NCT07899528 Interactive Intensive Gait Training in Walking Limitations
| NCT ID | NCT07899528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Neurologic Ambulation Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2026-10-01 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Sanaz Pournajaf
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele Roma
Frequently Asked Questions
Who can join the NCT07899528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neurologic Ambulation Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07899528 currently recruiting?
Yes, NCT07899528 is actively recruiting participants. Contact the research team at lucia.gatta@sanraffaele.it for enrollment information.
Where is the NCT07899528 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07899528 clinical trial?
NCT07899528 is sponsored by IRCCS San Raffaele Roma. The principal investigator is Sanaz Pournajaf at IRCCS San Raffaele Roma. The trial plans to enroll 112 participants.