NCT03711968

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

October 14, 2018

Last Update Submit

July 7, 2019

Conditions

Multiple Sclerosis

Keywords

InteroceptionSense of movementPosturebody scheme

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in posture

    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 1

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

  • +1 more secondary outcomes

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

Waiting list

NO INTERVENTION

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.

Interventions

Rehabilitative treatment protocolOTHER

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

Treatment group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Valter Santilli, MD

    University of Roma La Sapienza

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 19, 2018

Study Start

September 13, 2018

Primary Completion

January 7, 2019

Study Completion

March 20, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

IT(1)