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

NCT ID: NCT06541873

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-08-31

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.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

Clinical and gait evaluation

Intervention Type: OTHER

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

Clinical and gait evaluation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Prof. Massimo Filippi

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Edoardo Gioele Spinelli, MD, PhD

Role: CONTACT

spinelli.edoardogioele@hsr.it

+39 (0)2 2643 3033

Elisabetta Sarasso, MSc, PT

Role: CONTACT

sarasso.elisabetta@hsr.it

+39 (0)2 2643 3051

Other Identifiers

DuALS

Identifier Type: -

Identifier Source: org_study_id