Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul Medipol University Hospital

About this trial

Spinal cord injury (SCI)-related paraplegia is a complex neurological condition characterized by motor impairment, increased spasticity, and significant functional limitations in daily activities. Spasticity is one of the most common secondary complications after upper motor neuron lesions and can negatively affect rehabilitation outcomes, gait ability, and functional independence.

This randomized controlled study aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Participants will be randomly assigned to either a control group receiving conventional neurorehabilitation or an intervention group receiving additional FES treatment.

The primary outcomes include changes in spasticity level, quadriceps muscle strength, and functional mobility. Spasticity will be assessed using the Modified Ashworth Scale (MAS), muscle strength will be evaluated with Manual Muscle Testing (MMT), and functional mobility will be measured using the Spinal Cord Independence Measure (SCIM), Timed Up and Go Test (TUG), and 6-Minute Walk Test (6MWT).

The intervention period will last 8 weeks, with standardized rehabilitation programs applied to both groups. The FES group will additionally receive quadriceps stimulation with specific neuromuscular electrical stimulation parameters.

The findings of this study are expected to provide evidence regarding the effectiveness of FES as an adjunct to conventional rehabilitation in improving motor function and functional independence in individuals with paraplegia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 65 years

Diagnosed with spinal cord injury resulting in paraplegia (traumatic or non-traumatic etiology)

Classified as ASIA Impairment Scale C or D

Medically stable condition

Disqualifiers

Presence of cardiac pacemaker or implanted electrical device

Severe cognitive impairment or communication difficulties preventing participation

Active infection or systemic inflammatory condition

Severe lower extremity contractures or deformities limiting movement

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Neurorehabilitation

    Other intervention

    This intervention consists of a conventional neurorehabilitation program designed for individuals with paraplegia secondary to spinal cord injury. The program includes stretching exercises, progressive strengthening exercises, balance training, and transfer training. Sessions are conducted 3 days per week, 45-60 minutes per session, over a total duration of 8 weeks. This group does not receive Functional Electrical Stimulation (FES). The intervention is aimed at improving general motor function, maintaining joint range of motion, and enhancing functional independence.

  • Functional Electrical Stimulation (FES) of Quadriceps Muscle

    Device

    This intervention consists of Functional Electrical Stimulation (FES) applied to the quadriceps femoris muscle in addition to the same conventional neurorehabilitation program provided to the control group. FES is delivered using a neuromuscular electrical stimulation device to induce muscle contractions via peripheral nerve activation. Stimulation parameters include 35 Hz frequency, 300 µs pulse duration, and a 10-second on / 20-second off cycle. The intervention is applied 5 days per week for 8 weeks. The aim is to enhance neuromuscular activation, reduce spasticity, increase quadriceps muscle strength, and improve functional mobility in individuals with paraplegia.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control Group - Conventional RehabilitationActive comparator 1 intervention
Group B: FES + Conventional Rehabilitation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Spasticity Level

Spasticity will be assessed using the Modified Ashworth Scale (MAS), which grades muscle tone from 0 to 4. Higher scores indicate increased spasticity. The primary comparison will be the change in MAS scores between baseline and after 8 weeks of intervention.

Time frame
Baseline and Week 8
2

Quadriceps Muscle Strength

Muscle strength will be evaluated using Manual Muscle Testing (MMT) based on the Medical Research Council (MRC) scale (0-5). Higher scores indicate greater muscle strength.

Time frame
Baseline and Week 8
3

Functional Mobility

Functional mobility will be assessed using: Spinal Cord Independence Measure (SCIM) Timed Up and Go Test (TUG) 6-Minute Walk Test (6MWT) SCIM evaluates independence in daily activities, TUG assesses functional mobility and fall risk, and 6MWT measures walking capacity and endurance. Improvements indicate better functional mobility.

Time frame
Baseline and Week 8

Secondary outcomes

1

Functional Independence (SCIM subdomains)

Changes in self-care, respiration/sphincter management, and mobility domains of SCIM will be analyzed separately.

Time frame
Baseline and Week 8
2

Walking Performance

Total distance walked in 6 minutes (meters). Increased distance indicates improved functional endurance

Time frame
Baseline and Week 8
3

Functional Mobility Performance

Time required (seconds) to stand up, walk 3 meters, turn, return, and sit down. Lower time indicates improved mobility.

Time frame
Baseline and Week 8
4

Spasticity Severity

Comparison of spasticity reduction between intervention and control groups.

Time frame
Baseline and Week 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: