Interoception and Sense of Movement in the Patient With Multiple Sclerosis

Interoception and Sense of Movement in the Patient With Multiple Sclerosis: Proposal of a Rehabilitation Protocol

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Rehabilitative treatment protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00165
    • Umberto I Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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)	Other: Rehabilitative treatment protocol; A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in interoception	Multidimensional Assessment of Interoceptive Awareness (MAIA) total score minimum 0 - 40 obtained by sum of the 8 subscales: noticing 0 - 5, not distracting 0 - 5, not worring 0 - 5, attention regulation 0 - 5, emotional awareness 0 - 5, self regolation 0 - 5, body listening 0 - 5, Trusting 0 - 5. Higher values represent a better outcome.	At the end of the cycle 1 (60 days), and at follow-up (120 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in posture	Clinical assessment of spinal curve in normal posture and in self correction of posture.	At the end of the cycle 1 (60 days), and at follow-up (120 days)
Change in balance 1	Tinetti balance assessment tool. Total score 0 - 28 obtained by sum of 2 section: balance section 0 - 16, Gait section 0 - 16. Higher values represent a better outcome.	At the end of the cycle 1 (60 days), and at follow-up (120 days)
Change in balance 2	Baropodometry in normal posture and in self correction of posture.	At the end of the cycle 1 (60 days), and at follow-up (120 days)
Change in QOL.	The Short Form (12) Health Survey. The 12 questions includes one of two items from each of eight health concepts: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH). Two synthetic indices are obtained by a special software, Physical component summary (PCS - 12) score 18.4 - 57.8 and Mental component summary (MCS - 12). score 18.7 - 65.2. Higher values represent a better outcome.	At the end of the cycle 1 (60 days), and at follow-up (120 days)
Change in body image 1	Body Image Scale (BIS). Total score 0 - 30 obtained by the sum of 10 items 0 - 3, lower values represent a better outcome.	At the end of the cycle 1 (60 days), and at follow-up (120 days)
Change in body image 2	Trunk Appearance Perception Scale (TAPS). The TAPS includes 3 sets of figures that depict the trunk from 3 viewpoints: looking toward the back, looking toward the head with the patient bending over, and looking toward the front. This last view has two sets of drawings, one for males and one for females. Each drawing is scored from 1 (greatest deformity) to 5 (smallest deformity) and a mean score is obtained by adding the scores for the 3 drawings and dividing by 3. Higher values represent a better outcome.	At the end of the cycle 1 (60 days), and at follow-up (120 days)

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Valter Santilli, MD, University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2018
• Primary Completion (ACTUAL): January 7, 2019
• Study Completion (ACTUAL): March 20, 2019

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (ACTUAL): October 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 7, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Posture; Interoception; Sense of movement; body scheme
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 5125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No