Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
NCT Number: NCT06541873
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Amyotrophic Lateral Sclerosis|Motor Neuron Disease
Interventions: OTHER: Clinical and gait evaluation
Sponsor: IRCCS San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-08-31

Summary:
The investigators hypothesize a relevant impact of cognitive status over gait performance in patients with amyotrophic lateral sclerosis (ALS), contributing to poor mobility and representing a relevant risk for falls. The present observational, cross-sectional study on ambulatory patients with ALS will evaluate gait performance using different sets of dual-task conditions to demonstrate the importance of cognitive aspects in rehabilitation programs for these patients. The dual-task conditions to be assessed during gait performance will include: counting backwards by 3 (executive simple task); counting backwards by 7 (executive complex task); mnemonic recall of the Rey's Auditory Verbal Learning Test (RAVLT). Patients' performance will be compared with a group of healthy controls with similar age and sex distribution in order to highlight the specific effects of the disease.

Primary Outcome Measures: Dual-task cost at 1-Minute Walking Test performance, Percentage of variability of gait scores obtained at the 1-Minute Walking Test (1minWT) (i.e., meters walked in one minute) in dual-task vs. single-task conditions in ALS patients compared with healthy controls, Cross-sectional (baseline) evaluation|Dual-task cost at Timed Up and Go performance, Percentage of variability of gait scores obtained at the Timed Up and Go (TUG) test (i.e., time in seconds) in dual-task vs. single-task conditions in ALS patients compared with healthy controls, Cross-sectional (baseline) evaluation
Secondary Outcome Measures: Walking velocity, Performance at 10 Meters Walking Test (10MWT) in terms of time (seconds), Cross-sectional (baseline) evaluation|Executive simple task, Ability to count backwards by 3 (number of correct subtractions in one minute), Cross-sectional (baseline) evaluation|Executive complex task, Ability to count backwards by 7 (number of correct subtractions in one minute), Cross-sectional (baseline) evaluation|Mnemonic ability, Performance at Rey's Auditory Verbal Learning Test (RAVLT) (number of correct immediate recalls of 15 items presented verbally)., Cross-sectional (baseline) evaluation|Functional disability, ALS Functional Rating Scale scores \[ALSFRS-r\] ranging from 0 (worst functional status) to 48 (best functional status), as available from clinical charts, Cross-sectional (baseline) evaluation|Muscle strength, Medical Research Council \[MRC\] muscle testing in each tested muscle district ranging from 0 (worst performance) to 5 (best performance), as available from clinical charts, Cross-sectional (baseline) evaluation|Cognitive impairment, Edinburgh Cognitive Assessment Scale \[ECAS\] performance ranging from 0 (worst performance) to 136 (best performance), as available from clinical charts, Cross-sectional (baseline) evaluation