NCT06541873Not yet recruiting
Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- Sept 2024
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06541873
What you commit to
- Study type: Observational
- Planned participants: 60
- From Sept 2024 to the primary completion date, 31 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- An individual (either patient or healthy control) who meets any of the following criteria will be excluded from participation in this study:
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.