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

NCT07583576 | Not Yet Recruiting

• 2 other identifiers: MPU-FES-2026-05MPU-FES-RCT-2026
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injury; Paraplegia; Spasticity; Neurorehabilitation

Keywords

Spinal Cord Injury; Paraplegia Rehabilitation; Neurorehabilitation; Spasticity; Paraplegia

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Week 8

• 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.

  Baseline and Week 8

• 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.

  Baseline and Week 8

Secondary Outcomes (4)

• Functional Independence (SCIM subdomains)

  Baseline and Week 8

• Walking Performance

  Baseline and Week 8

• Functional Mobility Performance

  Baseline and Week 8

• Spasticity Severity

  Baseline and Week 8

Study Arms (2)

Control Group - Conventional Rehabilitation

ACTIVE COMPARATOR

Participants in this arm will receive a standard neurorehabilitation program for paraplegia secondary to spinal cord injury. The program will include stretching exercises, progressive strengthening exercises, balance training, and transfer training. Sessions will be conducted 3 days per week, 45-60 minutes per session, for a total duration of 8 weeks. No Functional Electrical Stimulation (FES) will be applied in this group.

Other: Conventional Neurorehabilitation

FES + Conventional Rehabilitation Group

EXPERIMENTAL

Participants in this arm will receive the same standard neurorehabilitation program as the control group, including stretching, strengthening, balance, and transfer training (3 days per week, 45-60 minutes per session for 8 weeks). In addition, Functional Electrical Stimulation (FES) will be applied to the quadriceps femoris muscle. FES parameters will include 35 Hz frequency, 300 µs pulse duration, and a 10-second on / 20-second off cycle. FES will be administered 5 days per week for 8 weeks to facilitate neuromuscular activation, improve muscle strength, and reduce spasticity.

Device: Functional Electrical Stimulation (FES) of Quadriceps Muscle

Interventions

Conventional Neurorehabilitation OTHER

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.

Control Group - Conventional Rehabilitation

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.

FES + Conventional Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included in the study if they meet all of the following criteria:
• 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
• Presence of lower extremity spasticity (Modified Ashworth Scale ≥ 1)
• Ability to understand and follow simple instructions
• Willingness to participate and provide informed consent

You may not qualify if:

• Participants will be excluded if they present any of the following conditions:
• 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
• Dermatological conditions or open wounds preventing FES application
• History of severe autonomic dysreflexia triggered by electrical stimulation
• Uncontrolled medical conditions that may interfere with participation or safety

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Central Study Contacts

Mehmet Salih TAN, Doctorate

CONTACT

+905467266876; mstan@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation to reduce assessment bias. Participants and care providers will not be blinded due to the nature of the intervention (FES application).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Istanbul Medipol University

Model Details: Participants will be randomly assigned to one of two parallel groups: a control group receiving conventional neurorehabilitation and an intervention group receiving Functional Electrical Stimulation (FES) in addition to conventional rehabilitation. Outcomes will be compared between groups after an 8-week intervention period. No crossover will occur between groups.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 13, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL