Neurologic Ambulation DisorderGait-MAPNCT07899528
Interactive Intensive Gait Training in Walking Limitations
A study testing Intensive Interactive Gait Training and Conventional Gait Rehabilitation in people with Neurologic Ambulation Disorder, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurologic Ambulation Disorder
- What is being tested?
- Intensive Interactive Gait Training and Conventional Gait Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor disabilities (Functional Ambulation Category 1: ambulatory with physical assistance);
- Signing of informed consent for the study;
- Ability to adhere to study procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elena Sofia Cocco, PhD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Roma, Italy, 00163
Lucia Gatta, PhD, +39065225 ext. Ext. 3440, lucia.gatta@sanraffaele.it
Elena Sofia Cocco, PhD, +39 0652252338 ext. Ext. 32338, elenasofia.cocco@sanraffaele.it
About this study
Official title: Enhancing Ambulatory Performance: the Impact of Interactive Intensive Gait Training on Endurance and Social Participation in Real-Life Scenarios for People With Walking Limitations (an ICF-based RCT)
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.
- Conditions
- Neurologic Ambulation Disorder
- Being tested
- Intensive Interactive Gait Training, Conventional Gait Rehabilitation
- Keywords
- Interactive Intensive Gait Training, Endurance, Rehabilitation, Cost of walking, Disability, Ambulation
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Interactive Gait TrainingOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Interactive Gait Training (IIGT) - Experimental Group (EG) | Experimental | 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. Receives: Other: Intensive Interactive Gait Training |
| Conventional Gait Rehabilitation - Control Group (CG) | Active comparator | 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. Receives: Other: Conventional Gait Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (T0 - baseline); Day 15 (T1 - end of treatment)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (T0: baseline); Day 15 (T1: post-treatment); 3 months after completion of the treatment (T2: follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Neurologic Ambulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanaz Pournajaf, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899528
- Sponsor's protocol ID
- 297/SR/25
- Acronym
- Gait-MAP
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wohlrab M, Klenk J, Delgado-Ortiz L, Chambers M, Rochester L, Zuchowski M, Schwab M, Becker C, Jaeger SU. The value of walking: a systematic review on mobility and healthcare costs. Eur Rev Aging Phys Act. 2022 Dec 29;19(1):31. doi: 10.1186/s11556-022-00310-3.
PubMed 36581809Vargus-Adams JN, Majnemer A. International Classification of Functioning, Disability and Health (ICF) as a framework for change: revolutionizing rehabilitation. J Child Neurol. 2014 Aug;29(8):1030-5. doi: 10.1177/0883073814533595. Epub 2014 May 21.
PubMed 24850572van Hedel HJA, Rosselli I, Baumgartner-Ricklin S. Clinical utility of the over-ground bodyweight-supporting walking system Andago in children and youths with gait impairments. J Neuroeng Rehabil. 2021 Feb 8;18(1):29. doi: 10.1186/s12984-021-00827-1.
PubMed 33557834van Duijnhoven HJ, Heeren A, Peters MA, Veerbeek JM, Kwakkel G, Geurts AC, Weerdesteyn V. Effects of Exercise Therapy on Balance Capacity in Chronic Stroke: Systematic Review and Meta-Analysis. Stroke. 2016 Oct;47(10):2603-10. doi: 10.1161/STROKEAHA.116.013839. Epub 2016 Sep 15.
PubMed 27633021Van Criekinge T, Heremans C, Burridge J, Deutsch JE, Hammerbeck U, Hollands K, Karthikbabu S, Mehrholz J, Moore JL, Salbach NM, Schroder J, Veerbeek JM, Weerdesteyn V, Borschmann K, Churilov L, Verheyden G, Kwakkel G. Standardized measurement of balance and mobility post-stroke: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2024 Jan;38(1):41-51. doi: 10.1177/15459683231209154. Epub 2023 Oct 14.
PubMed 37837351Tomaszewski R, Mitrushina M. Utility of the Community Integration Questionnaire in a sample of adults with neurological and neuropsychiatric disorders receiving prevocational training. Disabil Rehabil. 2016;38(10):1016-22. doi: 10.3109/09638288.2015.1070296. Epub 2015 Aug 3.
PubMed 26289368Timmermans C, Roerdink M, van Ooijen MW, Meskers CG, Janssen TW, Beek PJ. Walking adaptability therapy after stroke: study protocol for a randomized controlled trial. Trials. 2016 Aug 26;17(1):425. doi: 10.1186/s13063-016-1527-6.
PubMed 27565425Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Pournajaf S, Goffredo M, Agosti M, Massucci M, Ferro S, Franceschini M; Italian Study Group on Implementation of Stroke Care (ISC Study). Community ambulation of stroke survivors at 6 months follow-up: an observational study on sociodemographic and sub-acute clinical indicators. Eur J Phys Rehabil Med. 2019 Aug;55(4):433-441. doi: 10.23736/S1973-9087.18.05489-8. Epub 2018 Dec 13.
PubMed 30543267Mirelman A, Herman T, Nicolai S, Zijlstra A, Zijlstra W, Becker C, Chiari L, Hausdorff JM. Audio-biofeedback training for posture and balance in patients with Parkinson's disease. J Neuroeng Rehabil. 2011 Jun 21;8:35. doi: 10.1186/1743-0003-8-35.
PubMed 21693054Madden RH, Dune T, Lukersmith S, Hartley S, Kuipers P, Gargett A, Llewellyn G. The relevance of the International Classification of Functioning, Disability and Health (ICF) in monitoring and evaluating Community-based Rehabilitation (CBR). Disabil Rehabil. 2014;36(10):826-37. doi: 10.3109/09638288.2013.821182. Epub 2013 Aug 14.
PubMed 23944180Lefeber N, De Buyzer S, Dassen N, De Keersmaecker E, Kerckhofs E, Swinnen E. Energy consumption and cost during walking with different modalities of assistance after stroke: a systematic review and meta-analysis. Disabil Rehabil. 2020 Jun;42(12):1650-1666. doi: 10.1080/09638288.2018.1531943. Epub 2019 Jan 22.
PubMed 30668170Larsson P, Edvardsen E, Gay CL, Ursin M, Ihle-Hansen H, Hagen PM, Lerdal PA. Changes in fatigue after first-ever ischemic stroke and their associations with changes in physical fitness, body composition, and physical activity. J Stroke Cerebrovasc Dis. 2025 Jun;34(6):108297. doi: 10.1016/j.jstrokecerebrovasdis.2025.108297. Epub 2025 Mar 28.
PubMed 40158782Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.
PubMed 31834165Fritz S, Merlo-Rains A, Rivers E, Brandenburg B, Sweet J, Donley J, Mathews H, deBode S, McClenaghan BA. Feasibility of intensive mobility training to improve gait, balance, and mobility in persons with chronic neurological conditions: a case series. J Neurol Phys Ther. 2011 Sep;35(3):141-7. doi: 10.1097/NPT.0b013e31822a2a09.
PubMed 21934376
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Ambulatory Performance: the Impact of Interactive Intensive Gait Training on Endurance and Social Participation in Real-Life Scenarios for People With Walking Limitations (an ICF-based RCT)
- ClinicalTrials.gov ID
- NCT07899528
- Acronym / sponsor ID
- Gait-MAP / 297/SR/25
- Conditions
- Neurologic Ambulation Disorder
- Keywords
- Interactive Intensive Gait Training, Endurance, Rehabilitation, Cost of walking, Disability, Ambulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Interactive Gait Training (IIGT) - Experimental Group (EG) | Experimental | Other: Intensive Interactive Gait TrainingParticipants 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. |
| Conventional Gait Rehabilitation - Control Group (CG) | Active comparator | Other: Conventional Gait RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Motor disabilities (Functional Ambulation Category 1: ambulatory with physical assistance);
- Signing of informed consent for the study;
- Ability to adhere to study procedures.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Interactive Gait TrainingIntensive 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. | Other | Intensive Interactive Gait Training (IIGT) - Experimental Group (EG) |
| Conventional Gait RehabilitationConventional 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. | Other | Conventional Gait Rehabilitation - Control Group (CG) |
Primary outcome
Cost of walking - CW
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - end of treatment)
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.
13 secondary outcomes
Mini Mental Status Examination (MMSE)
Time frame: Day 1 (T0 - baseline)
Fatigue Severity Scale (FSS)
Time frame: Day 1 (T0 - baseline9; Day 15 (T1 - post-treatment)
Medical Research Council scale (MRC)
Time frame: Day 1 (T0 - baseline); Day 15 (T1: post-treatment)
Modified Ashworth Scale (MAS)
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post- treatment)
6-Minute Walk Test (6MWT)
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Timed Up and Go (TUG)
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Timed Up and Go Dual Task (TUG-DT)
Time frame: Day 1(T0 - baseline); Day 15 (T1 - post-treatment)
10-Meter Walk Test (10MWT)
Time frame: Day 1 (T0 - baseline); Day 15 ( T1 - post-treatment)
Functional Ambulation Classification (FAC)
Time frame: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Modified Barthel Index (MBI)
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)
Time frame: Day 1 (T0: baseline); Day 15 (T1: post-treatment)
Activities-specific Balance Confidence Scale (ABC Scale)
Time frame: Day 1 (T0: baseline); Day 15 (T1: post-treatment)
Walking Handicap Scale (WHS)
Time frame: Day 1 (T0: baseline); Day 15 (T1: post-treatment); 3 months after completion of the treatment (T2: follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 36581809Wohlrab M, Klenk J, Delgado-Ortiz L, Chambers M, Rochester L, Zuchowski M, Schwab M, Becker C, Jaeger SU. The value of walking: a systematic review on mobility and healthcare costs. Eur Rev Aging Phys Act. 2022 Dec 29;19(1):31. doi: 10.1186/s11556-022-00310-3.
- Background: PubMed 24850572Vargus-Adams JN, Majnemer A. International Classification of Functioning, Disability and Health (ICF) as a framework for change: revolutionizing rehabilitation. J Child Neurol. 2014 Aug;29(8):1030-5. doi: 10.1177/0883073814533595. Epub 2014 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Sofia Cocco, PhD contact
Sanaz Pournajaf principal investigator
IRCCS San Raffaele Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Interactive Gait Training and Conventional Gait Rehabilitation in people with Neurologic Ambulation Disorder, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Gatta, PhD (+39065225 ext. Ext. 3440, lucia.gatta@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of walking - CW (time frame: Day 1 (T0 - baseline); Day 15 (T1 - end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899528, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.