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NCT Number: NCT06541873

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. Dual-task cost at 1-Minute Walking Test performance

    Time frame: 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

  2. Dual-task cost at Timed Up and Go performance

    Time frame: 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 outcomes

  1. Walking velocity

    Time frame: Cross-sectional (baseline) evaluation

    Performance at 10 Meters Walking Test (10MWT) in terms of time (seconds)

  2. Executive simple task

    Time frame: Cross-sectional (baseline) evaluation

    Ability to count backwards by 3 (number of correct subtractions in one minute)

  3. Executive complex task

    Time frame: Cross-sectional (baseline) evaluation

    Ability to count backwards by 7 (number of correct subtractions in one minute)

  4. Mnemonic ability

    Time frame: Cross-sectional (baseline) evaluation

    Performance at Rey's Auditory Verbal Learning Test (RAVLT) (number of correct immediate recalls of 15 items presented verbally).

  5. Functional disability

    Time frame: 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

  6. Muscle strength

    Time frame: 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

  7. Cognitive impairment

    Time frame: Cross-sectional (baseline) evaluation

    Edinburgh Cognitive Assessment Scale [ECAS] performance ranging from 0 (worst performance) to 136 (best performance), as available from clinical charts

Study contacts

Contact information is provided by the study sponsor or research team.

Edoardo Gioele Spinelli, MD, PhD

CONTACT

[email protected]

+39 (0)2 2643 3033

Elisabetta Sarasso, MSc, PT

CONTACT

[email protected]

+39 (0)2 2643 3051

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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