Skip to main content
Clinical Trials/NCT03711968
NCT03711968
Completed
N/A

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

University of Roma La Sapienza1 site in 1 country63 target enrollmentSeptember 13, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Roma La Sapienza
Enrollment
63
Locations
1
Primary Endpoint
Change in interoception
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2018
End Date
March 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Teresa Paolucci

Medical Doctor

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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
  • Rheumatological diseases
  • Scoliosis \>20° Cobb
  • Previous surgery on the spine
  • Pregnancy
  • Other physiotherapy in progress

Outcomes

Primary Outcomes

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

  • Change in posture(At the end of the cycle 1 (60 days), and at follow-up (120 days))
  • Change in body image 1(At the end of the cycle 1 (60 days), and at follow-up (120 days))
  • Change in balance 1(At the end of the cycle 1 (60 days), and at follow-up (120 days))
  • Change in balance 2(At the end of the cycle 1 (60 days), and at follow-up (120 days))
  • Change in QOL.(At the end of the cycle 1 (60 days), and at follow-up (120 days))
  • Change in body image 2(At the end of the cycle 1 (60 days), and at follow-up (120 days))

Study Sites (1)

Loading locations...

Similar Trials