Amyotrophic Lateral SclerosisNCT06541873
Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- What is being tested?
- Clinical and gait evaluation
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DuALS - A Cross-sectional Observational Study of 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.
- Being tested
- Clinical and gait evaluation
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and gait evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Clinical and gait evaluation | |
| Healthy controls | 30 healthy controls with similar age and sex distribution will undergo the same evaluations as patients Receives: Other: Clinical and gait evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Cross-sectional (baseline) evaluation
Secondary outcomes (7)
Walking velocity
Performance at 10 Meters Walking Test (10MWT) in terms of time (seconds)
Measured: Cross-sectional (baseline) evaluation
Executive simple task
Ability to count backwards by 3 (number of correct subtractions in one minute)
Measured: Cross-sectional (baseline) evaluation
Executive complex task
Ability to count backwards by 7 (number of correct subtractions in one minute)
Measured: Cross-sectional (baseline) evaluation
Mnemonic ability
Performance at Rey's Auditory Verbal Learning Test (RAVLT) (number of correct immediate recalls of 15 items presented verbally).
Measured: Cross-sectional (baseline) evaluation
Functional disability
ALS Functional Rating Scale scores [ALSFRS-r] ranging from 0 (worst functional status) to 48 (best functional status), as available from clinical charts
Measured: Cross-sectional (baseline) evaluation
Muscle strength
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
Measured: Cross-sectional (baseline) evaluation
Cognitive impairment
Edinburgh Cognitive Assessment Scale [ECAS] performance ranging from 0 (worst performance) to 136 (best performance), as available from clinical charts
Measured: Cross-sectional (baseline) evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study startSep 2024 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541873
- Sponsor's protocol ID
- DuALS
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06541873
- Acronym / sponsor ID
- DuALS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ALS or other motor neuron disease phenotype | – | Other: Clinical and gait evaluationPatients with ALS and other MND phenotypes will undergo gait evaluation using wearable sensors in different conditions (single-task vs dual-task conditions). |
| Healthy controls | – | Other: Clinical and gait evaluation30 healthy controls with similar age and sex distribution will undergo the same evaluations as patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and gait evaluationThe 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. | Other | Healthy controls, Patients with ALS or other motor neuron disease phenotype |
Primary outcome
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
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
7 secondary outcomes
Walking velocity
Time frame: Cross-sectional (baseline) evaluation
Executive simple task
Time frame: Cross-sectional (baseline) evaluation
Executive complex task
Time frame: Cross-sectional (baseline) evaluation
Mnemonic ability
Time frame: Cross-sectional (baseline) evaluation
Functional disability
Time frame: Cross-sectional (baseline) evaluation
Muscle strength
Time frame: Cross-sectional (baseline) evaluation
Cognitive impairment
Time frame: Cross-sectional (baseline) evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edoardo Gioele Spinelli, MD, PhD (+39 (0)2 2643 3033, spinelli.edoardogioele@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task cost at 1-Minute Walking Test performance (time frame: Cross-sectional (baseline) evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.