Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCasa Colina Hospital and Centers for Healthcare

About this trial

People with neurological conditions often have difficulty walking, including problems such as foot drop. Functional electrical stimulation (FES) is a treatment that uses electrical signals to activate muscles and support walking. The L300 device is designed to help lift the foot during each step.

This study will evaluate how using the L300 affects walking performance. Researchers will measure walking speed, step length, and walking symmetry using objective gait assessment tools. The study will also explore whether people with different neurological conditions respond differently to FES.

The goal of this research is to improve understanding of how FES influences walking and to support more personalized rehabilitation approaches.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-80 years.

Diagnosis of stroke, traumatic brain injury, or multiple sclerosis confirmed by medical records.

Presence of foot drop or impaired ankle dorsiflexion during gait.

Ability to ambulate at least 10 meters with or without assistive devices.

Disqualifiers

Severe lower limb contractures or orthopedic conditions that limit gait.

Implanted electrical devices (e.g., pacemaker) contraindicating FES use.

Uncontrolled medical conditions (e.g., severe cardiac disease).

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional Electrical Stimulation

    Device

    Functional Electrical Stimulation (FES) is an established therapeutic approach that applies electrical currents to peripheral nerves to elicit muscle contractions, thereby facilitating movement in individuals with neurological impairments. FES has demonstrated benefits for improving motor function and gait in populations such as stroke survivors, individuals with spinal cord injury, and those with multiple sclerosis. By activating muscles during walking, FES can enhance gait parameters including speed, stride length, and symmetry, ultimately supporting greater independence and mobility.

  • Normal care

    Device

    No device, no FES

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: FESExperimental treatment 1 intervention
Group B: FES - RCTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Changes in gait speed

Measuring changes in gait speed

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Timed Up and Go

The Timed Up and Go test measures basic mobility and balance. Participants start seated in a chair, stand up, walk a short distance (3 meters), turn around, walk back to the chair, and sit down. The time it takes to complete the task is recorded in seconds. Shorter times indicate better mobility and functional walking ability.

Time frame
Baseline and 12-week Follow-Up
2

10-Meter Walk Test

The 10-Meter Walk Test measures walking speed over a short distance. Participants are asked to walk 10 meters at their normal walking pace. The time to walk the distance is recorded and used to calculate walking speed. Faster walking speeds indicate better walking ability.

Time frame
Baseline and 12-Week Follow-Up

Other outcomes

Sponsors and contacts

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