An interventional study of Intensive Interactive Gait Training and Conventional Gait Rehabilitation in Neurologic Ambulation Disorder, sponsored by IRCCS San Raffaele Roma. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Treatment
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.
340 studies on the registry are indexed under Gait Disorders, Neurologic; 55 are open to participants now.
This study's planned enrollment of 112 is above the median of 30 across 255 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →IRCCS San Raffaele Roma is the lead sponsor of 69 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Participants assigned to this arm will receive Intensive Interactive Gait Training (IIGT) using a sensorized treadmill with body-weight support and interactive virtual reality-based exercises providing real-time visual and auditory feedback. The intervention will consist of approximately 15 sessions of 45 minutes each and will be integrated into the standard multidisciplinary rehabilitation program.
Other: Intensive Interactive Gait Training
Participants assigned to this arm will receive conventional gait rehabilitation with the same treatment period, duration, frequency, and intensity as the experimental group, according to national and international guidelines for neurological gait rehabilitation. The intervention will be integrated into the standard multidisciplinary rehabilitation program.
Other: Conventional Gait Rehabilitation
Intensive Interactive Gait Training (IIGT) will be delivered using a sensorized treadmill with body-weight support and interactive virtual reality-based exercises providing real-time visual and auditory feedback. The intervention will simulate real-life walking challenges and will be tailored to each participant's functional status, limitations, and rehabilitation goals. Training will be task-specific and of moderate-to-high intensity. Participants will receive approximately 15 sessions of 45 minutes each, integrated into the standard multidisciplinary rehabilitation program.
Conventional gait rehabilitation will be delivered over the same treatment period, with comparable duration, frequency, and intensity as the experimental intervention. Treatment will follow national and international recommendations for neurological gait rehabilitation and will be individualized according to each participant's functional status, limitations, and rehabilitation goals. The intervention will be integrated into the standard multidisciplinary rehabilitation program.
Cost of walking - CW
Cost of Walking (CW) represents the energy expenditure required to walk at a given speed and provides an index of walking efficiency. It will be assessed through cardiopulmonary exercise testing (CPET), based on oxygen consumption (VO₂), carbon dioxide production (VCO₂), and other metabolic parameters. Lower CW values indicate greater walking efficiency.
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - end of treatment)
Mini Mental Status Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a standardized cognitive screening tool used to assess global cognitive function. It evaluates several cognitive domains, including temporal and spatial orientation, memory, attention and calculation, language, and visuoconstructive abilities. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. The MMSE is widely used in clinical practice and research to screen for cognitive impairment and monitor changes in cognitive function over time.
Time frame: Day 1 (T0 - baseline)
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a standardized self-reported questionnaire used to assess the severity of fatigue and its impact on daily activities and functional performance. It consists of 9 items, each rated on a 7-point Likert scale (1 = strongly disagree; 7 = strongly agree). The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity and a more significant impact on daily functioning. The FSS is widely used in clinical practice and research to evaluate fatigue and monitor changes over time.
Time frame: Day 1 (T0 - baseline9; Day 15 (T1 - post-treatment)
Medical Research Council scale (MRC)
The Medical Research Council (MRC) Scale is a standardized clinical assessment tool used to evaluate muscle strength. It measures voluntary muscle contraction using a 6-point grading system ranging from 0 to 5, where 0 indicates no visible or palpable muscle contraction and 5 represents normal muscle strength. Intermediate scores reflect varying degrees of muscle activation and the ability to perform movements against gravity and resistance. Higher scores indicate greater muscle strength. The MRC scale is widely used in clinical practice and research to assess muscle weakness and monitor changes in motor function over time.
Time frame: Day 1 (T0 - baseline); Day 15 (T1: post-treatment)
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a standardized clinical assessment tool used to evaluate muscle spasticity by measuring resistance to passive movement. It assesses muscle tone using a 6-level grading system (0, 1, 1+, 2, 3, and 4), where 0 indicates no increase in muscle tone and 4 represents rigidity of the affected limb in flexion or extension. Higher scores indicate greater resistance to passive movement. The MAS is widely used in clinical practice and research to assess muscle hypertonia and monitor changes in muscle tone over time, particularly in patients with neurological disorders.
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post- treatment)
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) is a standardized functional assessment tool used to evaluate walking endurance and functional exercise capacity. It measures the total distance walked in meters over a period of 6 minutes, during which participants are instructed to walk as far as possible at a self-selected pace along a standardized walkway. The total distance covered represents the primary outcome measure, with greater distances indicating better functional exercise capacity and walking endurance. The 6MWT is widely used in clinical practice and research to assess functional mobility and monitor changes in walking performance over time, particularly in patients with neurological, cardiovascular, and respiratory disorders.
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Timed Up and Go (TUG)
The Timed Up and Go (TUG) is a standardized clinical assessment tool used to evaluate functional mobility, dynamic balance, and fall risk. The test measures the time required, in seconds, for a participant to stand up from a chair, walk a distance of 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down. The total completion time represents the primary outcome measure, with shorter times indicating better functional mobility and balance performance. The TUG is widely used in clinical practice and research to assess mobility limitations and monitor changes in functional performance over time, particularly in patients with neurological and musculoskeletal disorders.
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Timed Up and Go Dual Task (TUG-DT)
The Timed Up and Go Dual Task (TUG-DT) is a standardized clinical assessment tool used to evaluate functional mobility, dynamic balance, and cognitive-motor interference under dual-task conditions. The test measures the time required, in seconds, for a participant to stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down while simultaneously performing a secondary cognitive task, such as counting backward or verbal fluency. The total completion time represents the primary outcome measure, with shorter times indicating better dual-task mobility performance. The TUG-DT is widely used in clinical practice and research to assess cognitive-motor interactions, identify mobility limitations, and monitor changes in dual-task performance over time.
Time frame: Day 1(T0 - baseline); Day 15 (T1 - post-treatment)
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test (10MWT) is a standardized clinical assessment tool used to evaluate walking speed and functional mobility. The test measures the time required, in seconds, for a participant to walk a distance of 10 meters at a comfortable or maximum safe walking speed, according to the assessment protocol. Walking speed is calculated in meters per second (m/s) by dividing the measured distance by the time required to complete it. Higher walking speeds and shorter completion times indicate better walking performance. The 10MWT is widely used in clinical practice and research to assess gait impairments, functional mobility, and changes in walking performance over time, particularly in patients with neurological and musculoskeletal disorders
Time frame: Day 1 (T0 - baseline); Day 15 ( T1 - post-treatment)
Functional Ambulation Classification (FAC)
The Functional Ambulation Classification (FAC) is a standardized clinical assessment tool used to evaluate walking ability and the level of physical assistance required during ambulation. It classifies functional walking independence using a 6-point ordinal scale ranging from 0 to 5, where 0 indicates non-functional ambulation or the need for assistance from two or more people, and 5 represents complete independence in walking on various surfaces, including stairs. Higher scores indicate greater walking independence and reduced need for physical assistance. The FAC is widely used in clinical practice and research to assess functional mobility, monitor gait recovery, and evaluate changes in walking independence over time, particularly in patients with neurological disorders.
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Modified Barthel Index (MBI)
The Modified Barthel Index (MBI) is a standardized clinical assessment tool used to evaluate functional independence in activities of daily living (ADLs). It assesses 10 domains, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair climbing. The total score ranges from 0 to 100, with higher scores indicating greater functional independence and lower levels of disability. The MBI is widely used in clinical practice and research to assess functional limitations, monitor changes in independence over time, and evaluate rehabilitation outcomes, particularly in patients with neurological and musculoskeletal disorders.
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment); 3 months after completion of the treatment (T2: follow-up)
SF-36 Health Survey (SF36)
The 36-Item Short Form Health Survey (SF-36) is a standardized self-reported questionnaire used to assess health-related quality of life and overall health status. It consists of 36 items covering eight health domains, including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored on a 0-100 scale, with higher scores indicating better perceived health and quality of life. The SF-36 also provides two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). It is widely used in clinical practice and research to evaluate health-related quality of life and monitor changes in physical and mental well-being over time, particularly in patients with chronic conditions and disabilities.
Time frame: Day 1 (T0: baseline); Day 15 (T1: post-treatment)
Activities-specific Balance Confidence Scale (ABC Scale)
The Activities-specific Balance Confidence Scale (ABC Scale) is a standardized self-reported questionnaire used to assess an individual's confidence in maintaining balance while performing various activities of daily living. It consists of 16 items, each rated on a scale from 0% (no confidence) to 100% (complete confidence). The total score is calculated as the average of the 16 item scores, ranging from 0% to 100%, with higher scores indicating greater balance confidence and lower perceived risk of losing balance. The ABC Scale is widely used in clinical practice and research to assess balance-related self-efficacy, identify limitations in daily activities, and monitor changes in balance confidence over time, particularly in patients with neurological and musculoskeletal disorders.
Time frame: Day 1 (T0: baseline); Day 15 (T1: post-treatment)
Walking Handicap Scale (WHS)
The Walking Handicap Scale (WHS) is a standardized clinical assessment tool used to evaluate functional walking ability and the level of independence in household and community ambulation. It classifies walking performance using a 6-point ordinal scale ranging from 1 to 6, where 1 indicates walking limited to therapeutic or exercise purposes and 6 represents unrestricted community ambulation. Intermediate scores reflect varying degrees of walking independence and limitations in navigating different environments, including household and community settings. Higher scores indicate greater walking independence and fewer mobility restrictions. The WHS is widely used in clinical practice and research to assess functional walking limitations, community mobility, and changes in ambulation ability over time, particularly in patients with neurological disorders.
Time frame: Day 1 (T0: baseline); Day 15 (T1: post-treatment); 3 months after completion of the treatment (T2: follow-up)
Community Integration Questionnaire (CIQ)
The Community Integration Questionnaire (CIQ) is a standardized assessment tool used to evaluate the level of community participation and social integration in individuals with disabilities. The original version consists of 15 items covering three main domains: home integration, social integration, and productive activities, including work, education, and volunteer activities. The total score ranges from 0 to 29, with higher scores indicating greater independence and community integration. The CIQ is widely used in clinical practice and research to assess participation in everyday life, evaluate rehabilitation outcomes, and monitor changes in social and community functioning over time, particularly in patients with neurological disorders.
Time frame: 3 months after completion of the treatment (T2: follow-up)
Zarit Burden Interview (ZBI)
The Zarit Burden Interview (ZBI) is a standardized self-reported questionnaire used to assess the perceived burden experienced by caregivers of individuals with chronic illnesses or disabilities. The original version consists of 22 items evaluating the physical, emotional, social, and psychological impact of caregiving responsibilities. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). The total score ranges from 0 to 88, with higher scores indicating greater caregiver burden. The ZBI is widely used in clinical practice and research to assess caregiver distress, evaluate the impact of caregiving on quality of life, and monitor changes in perceived burden over time.
Time frame: 3 months after completion of the treatment (T2: follow-up)
Start is estimated for Oct 2026; primary completion for May 2029, 31 months later.
Of 181 non-industry interventional studies with no phase under Gait Disorders, Neurologic, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 31 months is above that.
Counting every sponsor, half of 194 studies reached it within 14 months; a quarter within 5 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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IRCCS San Raffaele Roma