Clinical trial NCT06381440: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability
Official title: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability: Study Protocol for a the PROGR-EX Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Robot Assisted Gait Training
Mobility
Biomarkers
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Universita di Verona
name: Università degli Studi di Ferrara
First posted: 2024-04-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

Detailed description: Gait disorders are the most frequent symptoms associated to multiple sclerosis (MS).Robot-assisted gait training (RAGT) in people with MS (PwMS) has been proposed as a possible effective treatment option for severe motor disability. Although RAGT continues to prove effective in increasing patient mobility, no significant superiority was found when compared to intensive overground gait rehabilitation (OGT). In PwMS, RAGT at high-intensity may enhance fatigue and spasticity, compromising the effectiveness and applicability of the intervention.

This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT in PwMS and moderate to severe walking impairment.

We will recruit 24 PwMS from the patients afferent to Outpatient Rehabilitation Clinic at University Hospital of Ferrara and we will assign them to one of the three treatment groups: low-intensity RAGT at progressively increasing intensity, conventional RAGT and OGT. All participants will receive 3 weekly treatment sessions of 3 hours each for 4 weeks. In the first 2 hours of treatment, an experienced physiotherapist will propose a programme based on stretching exercises, muscle strengthening and educational interventions. During the last hour, subjects will undergo specific gait training according to the assignment group. Subjects allocated to low-intensity RAGT at progressively increasing intensity group will receive gait rehabilitation on the Lokomat device 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. Subjects allocated to conventional RAGT will receive gait rehabilitation on the Lokomat device and the machine parameters will be determined based on the patient's characteristics. Subjects allocated to OGT will perform a 40-minute walk on a flat surface supervised by a physiotherapist. Outcomes will be assessed before and after treatment and at 3-month follow-up. The primary outcome is walking speed. Secondary outcomes include mobility and balance, psychological measures, muscle oxygen consumption, electrical and hemodynamic brain activity, urinary biomarkers, usability, and acceptability of robotic devices for motor rehabilitation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Walking function
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
Secondary outcomes:
measure: Mobility
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Walking endurance
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Balance
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Spasticity
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Perceived quality of life
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Perceived walking ability
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Fatigue
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Anxiety
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Depression
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Kinesiophobia
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Adaptation to medical condition
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Coping strategies
timeFrame: Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Muscle oxygen consumption
timeFrame: Data changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Hemodynamic cortical activation
timeFrame: Data changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: Electrical brain activity
timeFrame: Data changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).
measure: miRNA expression
timeFrame: Data changes before (T0) and after (T1) the twelve sessions of treatment.
measure: Acceptability of robot intervention
timeFrame: Scores registered after (T1) the twelve sessions of robotic treatment.
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
state: Emilia Romagna
Study officials:
affiliation: Ferrara University
name: Fabio Manfredini, PhD
role: PRINCIPAL_INVESTIGATOR
References: