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

Not yet recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease
• Interventions: Other: Clinical and gait evaluation

• Registration Number: NCT06541873
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Study Start: 2024-09
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ALS or other motor neuron disease phenotype	Clinical and gait evaluation	Patients with ALS and other MND phenotypes will undergo gait evaluation using wearable sensors in different conditions (single-task vs dual-task conditions).
Healthy controls	Clinical and gait evaluation	30 healthy controls with similar age and sex distribution will undergo the same evaluations as patients

Primary Outcome Measures

Name	Time	Method
Dual-task cost at 1-Minute Walking Test performance	Cross-sectional (baseline) evaluation	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
Dual-task cost at Timed Up and Go performance	Cross-sectional (baseline) evaluation	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

Secondary Outcome Measures

Name	Time	Method
Executive complex task	Cross-sectional (baseline) evaluation	Ability to count backwards by 7 (number of correct subtractions in one minute)
Muscle strength	Cross-sectional (baseline) evaluation	Medical Research Council \[MRC\] muscle testing in each tested muscle district ranging from 0 (worst performance) to 5 (best performance), as available from clinical charts
Executive simple task	Cross-sectional (baseline) evaluation	Ability to count backwards by 3 (number of correct subtractions in one minute)
Walking velocity	Cross-sectional (baseline) evaluation	Performance at 10 Meters Walking Test (10MWT) in terms of time (seconds)
Mnemonic ability	Cross-sectional (baseline) evaluation	Performance at Rey's Auditory Verbal Learning Test (RAVLT) (number of correct immediate recalls of 15 items presented verbally).
Functional disability	Cross-sectional (baseline) evaluation	ALS Functional Rating Scale scores \[ALSFRS-r\] ranging from 0 (worst functional status) to 48 (best functional status), as available from clinical charts
Cognitive impairment	Cross-sectional (baseline) evaluation	Edinburgh Cognitive Assessment Scale \[ECAS\] performance ranging from 0 (worst performance) to 136 (best performance), as available from clinical charts