Interoception and Sense of Movement in the Patient With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711968
• Other study ID #: 5125
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: July 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 20, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Rehabilitative treatment protocol
A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)