Effect of Hybrid Functional Electrical Stimulation and Augmented Reality-Based Gait Training on Gait Parameters Among Incomplete Spinal Cord Injury Patients
NCT07263581 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-01-15
Summary
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.
Conditions
- Incomplete Spinal Cord Injury (SCI)
- ASIA C and D Classification of SCI
- Gait Dysfunction
Interventions
- DEVICE
-
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 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.
- OTHER
-
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 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.
Sponsors & Collaborators
-
Lahore University of Biological and Applied Sciences
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-10
- Primary Completion
- 2026-02-10
- Completion
- 2026-03-10
Countries
- Pakistan
Study Locations
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