Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aims of the study:

This is a single blind randomized-controlled trial to test the feasibility and the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated with a specific physical therapy (usual care).

Subjects and methods:

60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic (Azienda Ospedaliero-Universitaria di Ferrara).

Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented training (experimental group) or usual care (control group) through a randomization stratification approach, according to a block randomization of 6.

The experimental group will receive 10 task-oriented training sessions over 2 weeks (5 sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take part at the TOCT.

Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy outcome measures will be clinical test for gait speed (10m walking test), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking scale MSWS-12).

Outcome measures will be assessed the week before the treatment (T0), after the treatment (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded to the treatment.


Options:
A: Inclusion Criteria:

* males and females,
* community dwelling,
* age 18 or older
* diagnosis of multiple sclerosis in a stable phase, with relapses \> 3 months prior to study enrollment
* moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5

Exclusion Criteria:

* neurologic conditions in addition to multiple sclerosis that may affect motor function
* medical conditions likely to interfere with the ability to safely complete the study
* impaired cognitive functioning: Mini Mental Status Examination \< 24
B: Inclusion Criteria:

* Signed informed consent

  -\>18 years
* Primary progressive or secondary progressive MS according to the McDonald criteria
* 6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
* Maximal walking distance ≤ 10m

Exclusion Criteria:

* Patients are excluded if they:
* have dementia,alcoholism, or pacemaker treatment
* any serious medical comorbidities
* are pregnant
* have done systematic endurance training (\>1day/week) within the last 3 months.
* complete less than 80% of the planned training sessions
* medical conditions that exclude performance of a maximal endurance test.
C: Inclusion Criteria:

* Clinical diagnosis of MS by McDonald criteria. EDSS level between 4-6.5.

Exclusion Criteria:

* Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg, Uncontrolled diabetes (blood glucose 2X above the upper limit of normal or non-fasting blood drain).
* Symptomatic fall in blood pressure (\>30mm Hg), when upright in the body support apparatus, despite medical therapy.
* Circulatory problems, history of vascular claudication or pitting edema.
* Cognitive impairment MMSE \< 21.
* Body weight over 150 kg (structural limits of the Lokomat).
* Lower extremity injuries that limit range of motion or function.
* Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
* Unstable fractures.
* Pressure sores with any skin breakdown in areas in contact with the body harness or DGO apparatus.
* Chronic and ongoing alcohol or drug abuse.
* Pre-morbid, ongoing depression or psychosis.
D: 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.

Answer: A