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Completed

NCT Number: NCT03711968

Interoception and Sense of Movement in the Patient With Multiple Sclerosis

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitative treatment protocol

Other

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

Primary outcomes

  1. Change in interoception

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    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.

Secondary outcomes

  1. Change in posture

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    Clinical assessment of spinal curve in normal posture and in self correction of posture.

  2. Change in balance 1

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    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.

  3. Change in balance 2

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    Baropodometry in normal posture and in self correction of posture.

  4. Change in QOL.

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    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.

  5. Change in body image 1

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    Body Image Scale (BIS). Total score 0 - 30 obtained by the sum of 10 items 0 - 3, lower values represent a better outcome.

  6. Change in body image 2

    Time frame: At the end of the cycle 1 (60 days), and at follow-up (120 days)

    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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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