Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Conditions
Brief 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.
Interventions
OTHERClinical and gait evaluation
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). Performance scores will be correlated with cognitive status and clinical features. Data will be collected at the baseline (i.e., only) visit within the enrollment timeframe of 3 years from study initiation.
Sponsors
IRCCS San Raffaele
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient inclusion criteria: * Age ≥ 18 years; * Clinical diagnosis of ALS or other MND phenotype; * Able to walk unassisted for at least 1 minute consecutively; * Oral and written informed consent to study participation. Healthy control inclusion criteria: 1. Age ≥ 18 years; 2. Age and sex distribution similar to patients (age range: mean age of patients years ± 15 years); 3. Able to walk unassisted for at least 1 minute consecutively; 4. Oral and written informed consent to study participation.
Exclusion criteria
An individual (either patient or healthy control) who meets any of the following criteria will be excluded from participation in this study: 1. Diagnosis of dementia; 2. Medical conditions or substance abuse that could interfere with cognition; 3. Any (other) major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dual-task cost at 1-Minute Walking Test performance | Cross-sectional (baseline) evaluation | 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 |
| Dual-task cost at Timed Up and Go performance | Cross-sectional (baseline) evaluation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Executive complex task | Cross-sectional (baseline) evaluation | Ability to count backwards by 7 (number of correct subtractions in one minute) |
| Mnemonic ability | Cross-sectional (baseline) evaluation | Performance at Rey's Auditory Verbal Learning Test (RAVLT) (number of correct immediate recalls of 15 items presented verbally). |
| Walking velocity | Cross-sectional (baseline) evaluation | Performance at 10 Meters Walking Test (10MWT) in terms of time (seconds) |
| Muscle strength | Cross-sectional (baseline) evaluation | 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 |
| Cognitive impairment | Cross-sectional (baseline) evaluation | Edinburgh Cognitive Assessment Scale \[ECAS\] performance ranging from 0 (worst performance) to 136 (best performance), as available from clinical charts |
| Functional disability | Cross-sectional (baseline) evaluation | ALS Functional Rating Scale scores \[ALSFRS-r\] ranging from 0 (worst functional status) to 48 (best functional status), as available from clinical charts |
| Executive simple task | Cross-sectional (baseline) evaluation | Ability to count backwards by 3 (number of correct subtractions in one minute) |
Contacts
Primary ContactEdoardo Gioele Spinelli, MD, PhD
Backup ContactElisabetta Sarasso, MSc, PT
Outcome results
None listed