Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia (FES-PAR-RCT)

May 15, 2026 updated by: salih tan, Istanbul Medipol University Hospital

Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Spinal cord injury (SCI) is a major cause of long-term disability worldwide, often resulting in paraplegia when the thoracic, lumbar, or sacral spinal segments are affected. Individuals with paraplegia commonly experience significant impairments in voluntary motor control, muscle weakness, spasticity, and reduced functional mobility, all of which contribute to decreased independence in activities of daily living.

Spasticity, defined as a velocity-dependent increase in muscle tone due to hyperexcitability of the stretch reflex, is one of the most frequent complications following upper motor neuron lesions. Although spasticity may occasionally contribute to functional stability, excessive spasticity often interferes with voluntary movement, gait training, and rehabilitation outcomes (Pandyan et al., 2005).

Functional Electrical Stimulation (FES) is a neurorehabilitation technique that delivers electrical impulses to peripheral nerves to evoke functional muscle contractions. It facilitates neuromuscular re-education, enhances motor unit recruitment, and may promote neuroplasticity in the central nervous system. Previous studies have demonstrated that FES can improve muscle strength, walking ability, and functional independence in individuals with neurological impairments (Sheffler & Chae, 2007; Kesar et al., 2010; Hesse et al., 2003).

This study is designed as a prospective, single-center, parallel-group, randomized controlled trial conducted in accordance with CONSORT 2010 guidelines. A total of 60 participants with paraplegia secondary to spinal cord injury will be enrolled and randomly allocated into two groups:

Control Group: Standard neurorehabilitation program only Intervention Group: Standard neurorehabilitation program + FES applied to the quadriceps femoris muscle The rehabilitation program will be conducted 3 days per week for 8 weeks and will include stretching exercises, strengthening exercises, balance training, and transfer training. In the intervention group, FES will be applied 5 days per week for 8 weeks with the following parameters: 35 Hz frequency, 300 µs pulse duration, and 10 seconds on / 20 seconds off cycle.

Outcome assessments will be performed at baseline (week 0) and after intervention (week 8). Spasticity will be evaluated using the Modified Ashworth Scale (MAS), which is widely used in clinical practice for assessing muscle tone in neurological conditions. Quadriceps muscle strength will be measured using Manual Muscle Testing (MMT) based on the Medical Research Council (MRC) scale. Functional mobility and independence will be assessed using SCIM, TUG, and 6MWT.

SCIM is a validated scale specifically developed for individuals with spinal cord injury and assesses self-care, respiration and sphincter management, and mobility domains. TUG test provides an objective measure of functional mobility and fall risk, while 6MWT evaluates functional exercise capacity and endurance.

The primary hypothesis of this study is that FES combined with conventional rehabilitation will significantly reduce spasticity, improve quadriceps muscle strength, and enhance functional mobility compared to conventional rehabilitation alone.

The results of this study are expected to contribute to the evidence base regarding the clinical effectiveness of FES in neurorehabilitation and may support its integration into standard rehabilitation protocols for individuals with paraplegia.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group - Conventional Rehabilitation
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
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.
Experimental: FES + Conventional Rehabilitation Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity Level
Time Frame: Baseline and Week 8
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
Time Frame: Baseline and Week 8
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
Time Frame: Baseline and Week 8

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence (SCIM subdomains)
Time Frame: Baseline and Week 8
Changes in self-care, respiration/sphincter management, and mobility domains of SCIM will be analyzed separately.
Baseline and Week 8
Walking Performance
Time Frame: Baseline and Week 8
Total distance walked in 6 minutes (meters). Increased distance indicates improved functional endurance
Baseline and Week 8
Functional Mobility Performance
Time Frame: Baseline and Week 8
Time required (seconds) to stand up, walk 3 meters, turn, return, and sit down. Lower time indicates improved mobility.
Baseline and Week 8
Spasticity Severity
Time Frame: Baseline and Week 8
Comparison of spasticity reduction between intervention and control groups.
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPU-FES-2026-05
  • MPU-FES-RCT-2026 (Other Identifier: Istanbul Medipol University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The fully anonymized individual participant data (IPD) obtained in this study will be shared with appropriate researchers upon reasonable request following the publication of primary results. Data sharing will be carried out in accordance with institutional ethics committee regulations and applicable data protection laws.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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