Interoception and Sense of Movement in the Patient With Multiple Sclerosis

NCT ID: NCT03711968

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2019-03-20

Brief Summary

To evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks for the improvement of body awareness and the motor scheme in the patient with multiple sclerosis (EDSS <2.5).

Primary outcome: improvement of the interoception (awareness of the body) and of the related motor capacity Secondary outcomes: improvement of balance and postural self-correction control

Detailed Description

Multiple sclerosis (MS) is a chronically progressive, disabling, autoimmune disease that affects the central nervous system causing a wide spectrum of sensory, motor, and neuropsychiatric signs and symptoms. In the great part of patients with MS, there is a cognitive deficit that can start already in the early stages of the disease. Disability related to the disease is usually investigated through the Expanded Disability Status Scale (EDSS), however, the scale does not evaluate some very disabling aspects of the disease such as diplopia, fatigue and the impact of cognitive disorders.

The posture and postural self-correction are dependent on the image that anyone have of his own body and on the perception of it in the space, both internal and external. In multiple sclerosis proprioception and interoception are often altered due to motor and cognitive impairment.

The investigators propose a rehabilitative protocol that combine postural rehabilitation with specific visual-spatial tasks, relaxation sessions with self-awareness improvement and cognitive rehabilitation.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Rehabilitative treatment protocol:

Therapeutic exercise 8 mono-weekly sessions, 5 patients per group, duration 60 minutes and two sessions of single treatment, duration 60 minutes (duration of treatment about two months, considering also any recovery sessions)

Group Type: ACTIVE_COMPARATOR

Rehabilitative treatment protocol

Intervention Type: OTHER

A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.

Waiting list

Intervention: The WL patients will be taken into the same treatment at the end of the experimental protocol, after T2 evaluation. In this period they act like a control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rehabilitative treatment protocol

A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI<30
• Diagnosis of multiple sclerosis for less than 10 years
• Course of relapsing remitting type
• Relapse-free for at least 30 days
• EDSS score <2,5
• FDA-approved disease-modifying therapy for at least 6 months
• MMSE>24
• Public health guidelines for participating in physical activity

Exclusion Criteria

• Other concurrent neurological and psychiatric diseases (like schizophrenia, bipolar disorder I or II and substance abuse disorders)
• Oncological diseases
• Cardiovascular disease, pacemaker carrier
• Diabetes
• Rheumatological diseases
• Scoliosis >20° Cobb
• Previous surgery on the spine
• Pregnancy
• Other physiotherapy in progress

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valter Santilli, MD

Role: STUDY_DIRECTOR

University of Roma La Sapienza

Locations

Umberto I Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

5125

Identifier Type: -

Identifier Source: org_study_id