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NCT07899528
Interactive Intensive Gait Training in Walking Limitations
Conditions: Neurologic Ambulation Disorder
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 112
Sponsor: IRCCS San Raffaele Roma
Location: IRCCS San Raffaele Roma Italy
Summary
Gait-MAP is a prospective, randomized, single-blind clinical trial designed to evaluate the effectiveness of an Intensive Interactive Gait Training (IIGT) program in adults with neurological conditions associated with pyramidal syndrome and walking limitations. The study aims to determine whether interactive treadmill-based gait training, incorporating body-weight support, virtual reality exercises, and real-time visual and auditory feedback, can improve walking efficiency, endurance, functional mobility, and participation in daily and community life compared with conventional gait rehabilitation.
Participants will be randomly assigned to either the experimental group (EG), receiving IIGT, or the control group (CG), receiving conventional gait rehabilitation with comparable duration, frequency, and intensity. The experimental intervention will consist of approximately 15 sessions of 45 minutes and will include task-specific exercises and controlled environmental challenges designed to reproduce real-life walking situations. Both interventions will be integrated into the participants' standard multidisciplinary rehabilitation program.
The primary outcome is the Cost of Walking (CW), assessed through cardiopulmonary exercise testing (CPET), including oxygen consumption (VO₂), carbon dioxide production (VCO₂), and other physiological parameters. Secondary outcomes will assess walking endurance and mobility, motor function, fatigue, balance confidence, independence, quality of life, and community participation using an ICF-based assessment framework. Measures include the 6-Minute Walk Test, 10-Meter Walk Test, Timed Up and Go and dual-task TUG, Functional Ambulation Classification, Modified Barthel Index, SF-36, Activities-specific Balance Confidence Scale, and Walking Handicap Scale. Participants will be assessed at baseline, during treatment, at the end of treatment, and at a 3-month follow-up. The study is expected to determine whether IIGT can enhance walking efficiency and endurance while promoting greater autonomy and transfer of rehabilitation gains to real-life mobility and social participation.
Eligibility Criteria
Inclusion Criteria:
* Motor disabilities (Functional Ambulation Category 1: ambulatory with physical assistance);
* Signing of informed consent for the study;
* Ability to adhere to study procedures.
Exclusion Criteria:
* Inability to adhere to the exercise program due to poor compliance;
* Severe cardiovascular or respiratory conditions contraindicating intensive aerobic rehabilitation;
* Inability to stand or walk, even with maximum assistance;
* Cognitive barriers to understanding instructions;
* Pregnancy and uncontrolled comorbidities;
* Participants who have not signed the informed consent for the study.
Source: ClinicalTrials.gov (NCT07899528). StuddyBuddy aggregates publicly available trial information.