Unraveling Early Walking Dysfunction in Non-disabled MS People: Assessment and Potential Therapeutic Interventions

NCT03492450 | Unknown DMC

• 1 other identifier: FISM Call 2016 cod. 2016/R/1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to set up a pilot study to investigate the effects of treadmill training in preventing the onset and worsening of walking impairments, balance deficits and fatigue.

Conditions

Multiple Sclerosis

Keywords

Treadmill training; Instrumented assessment; Disease progression

Outcome Measures

Primary Outcomes (2)

• Change in Six Minutes Walking Test

  Tool used to assess walking endurance

  Change from Baseline 6 minutes walking test scores at 8 weeks

• Change in Instrumented variables

  Gait asymmetry, Root mean squared of trunk Jerk and gait regularity on the vertical and medio-lateral plane estimated by autocorrelation coefficients (Moe-Nilssen, 2004) during the Six minutes walking test.

  Change from Baseline scores at 8 weeks

Secondary Outcomes (4)

• the Twelve-Item Walking Scale

  Change from Baseline Twelve-Item Walking Scale scores at 8 weeks

• the Twentyfive-foot walking test

  Change from Baseline Twentyfive-foot walking test scores at 8 weeks

• The Fatigue Severity Scale

  Change from Baseline Fatigue Severity Scale scores at 8 weeks

• the Nine hole peg test

  Change from Baseline Nine Hole Peg test scores at 8 weeks

Study Arms (2)

Control Group

NO INTERVENTION

All subjects continue participating in their normal daily and physical activities.

Treadmill training Group

EXPERIMENTAL

16 sessions (2 sessions/week for 8 weeks) of treadmill training as recommended in a review on this subject (Langeskov-Christensen, 2015) aimed at the reduction/stabilization of gait and balance disturbances.

Other: Treadmill training

Interventions

Treadmill training OTHER

Tailored treatment comprising of: 1) aerobic exercises with the aim of increasing fitness 2) task-oriented balance exercises on the treadmill to improve balance and 3) cognitive behavioral interventions to improve balance and gait during dual task activities.In accordance with the literature (Langeskov-Christensen, 2015, Latimer-Cheung, 2013) the treadmill training will be carried out without body weight support, but the participants will be allowed to use the handrails for balance support if needed. The training consists of three different walking sessions, each lasting for 10 minutes: 1) preferred walking speed at an increased slope; 2) walking doing dynamic balance exercises (for example walking with feet in tandem) 3) fast gait speed defined as a 10% increase in walking speed relative to preferred speed with dual task exercises. During the 8-week intervention, walking speed in session 3 will be gradually increased with 10% to 40% of preferred speed.

Treadmill training Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included will be patients residing in the centers' catchment areas
• Diagnosis of Multiple Sclerosis (Polman criteria)
• Stable disease course without worsening more than 1 Expanded Disability Status Scale (EDSS) point over the last 3 months
• EDSS \< 2.5,
• Disease duration shorter than or equal to 5 years,
• Releasing a written informed consent.

You may not qualify if:

• Multiple Sclerosis relapse within the previous three months
• Cognitive impairment (MMSE score \<27);
• Diagnosis of major depression (DSM-IV);
• Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
• Cardiovascular diseases;
• Unconfirmed or uncertain diagnosis of MS (Polman criteria)
• Other concomitant neurological diseases;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Gnocchi Irccs

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Disease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Davide Cattaneo, PhD

CONTACT

+390240308; dcattaneo@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: May 12, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 8, 2019

Record last verified: 2018-10

Locations

IT (1)