Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis

DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: Clinical and gait evaluation

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Edoardo Gioele Spinelli, MD, PhD; Phone Number: +39 (0)2 2643 3033; Email: spinelli.edoardogioele@hsr.it
• Study Contact Backup: Name: Elisabetta Sarasso, MSc, PT; Phone Number: +39 (0)2 2643 3051; Email: sarasso.elisabetta@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with ALS or other motor neuron disease phenotype; 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; 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.
Healthy controls; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: DuALS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No