The Effects of Vestibular Rehabilitation on MS-related Fatigue and Upright Postural Control: a Randomized Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT01216137

What it found

Paper found, not read

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

What was tested

Treatment tested

  • Exercise: Vestibular Rehabilitation

Compared with

  • Exercise

What it measured

Main measures

  • Self-reported fatigue

    10 weeks

    Fatigue
  • Upright postural control

    10 weeks

  • Walking capacity

    10 weeks

    Walking and mobility

Other measures (2)

  • Self-reported dizziness

    10 weeks

  • Self-reported depression

    10 weeks

    Mood and sleep

Who could take part

MS (type not specified) · 18 to 65 · EDSS 0.0 to 6.0

Show the full criteria

Inclusion criteria

* (1) Clinically definite MS confirmed by a board certified Neurologist * (2) Kurtzke Expanded Disability Status Scale (EDSS) 0.0 to 6.0 (ranges and corresponding ambulatory status: 0.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5 impaired ambulatory status without assistive device; 6.0 impaired ambulatory status with intermittent or unilateral constant assistive device) * (3) Age: 18 to 65 years (65 years has been set as the upper limit of age to decrease the possible age-related changes in physical strength, endurance, and upright postural control) * (4) Male or Female (MS affects both gender types) * (5) Comprehension of the general concept of the study and ability to make informed consent (see Section I. Special Consent Issues). (6) Minorities included * (7) Self-reported fatigue level on the Modified Fatigue Impact Scale (MFIS) of a total score > 45 (This criterion has been used in previous studies investigating treatment for MS-related fatigue utilizing the MFIS) * (8) Sensory organization test (SOT) composite score of \< 72

Exclusion criteria

* (1) Non-ambulatory * (2) Utilization of agents to control fatigue: i.e. medications: Amantadine, Pemoline, Dexedrine Amphetamine, Methylphenidate, Provigil, Ritalin, Prokarin. * (3) Utilization of medication(s) that have known possible side effects of fatigue such as: skeletal muscle relaxants (i.e. Baclofen, Zanaflex), Statin Drugs, pain medication (i.e. Opioids, tricyclic antidepressants (TCAs), anti-epileptic drugs (AEDs) * (4) Any other possible cause of fatigue: major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer * (5) Other neurological disorder which might contribute to significant balance problems, including cerebral vascular accident, peripheral neuropathy (separate from MS diagnosis, such as diabetes mellitus), peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign positional paroxysmal vertigo, Meniere's disease, acoustic neuroma) * (6) Change in MS specific medication (for disease modification) in the last three months * (7) Documented MS-related exacerbation in the last six months * (8) Any medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise testing and/or result in limitations for participation in an active exercise program or aerobic exercise program, as recommended by the American College of Sports Medicine (ACSM) * (9) Participation in an exercise routine specifically designed as a vestibular and/or aerobic exercise program within eight weeks prior to study participation.

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

About this trial

In the sponsor's words

The purpose of this study was to test the feasibility and effectiveness of a novel exercise intervention for individuals who live with multiple sclerosis (MS).

Papers

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History

    1. Started

      Jan 2007

    2. Main results due

      Jul 2010

    3. Finished

      Oct 2010

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