Effect of Hybrid Functional Electrical Stimulation and Augmented Reality-Based Gait Training on Gait Parameters Among Incomplete Spinal Cord Injury Patients

Обзор

The goal of this clinical trial is to determine whether combining Functional Electrical Stimulation (FES) with Augmented Reality (AR)-based gait training can improve walking ability in individuals with incomplete spinal cord injury (SCI). The study aims to identify the most effective rehabilitation approach for enhancing gait performance and functional independence among these patients. In this study, participants will include: * Adults aged 18-45 years * Diagnosed with incomplete spinal cord injury (ASIA Impairment Scale grades C or D) * Neurological level of injury between T10 and L2 * Medically stable and able to walk with or without assistive devices * Cognitively intact and capable of providing informed consent Exclusion Criteria: * Severe spasticity or contractures in the lower limbs * Significant pain or joint instability * Other neurological or musculoskeletal disorders (e.g., stroke, multiple sclerosis) * Recent lower limb fractures or orthopedic surgeries * Cardiovascular instability or open skin lesions Two treatment groups will be formed: Group A and Group B. * Group A will receive Hybrid FES-AR gait training, which combines electrical stimulation of muscles with visual, task-specific feedback provided through augmented reality. * Group B will receive conventional gait training, which includes standard physiotherapy methods such as strength, balance, and mobility exercises without FES or AR. Both interventions will be delivered over 12 weeks, with 3 sessions per week, each lasting approximately 40 minutes. Baseline assessments will be conducted before starting therapy, followed by evaluations at 6 weeks and 12 weeks. The outcome measures will include improvements in gait speed, step length, stride length, cadence, and gait symmetry, using validated clinical tools such as the JAKC Observational Gait Analysis, Walking Index for Spinal Cord Injury II (WISCI II), and the Functional Gait Assessment (FGA). This study seeks to determine whether the hybrid approach (FES + AR) leads to greater improvement in walking ability compared to traditional gait training. The findings may help guide future rehabilitation strategies and support the integration of technology-based interventions into spinal cord injury management.

Подробное описание

Spinal cord injury (SCI) is a debilitating neurological condition characterized by varying degrees of motor and sensory impairment below the level of injury. Individuals with incomplete SCI, particularly those classified as ASIA Impairment Scale (AIS) Grades C and D, retain partial voluntary motor function and therefore demonstrate significant potential for neurological and functional recovery. Despite this capacity, gait abnormalities such as reduced step length, altered cadence, asymmetrical stride, and impaired balance remain common, contributing to limitations in independence, mobility, and quality of life. Enhancing gait performance in this population requires rehabilitation strategies that support neuroplasticity, promote motor relearning, and provide sufficient sensory feedback.

Functional Electrical Stimulation (FES) is an established modality used to generate controlled muscle contractions by stimulating peripheral motor nerves. In individuals with incomplete SCI, FES assists with activating essential lower limb muscle groups; including the quadriceps, hamstrings, and tibialis anterior, to improve joint motion, stabilize limb control, and facilitate gait-related movement patterns. The stimulation also contributes to strengthening neuromuscular pathways necessary for functional ambulation.

Augmented Reality (AR) provides an interactive rehabilitation environment in which digital visual cues are superimposed onto real-world tasks to guide posture, limb placement, cadence, and motor control. AR-based gait training enhances sensorimotor feedback, increases patient engagement, and allows real-time correction of movement deviations. For individuals with incomplete SCI, this feedback facilitates task-specific motor retraining during walking.

The integration of FES with AR-based gait training represents a hybrid approach that simultaneously targets neuromuscular activation and sensorimotor learning. This combined intervention is designed to optimize spatiotemporal gait mechanics by providing synchronized electrical stimulation and visual feedback during repetitive walking tasks. The protocol focuses on muscle groups critical for locomotion at the T10-L2 neurological levels, where preservation of hip flexors, quadriceps, and ankle dorsiflexors plays a central role in functional gait recovery.

This randomized controlled trial will compare the effectiveness of hybrid FES-AR gait training with conventional overground gait training. The intervention follows a structured schedule across an 8-week period, using standardized procedures to ensure consistency across participants. Outcomes will be assessed using validated tools capable of identifying changes in gait quality, symmetry, efficiency, and functional walking capacity. The trial will evaluate improvements in gait speed, step and stride length, cadence, and symmetry to determine whether the hybrid intervention produces superior outcomes relative to traditional physiotherapy approaches.

The findings from this study are expected to contribute to evidence-based advancements in neurorehabilitation by determining whether technology-assisted gait training provides measurable benefits for individuals with incomplete SCI.

Вмешательства

• Устройство Functional Electrical Stimulation (FES) and Augmented Reality (AR)
  Functional Electrical Stimulation (FES) combined with Augmented Reality (AR) provides an advanced gait rehabilitation approach for individuals with incomplete spinal cord injury (SCI). FES uses controlled electrical currents to activate key lower-limb muscles-including quadriceps, hamstrings, tibialis anterior, and gastrocnemius-synchronized with gait phases via sensor-driven systems, promoting strength, coordination, and neuroplasticity. AR delivers real-time visual cues for step length, foot p
• Другое Conventional Overground Gait Training (COGT)
  Conventional Overground Gait Training (COGT) is a standard physiotherapy approach for improving walking ability in individuals with incomplete spinal cord injury (SCI). In this study, participants in the control group will perform walking exercises over ground, guided by a therapist, with visual feedback provided through mirrors or video observation. Training will focus on step initiation, stride length, cadence, and gait symmetry, emphasizing proper posture and safe weight shifting. Sessions wi

Первичные конечные точки

• Change in Step Length (cm) Measured by JAKC Observational Gait Analysis [Срок оценки: 8 weeks]
• Change in Stride Length (cm) Measured by JAKC Observational Gait Analysis [Срок оценки: 8 weeks]
• Change in Cadence (steps/min) Assessed by JAKC Observational Gait Analysis [Срок оценки: 8 weeks]
• Change in Gait Symmetry Ratio (unitless) Using JAKC Observational Gait Analysis [Срок оценки: 8 weeks]
• Walking Index for Spinal Cord Injury II (WISCI II) [Срок оценки: 8 weeks]
• Functional Gait Assessment (FGA) [Срок оценки: 8 weeks]
• Step Length (centimeters) [Срок оценки: 8 weeks]
• Stopwatch 10-Meter Walk Test (10MWT) Gait Speed (meters/second) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Diagnosed with incomplete spinal cord injury (ASIA Impairment Scale C or D)
• Neurological level of injury between T10 and L2
• Aged 18 to 45 years
• Medically stable with no acute complications
• Able to walk with or without assistive devices
• Cognitively intact
• Capable of providing written informed consent
• Stable physical and emotional health
• No history of seizures
• No major urinary or bowel dysfunction

Критерии исключения

• Severe spasticity or contractures in the lower limbs
• Significant pain or joint instability in the lower limbs
• Presence of other neurological (e.g., stroke, multiple sclerosis) or musculoskeletal disorders
• Open skin lesions or ulcerations
• History of fractures or orthopedic surgery in the lower limbs
• Severe cardiovascular conditions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Lahore University of Biological and Applied sciences — Lahore

Идентификаторы

NCT: NCT07263581 · UBS24LMSPT012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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