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Interoception and Sense of Movement in the Patient With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rehabilitative treatment protocol
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Interoception, Sense of movement, Posture, body scheme

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Umberto I Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment group

Waiting list

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in posture
Clinical assessment of spinal curve in normal posture and in self correction of posture.
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.
Change in balance 2
Baropodometry in normal posture and in self correction of posture.
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.
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.
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.

Full Information

First Posted
October 14, 2018
Last Updated
July 7, 2019
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT03711968
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Interoception, Sense of movement, Posture, body scheme

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitative treatment protocol
Intervention Description
A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.
Primary Outcome Measure Information:
Title
Change in interoception
Description
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.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)
Secondary Outcome Measure Information:
Title
Change in posture
Description
Clinical assessment of spinal curve in normal posture and in self correction of posture.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)
Title
Change in balance 1
Description
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.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)
Title
Change in balance 2
Description
Baropodometry in normal posture and in self correction of posture.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)
Title
Change in QOL.
Description
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.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)
Title
Change in body image 1
Description
Body Image Scale (BIS). Total score 0 - 30 obtained by the sum of 10 items 0 - 3, lower values represent a better outcome.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)
Title
Change in body image 2
Description
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.
Time Frame
At the end of the cycle 1 (60 days), and at follow-up (120 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valter Santilli, MD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Study Director
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Interoception and Sense of Movement in the Patient With Multiple Sclerosis

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