An observational study in Amyotrophic Lateral Sclerosis and Motor Neuron Disease, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by IRCCS San Raffaele · Observational
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's planned enrollment of 60 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
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Based on previous experience and referral rates to the San Raffaele ALS Center (directed by the PI, including the Neurology and Neurorehabilitation wards and outpatient ALS clinic counting 50 new patients/year, 80 second opinion/year; 120 patients in care), the investigators plan to enroll at least 30 patients with ALS or any other MND phenotype, as well as 30 healthy controls with similar age and sex distribution, in line with sample size of previous studies ranging from 11 (Hausdorff et al., 2000) to 42 (Dubbioso et al., 2023). Healthy controls will be recruited by word of mouth, via consenting friends and non-consanguineous relatives who will be accompanying patients for study visits. Subjects will be assessed for suitability from their clinical notes or via a telephone screen. Given the cross-sectional, single-visit design of the present study, the investigators expect all patients to complete the study.
Patient inclusion criteria:
Healthy control inclusion criteria:
Exclusion Criteria
An individual (either patient or healthy control) who meets any of the following criteria will be excluded from participation in this study:
Patients with ALS and other MND phenotypes will undergo gait evaluation using wearable sensors in different conditions (single-task vs dual-task conditions).
Other: Clinical and gait evaluation
30 healthy controls with similar age and sex distribution will undergo the same evaluations as patients
Other: Clinical 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.
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
Time frame: 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
Time frame: Cross-sectional (baseline) evaluation
Walking velocity
Performance at 10 Meters Walking Test (10MWT) in terms of time (seconds)
Time frame: Cross-sectional (baseline) evaluation
Executive simple task
Ability to count backwards by 3 (number of correct subtractions in one minute)
Time frame: Cross-sectional (baseline) evaluation
Executive complex task
Ability to count backwards by 7 (number of correct subtractions in one minute)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Cross-sectional (baseline) evaluation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele