NCT06219304Completed
Effect of High Intensity Training on Motor and Cognitive Functions
Evaluation of the Impact of Experimentally Induced Fatigability on Motor and Cognitive Functions. Effect of High Intensity Training on Motor and Cognitive Functions:a Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders. However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions. Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 22 Sept 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Multiple sclerosis
- NCT number
- NCT06219304
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Sept 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 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.
Prior treatment
- MS relapse within the previous three months;
- Other concomitant neurological disease;
Other illness
- Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
- Cardiovascular diseases;
Other
- Unable to comprehend the aims of the study and to follow test instructions;
- Diagnosis of major depression (DSM-5);
- Unconfirmed or uncertain diagnosis of MS (McDonald criteria)
- Patients already performing aerobic or walking exercise.
Who the study is looking for
- More than 18 years of age
- Clinical diagnosis of Multiple Sclerosis (MS)
- Stable disease course without worsening more than 1 EDSS point over the last 3 months, -EDSS between 1.5 and 6 points
- Must be able to maintain upright posture without any assistance for 30 seconds
- Must be able to release a written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Don Carlo Gnocchi Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.