Robot-assisted Gait Training on Mobility in Severely Disabled Multiple Sclerosis Patients

NCT02421731 | Completed

• 1 other identifier: Regionale WP3
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Gait disabilities affect personal activities and quality of life of progressive multiple sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of walking movements and imitation of a nearly normal gait pattern during treadmill training at a higher speed has been developed and recently introduced in clinical settings. However, until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group of stroke, spinal cord injury and MS subjects. In addition, the training-induced neural and biological changes potentially related to the mechanisms of recovery remain undefined. The primary aims of this study are: to test the feasibility of RAGT in a group of progressive severely disabled MS patients and to test the hypothesis that this intensive intervention could have higher benefit, compared with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot Walk (T25FW) The secondary aims of this study are: to determine whether fatigue, Quality of life, balance and locomotor function are improved by RAGT; to determine whether gait training influences markers of plasticity including clinical and circulating biomarkers to search for a possible correlation between clinical outcomes and clinical and circulating biomarkers

Conditions

Multiple Sclerosis

Keywords

Rehabilitation; Gait

Outcome Measures

Primary Outcomes (1)

• Timed 25 Foot Walk

  The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet (7.62m) as quickly as possible, but safely, using the prescribed assistive devices.

  weeks: 0,2,4,16

Secondary Outcomes (9)

• Six-Minute Walking Test

  weeks: 0,2,4,16

• Berg Balance Scale

  weeks: 0,2,4,16

• Up and Go Test

  weeks: 0,2,4,16

• Fatigue Severity Scale

  weeks: 0,2,4,16

• Modified Ashworth Scale

  weeks: 0,2,4,16

Study Arms (2)

Robot-assisted gait training

EXPERIMENTAL

This group will receive rehabilitation treatment based on robot-assisted gait training.

Device: Robot-assisted gait training

Conventional therapy

ACTIVE COMPARATOR

This group will receive conventional rehabilitation therapy.

Other: Conventional therapy

Interventions

Robot-assisted gait training DEVICE

Patients will receive 12 training sessions, lasting for an hour with 30 minutes of real walking time, over 4 weeks (3 sessions/week) of RAGT. Subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these parameters according to subject characteristics and demand level. As training will progress, adjustments in the three parameters previously described will be performed.

Robot-assisted gait training

Conventional therapy OTHER

The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.

Conventional therapy

Eligibility Criteria

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

You may qualify if:

• severe gait impairments defined as EDSS 6-7
• lack of EDSS worsening in the last 3 months

You may not qualify if:

• neurologic conditions in addition to MS that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
• impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
• spasticity (Ashworth scale \>3) or contractures that may limit range of motion or function
• changes in disease modifying drug therapy or in any other confounding factor during the study.

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Regione Emilia-Romagna: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

Ferrara University Hospital

Ferrara, Italy

Location

Related Publications (3)

• Manfredini F, Straudi S, Lamberti N, Patergnani S, Tisato V, Secchiero P, Bernardi F, Ziliotto N, Marchetti G, Basaglia N, Bonora M, Pinton P. Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity. Diagnostics (Basel). 2020 Oct 17;10(10):834. doi: 10.3390/diagnostics10100834.

  PMID: 33080806 DERIVED

• Straudi S, Manfredini F, Lamberti N, Martinuzzi C, Maietti E, Basaglia N. Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial. Mult Scler. 2020 May;26(6):716-724. doi: 10.1177/1352458519833901. Epub 2019 Mar 4.

  PMID: 30829117 DERIVED

• Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.

  PMID: 28241776 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sofia Straudi, MD

  Ferrara Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: April 21, 2015
• Study Start: February 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 8, 2023

Record last verified: 2017-02

Locations

IT (1)