Spinal Cord InjuryFES-PAR-RCTNCT07583576
Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia
A study testing Conventional Neurorehabilitation and Functional Electrical Stimulation (FES) of Quadriceps Muscle in people with Spinal Cord Injury and Paraplegia, run by Istanbul Medipol University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Paraplegia, Spasticity
- What is being tested?
- Conventional Neurorehabilitation and Functional Electrical Stimulation (FES) of Quadriceps Muscle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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. Brief Summary
Read more
This randomized controlled trial aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Individuals included in the study will be divided into three groups: control group, FES application group, and Sham group. The control group will receive only a standard neurological rehabilitation program, while the FES group will receive Functional Electrical Stimulation to the quadriceps muscle in addition to the FES program. The Sham FES group will receive Conventional neurorehabilitation + sham/placebo FES.
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.
Read the 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 three groups:
Control Group: Standard neurorehabilitation program only Intervention Group: Standard neurorehabilitation program + FES applied to the quadriceps femoris muscle Sham FES group : The group will receive Conventional neurorehabilitation + sham/placebo FES.
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.
- Conditions
- Spinal Cord Injury, Paraplegia, Spasticity, Neurorehabilitation
- Being tested
- Conventional Neurorehabilitation, Functional Electrical Stimulation (FES) of Quadriceps Muscle, Sham FES group: Conventional neurorehabilitation + sham/placebo FES
- Keywords
- Spinal Cord Injury, Paraplegia Rehabilitation, Neurorehabilitation, Spasticity, Paraplegia
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional NeurorehabilitationOther
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 MuscleDevice
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.
Sham FES group: Conventional neurorehabilitation + sham/placebo FESDevice
Sham FES group: Conventional neurorehabilitation + sham/placebo FES In the Sham group, the electrodes are placed in the same way; the device is operated at low intensity for a short time and then turned off so as not to create effective muscle contraction or kept at a minimal sensory level. The aim is to maintain the patient's feeling of "practicing", but not to create a therapeutic FES effect. Sham-controlled design is a powerful method used to reduce the placebo effect in electrical stimulation studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Neurorehabilitation; Device: Functional Electrical Stimulation (FES) of Quadriceps Muscle |
| Sham FES Group | Sham comparator | Sham FES group: Conventional neurorehabilitation + sham/placebo FES In the Sham group, the electrodes are placed in the same way; the device is operated at low intensity for a short time and then turned off so as not to create effective muscle contraction or kept at a minimal sensory level. The aim is to maintain the patient's feeling of "practicing", but not to create a therapeutic FES effect. Sham-controlled design is a powerful method used to reduce the placebo effect in electrical stimulation studies Receives: Other: Conventional Neurorehabilitation; Device: Sham FES group: Conventional neurorehabilitation + sham/placebo FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Secondary outcomes (4)
Functional Independence (SCIM subdomains)
Changes in self-care, respiration/sphincter management, and mobility domains of SCIM will be analyzed separately.
Measured: Baseline and Week 8
Walking Performance
Total distance walked in 6 minutes (meters). Increased distance indicates improved functional endurance
Measured: Baseline and Week 8
Functional Mobility Performance
Time required (seconds) to stand up, walk 3 meters, turn, return, and sit down. Lower time indicates improved mobility.
Measured: Baseline and Week 8
Spasticity Severity
Comparison of spasticity reduction between intervention and control groups.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start10 May 2026
- Primary completion10 Jun 2026
- Study completion10 Jul 2026
Why it stopped: The study was discontinued due to the relocation of the investigator responsible for its conduct and related logistical constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The individuals included in the study will be divided into three groups: control group, FES practice group and Sham Group. While only the standard neurological rehabilitation program is applied to the control group, Functional Electrical Stimulation will be applied to the quadriceps muscle in addition to the FES group. Conventional neurorehabilitation to Sham FES group + sham/placebo FES Outcomes will be compared between groups after an 8-week intervention period. No crossover will occur between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salih tan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583576
- Sponsor's protocol ID
- MPU-FES-2026-05
- Other IDs
- MPU-FES-RCT-2026
- Acronym
- FES-PAR-RCT
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07583576
- Acronym / sponsor ID
- FES-PAR-RCT / MPU-FES-2026-05
- Conditions
- Spinal Cord Injury, Paraplegia, Spasticity, Neurorehabilitation
- Keywords
- Spinal Cord Injury, Paraplegia Rehabilitation, Neurorehabilitation, Spasticity, Paraplegia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was discontinued due to the relocation of the investigator responsible for its conduct and related logistical constraints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Brief Summary
This randomized controlled trial aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Individuals included in the study will be divided into three groups: control group, FES application group, and Sham group. The control group will receive only a standard neurological rehabilitation program, while the FES group will receive Functional Electrical Stimulation to the quadriceps muscle in addition to the FES program. The Sham FES group will receive Conventional neurorehabilitation + sham/placebo FES.
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.
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 three groups:
Control Group: Standard neurorehabilitation program only Intervention Group: Standard neurorehabilitation program + FES applied to the quadriceps femoris muscle Sham FES group : The group will receive Conventional neurorehabilitation + sham/placebo FES.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The individuals included in the study will be divided into three groups: control group, FES practice group and Sham Group. While only the standard neurological rehabilitation program is applied to the control group, Functional Electrical Stimulation will be applied to the quadriceps muscle in addition to the FES group. Conventional neurorehabilitation to Sham FES group + sham/placebo FES Outcomes will be compared between groups after an 8-week intervention period. No crossover will occur between groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group - Conventional Rehabilitation | Active comparator | Other: Conventional NeurorehabilitationParticipants 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. |
| FES + Conventional Rehabilitation Group | Experimental | Other: Conventional Neurorehabilitation, Device: Functional Electrical Stimulation (FES) of Quadriceps MuscleParticipants 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. |
| Sham FES Group | Sham comparator | Other: Conventional Neurorehabilitation, Device: Sham FES group: Conventional neurorehabilitation + sham/placebo FESSham FES group: Conventional neurorehabilitation + sham/placebo FES In the Sham group, the electrodes are placed in the same way; the device is operated at low intensity for a short time and then turned off so as not to create effective muscle contraction or kept at a minimal sensory level. The aim is to maintain the patient's feeling of "practicing", but not to create a therapeutic FES effect. Sham-controlled design is a powerful method used to reduce the placebo effect in electrical stimulation studies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional NeurorehabilitationThis 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. | Other | Control Group - Conventional Rehabilitation, FES + Conventional Rehabilitation Group, Sham FES Group |
| Functional Electrical Stimulation (FES) of Quadriceps MuscleThis 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. | Device | FES + Conventional Rehabilitation Group |
| Sham FES group: Conventional neurorehabilitation + sham/placebo FESSham FES group: Conventional neurorehabilitation + sham/placebo FES In the Sham group, the electrodes are placed in the same way; the device is operated at low intensity for a short time and then turned off so as not to create effective muscle contraction or kept at a minimal sensory level. The aim is to maintain the patient's feeling of "practicing", but not to create a therapeutic FES effect. Sham-controlled design is a powerful method used to reduce the placebo effect in electrical stimulation studies | Device | Sham FES Group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Functional Independence (SCIM subdomains)
Time frame: Baseline and Week 8
Walking Performance
Time frame: Baseline and Week 8
Functional Mobility Performance
Time frame: Baseline and Week 8
Spasticity Severity
Time frame: Baseline and Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Neurorehabilitation and Functional Electrical Stimulation (FES) of Quadriceps Muscle in people with Spinal Cord Injury and Paraplegia, run by Istanbul Medipol University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity Level (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.