Clinical trial NCT06541873: Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
Official title: DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: Dual-task cost at 1-Minute Walking Test performance
timeFrame: Cross-sectional (baseline) evaluation
measure: Dual-task cost at Timed Up and Go performance
timeFrame: Cross-sectional (baseline) evaluation
Secondary outcomes:
measure: Walking velocity
timeFrame: Cross-sectional (baseline) evaluation
measure: Executive simple task
timeFrame: Cross-sectional (baseline) evaluation
measure: Executive complex task
timeFrame: Cross-sectional (baseline) evaluation
measure: Mnemonic ability
timeFrame: Cross-sectional (baseline) evaluation
measure: Functional disability
timeFrame: Cross-sectional (baseline) evaluation
measure: Muscle strength
timeFrame: Cross-sectional (baseline) evaluation
measure: Cognitive impairment
timeFrame: Cross-sectional (baseline) evaluation
Other outcomes:
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