Clinical trial NCT03711968: Interoception and Sense of Movement in the Patient With Multiple Sclerosis
Official title: Interoception and Sense of Movement in the Patient With Multiple Sclerosis: Proposal of a Rehabilitation Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Interoception
Sense of movement
Posture
body scheme
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in interoception
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
Secondary outcomes:
measure: Change in posture
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
measure: Change in balance 1
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
measure: Change in balance 2
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
measure: Change in QOL.
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
measure: Change in body image 1
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
measure: Change in body image 2
timeFrame: At the end of the cycle 1 (60 days), and at follow-up (120 days)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: University of Roma La Sapienza
name: Valter Santilli, MD
role: STUDY_DIRECTOR
References: