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

Not yet recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

• 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

Primary Outcome Measures

Name	Time	Method
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
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

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)
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
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).