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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Treatments: Other: Clinical and gait evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT06541873

DuALS

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

60 participants in 2 patient groups

Patients with ALS or other motor neuron disease phenotype

Description:

Patients with ALS and other MND phenotypes will undergo gait evaluation using wearable sensors in different conditions (single-task vs dual-task conditions).

Treatment:

Other: Clinical and gait evaluation

Healthy controls

Description:

30 healthy controls with similar age and sex distribution will undergo the same evaluations as patients

Treatment:

Other: Clinical and gait evaluation