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Interactive Intensive Gait Training in Walking Limitations (Gait-MAP)

2 novembre 2026 aggiornato da: IRCCS San Raffaele Roma

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

112

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Elena Sofia Cocco, PhD

Luoghi di studio

    • Italy
      • Roma, Italy, Italia, 00163
        • Reclutamento
        • IRCCS San Raffaele
        • Investigatore principale:
          • Sanaz Pournajaf, DPT, PhD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intensive Interactive Gait Training (IIGT) - Experimental Group (EG)

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.

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.

Comparatore attivo: Conventional Gait Rehabilitation - Control Group (CG)

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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cost of walking - CW
Lasso di tempo: 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.

Day 1 (T0 - baseline); Day 15 (T1 - end of treatment)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mini Mental Status Examination (MMSE)
Lasso di tempo: Day 1 (T0 - baseline)

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.

Day 1 (T0 - baseline)
Fatigue Severity Scale (FSS)
Lasso di tempo: Day 1 (T0 - baseline9; Day 15 (T1 - post-treatment)

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.

Day 1 (T0 - baseline9; Day 15 (T1 - post-treatment)
Medical Research Council scale (MRC)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 (T1: post-treatment)

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.

Day 1 (T0 - baseline); Day 15 (T1: post-treatment)
Modified Ashworth Scale (MAS)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 (T1 - post- treatment)

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.

Day 1 (T0 - baseline); Day 15 (T1 - post- treatment)
6-Minute Walk Test (6MWT)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)

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.

Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Timed Up and Go (TUG)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)

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.

Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Timed Up and Go Dual Task (TUG-DT)
Lasso di tempo: Day 1(T0 - baseline); Day 15 (T1 - post-treatment)

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.

Day 1(T0 - baseline); Day 15 (T1 - post-treatment)
10-Meter Walk Test (10MWT)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 ( T1 - post-treatment)

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

Day 1 (T0 - baseline); Day 15 ( T1 - post-treatment)
Functional Ambulation Classification (FAC)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)

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.

Day 1 (T0 - baseline); Day 15 (T1 - post-treatment)
Modified Barthel Index (MBI)
Lasso di tempo: Day 1 (T0 - baseline); Day 15 (T1 - post-treatment); 3 months after completion of the treatment (T2: follow-up)

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.

Day 1 (T0 - baseline); Day 15 (T1 - post-treatment); 3 months after completion of the treatment (T2: follow-up)
SF-36 Health Survey (SF36)
Lasso di tempo: Day 1 (T0: baseline); Day 15 (T1: post-treatment)

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.

Day 1 (T0: baseline); Day 15 (T1: post-treatment)
Activities-specific Balance Confidence Scale (ABC Scale)
Lasso di tempo: Day 1 (T0: baseline); Day 15 (T1: post-treatment)

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.

Day 1 (T0: baseline); Day 15 (T1: post-treatment)
Walking Handicap Scale (WHS)
Lasso di tempo: Day 1 (T0: baseline); Day 15 (T1: post-treatment); 3 months after completion of the treatment (T2: follow-up)

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.

Day 1 (T0: baseline); Day 15 (T1: post-treatment); 3 months after completion of the treatment (T2: follow-up)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Community Integration Questionnaire (CIQ)
Lasso di tempo: 3 months after completion of the treatment (T2: follow-up)

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.

3 months after completion of the treatment (T2: follow-up)
Zarit Burden Interview (ZBI)
Lasso di tempo: 3 months after completion of the treatment (T2: follow-up)

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.

3 months after completion of the treatment (T2: follow-up)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Sanaz Pournajaf, IRCCS San Raffaele Roma

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2026

Completamento primario (Stimato)

1 maggio 2029

Completamento dello studio (Stimato)

1 agosto 2029

Date di iscrizione allo studio

Primo inviato

14 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 ottobre 2026

Primo Inserito (Effettivo)

27 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 297/SR/25

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .