Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability

NCT06381440 | Unknown DMC

• 1 other identifier: PROGR-EX_MNESYS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT.

Conditions

Multiple Sclerosis

Keywords

Robot Assisted Gait Training; Mobility; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Walking function

  The walking function will be assessed by the T25-FW test

  Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

Secondary Outcomes (17)

• Mobility

  Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

• Walking endurance

  Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

• Balance

  Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

• Spasticity

  Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

• Perceived quality of life

  Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

Study Arms (3)

Low-intensity RAGT at progressively increasing intensity

EXPERIMENTAL

Participants will receive 3 weekly treatment sessions of 3 hours each, for a period of 4 weeks and a total of 12 sessions. In the first two hours of treatment, an experienced physiotherapist will propose a programme based on stretching exercises, muscle strengthening and educational interventions. During the last hour of treatment, subjects allocated to this group will receive gait rehabilitation on the Lokomat device (Hocoma). The device in use will be set at 60% robotic assistance, 50% of load suspension, and a speed initially set at 1.0 km/h, with progressive increments of 0.1 km/h at each training session. The working time consists of bouts of 3 minutes of work alternated by 1 minute of recovery, to be repeated 8 times.

Device: Lokomat device (Hocoma AG, Volketswil, Switzerland).

Conventional RAGT

ACTIVE COMPARATOR

Participants will receive 3 weekly treatment sessions of 3 hours each, for a period of 4 weeks and a total of 12 sessions. In the first two hours of treatment, an experienced physiotherapist will propose a programme based on stretching exercises, muscle strengthening and educational interventions. During the last hour of treatment, subjects allocated to this group will receive gait rehabilitation on the Lokomat device (Hocoma). . In this case the parameters for setting the machine will be determined by the physiotherapist in charge for treatment administration in relation to the specific characteristics of the patient.

Device: Lokomat device (Hocoma AG, Volketswil, Switzerland).

Over ground training (OGT)

ACTIVE COMPARATOR

Participants will receive 3 weekly treatment sessions of 3 hours each, for a period of 4 weeks and a total of 12 sessions. In the first two hours of treatment, an experienced physiotherapist will propose a programme based on stretching exercises, muscle strengthening and educational interventions. During the last hour of treatment, the subject will perform a 40-minute walk on a flat surface, preceded by a warm-up phase and followed by a 10 minute warm-down phase each. Subjects will walk back and forth over a distance of approximately 30 metres using their walking aid.

Other: Conventional walking training

Interventions

Lokomat device (Hocoma AG, Volketswil, Switzerland). DEVICE

Robot Assisted Gait Training device

Conventional RAGT; Low-intensity RAGT at progressively increasing intensity

Conventional walking training OTHER

Self-paced supervised walking training

Over ground training (OGT)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of MS (primary or secondary progressive) without relapses in the preceding 3 months
• Disability rate defined by Expanded Disability Status Scale (EDSS) score from 6 to 7
• Ability to perform the Timed 25-Foot Walk (T25-FW) test
• Mini-Mental Status Examination score ≥ 24/30

You may not qualify if:

• Other (neurological) conditions that may affect motor function
• Medical conditions might interfere with the ability to complete the study protocol safely
• Presence of spasticity with a Modified Ashworth Scale (MAS) score \> 3 or retractions limiting the range of motion of the hip, knee or ankle
• MS relapses or medication changes or any other confounding factors during the study period
• Rehabilitation treatment or botulinum toxin injection in the 3 months preceding the start of the study

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Universita di Verona: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara

Ferrara, Emilia-Romagna, 44124, Italy

RECRUITING

Related Publications (2)

• Baroni A, Lamberti N, Perachiotti G, Crepaldi A, Piva G, Manfredini F, Straudi S. Low intensity interval robot-assisted gait training improves mobility in people with progressive multiple sclerosis: the PROGR-EX randomized controlled trial. Mult Scler Relat Disord. 2025 Dec;104:106777. doi: 10.1016/j.msard.2025.106777. Epub 2025 Sep 23.

  PMID: 41005019 DERIVED

• Baroni A, Lamberti N, Gandolfi M, Rimondini M, Bertagnolo V, Grassilli S, Zerbinati L, Manfredini F, Straudi S. Traditional versus progressive robot-assisted gait training in people with multiple sclerosis and severe gait disability: study protocol for the PROGR-EX randomised controlled trial. BMJ Open Sport Exerc Med. 2024 May 21;10(2):e002039. doi: 10.1136/bmjsem-2024-002039. eCollection 2024.

  PMID: 38779575 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

• Fabio Manfredini, PhD

  Ferrara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Straudi, PhD

CONTACT

0532238720; sofia.straudi@unife.it

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

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 24, 2024
• Study Start: November 15, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-01

Locations

IT (1)