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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorLahore University of Biological and Applied Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional Electrical Stimulation (FES) and Augmented Reality (AR)

    Device

    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 placement, and gait symmetry, engaging cognitive and neuromuscular pathways to enhance motor learning and spatial awareness. Participants will undergo 30-minute sessions, three times per week, for eight weeks, with stimulation parameters (pulse width 200-400 μs, frequency 30-50 Hz, individualized intensity) tailored to tolerance. This hybrid approach distinguishes itself from conventional training by combining direct neuromuscular activation to optimize gait recovery in incomplete SCI.

  • Conventional Overground Gait Training (COGT)

    Other intervention

    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 will last 30 minutes, three times per week, for eight weeks under standardized clinical supervision. Unlike technology-assisted interventions, COGT relies on voluntary muscle activation and therapist-guided corrections without electrical stimulation or augmented reality cues.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Experimental: Hybrid FES-AR Gait TrainingExperimental treatment 1 intervention
Group B: Active Comparator: Conventional Overground Gait Training (COGT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Step Length (cm) Measured by JAKC Observational Gait Analysis

Step length will be measured in centimeters using the JAKC Observational Gait Analysis. The value represents the distance between initial contact of one foot and the subsequent initial contact of the opposite foot. Data will be reported as mean change from baseline to 8 weeks.

Time frame
8 weeks
2

Change in Stride Length (cm) Measured by JAKC Observational Gait Analysis

Stride length will be quantified in centimeters as the distance between successive initial contacts of the same foot.

Time frame
8 weeks
3

Change in Cadence (steps/min) Assessed by JAKC Observational Gait Analysis

Cadence will be measured as the number of steps taken per minute during a standardized walking trial.

Time frame
8 weeks
4

Change in Gait Symmetry Ratio (unitless) Using JAKC Observational Gait Analysis

Gait symmetry will be assessed using a symmetry ratio calculated from left and right step parameters. Lower values indicate greater symmetry.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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