MSIS-29 (Multiple Sclerosis Impact Scale)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Quality of life (reported by participants)
  • MSSS-88 (Multiple Sclerosis Spasticity Scale)

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

    Spasticity
  • Baecke Activity Questionnaire

    Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Who could take part

Relapsing and progressive · 21 to 80

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2010

    2. Main results due

      Feb 2016

    3. Finished

      Mar 2016

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error