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

NCT06541873 | Not Yet Recruiting

• 1 other identifier: DuALS
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Walking velocity

  Cross-sectional (baseline) evaluation

• Executive simple task

  Cross-sectional (baseline) evaluation

• Executive complex task

  Cross-sectional (baseline) evaluation

• Mnemonic ability

  Cross-sectional (baseline) evaluation

• Functional disability

  Cross-sectional (baseline) evaluation

Study Arms (2)

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

Healthy controls

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

Other: Clinical and gait evaluation

Interventions

Clinical and gait evaluation 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; Patients with ALS or other motor neuron disease phenotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Age ≥ 18 years;
• Age and sex distribution similar to patients (age range: mean age of patients years ± 15 years);
• Able to walk unassisted for at least 1 minute consecutively;
• Oral and written informed consent to study participation.

You may not qualify if:

• An individual (either patient or healthy control) who meets any of the following criteria will be excluded from participation in this study:
• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Edoardo Gioele Spinelli, MD, PhD

CONTACT

+39 (0)2 2643 3033; spinelli.edoardogioele@hsr.it

Elisabetta Sarasso, MSc, PT

CONTACT

+39 (0)2 2643 3051; sarasso.elisabetta@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share