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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Pakistan
Lahore University of Biological and Applied sciences
RECRUITING
Lahore
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2026-03-10
Participants
Target number of participants: 70
Treatments
Experimental: Experimental: Hybrid FES-AR Gait Training
Hybrid Functional Electrical Stimulation (FES) combined with Augmented Reality (AR) delivers a technology-enhanced gait rehabilitation program for individuals with incomplete spinal cord injury (SCI). FES provides timed electrical activation of lower-limb muscles-including quadriceps, hamstrings, tibialis anterior, and gastrocnemius-synchronized with gait phases to improve muscle recruitment and neuroplasticity. Concurrently, AR overlays real-time visual cues for foot placement, step length, and gait symmetry, supporting motor learning and postural control. Sessions are delivered for 30 minutes, three times per week, over eight weeks, with stimulation parameters individually adjusted for tolerance and functional response.
Active_comparator: Active Comparator: Conventional Overground Gait Training (COGT)
Conventional Overground Gait Training (COGT) is a standard physiotherapy approach used to improve gait performance in individuals with incomplete SCI. Training includes supervised overground walking with visual feedback provided through mirrors or video recordings to support self-correction of gait deviations. Therapy emphasizes step initiation, stride length, cadence, posture, and gait symmetry. Sessions last 30 minutes, three times per week, for eight weeks, conducted under standardized clinical supervision without the use of electrical stimulation or augmented-reality-based visual cues.
Sponsors
Leads: Lahore University of Biological and Applied Sciences

This content was sourced from clinicaltrials.gov