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

ConditionsAmyotrophic Lateral Sclerosis Motor Neuron Disease

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Diagnosis of dementia;

Medical conditions or substance abuse that could interfere with cognition;

Any (other) major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Clinical and gait evaluation
Other intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Patients with ALS or other motor neuron disease phenotype1 intervention

Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

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