Incomplete Spinal Cord Injury (SCI)FES-SCINCT07645144
FES-assisted Gait Training for Incomplete Spinal Cord Injury
A study testing FES-assisted gait training in people with Incomplete Spinal Cord Injury (SCI) and SCI - Spinal Cord Injury, run by Stichting Reade at 1 site in Netherlands.
Trial summary
Spinal cord injuries (SCI) impair neural communication, leading to difficulties in walking due to muscle weakness, altered reflexes, and impaired muscle activation below the injury. Read more about this study
- Who is it for?
- Ages 17 to 85 years
- Conditions the study is for
- Incomplete Spinal Cord Injury (SCI), SCI - Spinal Cord Injury
- What is being tested?
- FES-assisted gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a non-progressive chronic (>1 yrs) incomplete SCI between C4 and T12 with an ASIA score of C or D.
- Be at least 18 years of age.
- Be able to take some steps (with assistive devices or in the bridge).
- As part of the inclusion process, responsiveness to electrical stimulation will be assessed using a Compex electrical stimulator (Compex SP 4.0; Compex Medical SA, Switzerland) to ensure potential participant's respond well to ES, and to ensure that the sensitivity threshold is not reached before motor response in all target muscles.
Who cannot join
- Flaccid paralysis.
- Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training.
- Botox injections in the lower extremities during the last six months.
- Women who are (planning to get) pregnant during the study period.
- Implanted neurostimulator or stimulator of any kind that can have an influence on the safe use of ES.
- Pacemaker, or other device, present in the body that prevents the safe use of ES.
Show all 9Show fewer
- Inability to communicate well or have cognitive disorders.
- Currently being enrolled in another training study or participated in a training study in the previous six months.
- Having an illness that has a high chance of preventing them to be able to perform the training at a sufficient frequency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Automated Multi-channel Closed-loop Functional Electrical Stimulation Assisted Gait to Improve Gait in People With Incomplete Spinal Cord Injury
Spinal cord injuries (SCI) impair neural communication, leading to difficulties in walking due to muscle weakness, altered reflexes, and impaired muscle activation below the injury. Functional electrical stimulation (FES) has been shown to enhance voluntary control, strength, and walking performance when used during gait training. This study aims to assess whether the FES yields superior improvements in walking ability compared to conventional gait training without stimulation.
Read the detailed description
Background:
Spinal cord injury (SCI) disrupts neural communication, resulting in impaired walking ability due to muscle weakness, altered reflex modulation, and reduced voluntary muscle activation below the lesion level. Functional electrical stimulation (FES) applied during gait training has been shown to enhance muscle activation and improve gait performance. However, it remains unclear whether gait training with automated multi-channel FES provides additional benefits beyond conventional treadmill gait training in individuals with chronic incomplete SCI (iSCI).
Objectives:
(1) To determine whether gait training combined with FES leads to greater improvements in overground walking speed compared to improvements observed during the preceding period of conventional gait training alone. (2) To evaluate retention of walking improvements following the FES intervention. (3) To explore whether changes in gait performance are associated with changes in muscle coordination and muscle strength.
Methods:
This study is a prospective single-group, repeated-measures study with two sequential intervention phases: 10 weeks of conventional treadmill gait training followed by 10 weeks of gait training with FES. Individuals with chronic iSCI (≥12 months post-injury; AIS C or D; neurological level C2-T12) will participate in a 23-week program. Assessments will be performed at baseline (T0), after conventional training (T1), after FES gait training (T2), and at 10-weeks post intervention (T3). The primary outcome is the 10-Meter Walk Test (10MWT) walking speed (m/s). The primary analysis compares the change in 10MWT performance during the FES-assisted phase (T2-T1) with the change during the conventional phase (T1-T0). Secondary outcomes include spatiotemporal gait parameters, Walking Index for Spinal Cord Injury II, Hoffer classification, treadmill gait performance, muscle activity, and isometric leg muscle strength.
- Being tested
- FES-assisted gait training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-assisted gait trainingOther
Following completion of the conventional training phase, participants continue with 20 sessions of gait training combined with FES. Training frequency, duration, and treadmill procedures remain identical to the conventional training phase, including the use of the safety harness system and the option for seated breaks during walking. During sessions, participants wear the trousers part of a full-body garment (Teslasuit, Deep Divers, London, UK), which delivers FES through integrated textile electrodes positioned over the target muscle groups.
| Study group | Role | What they receive |
|---|---|---|
| Conventional gait training | Other | Conventional gait training serves as the comparator condition and is performed without FES. Training is performed on a motorized treadmill, twice per week. Participants are secured in a safety harness system to prevent falls. Body-weight support may be provided with the minimum level of support determined during the first session and kept constant throughout the training period. Participants hold the treadmill handrails for balance support but are instructed not to use them for weight bearing. The initial treadmill speed is set to match the comfortable walking speed recorded during the baseline 10MWT. Speed may be adjusted during training according to the participants' walking capacity and safety considerations. If a participant is unable to complete the 10MWT, an appropriate starting speed will be estimated by the supervising physiotherapist/researcher. Receives: Other: FES-assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
The primary outcome is walking speed (m/s) on the 10MWT, assessed at T0, T1, T2, and T3. The primary analysis compares the change during the FES-assisted phase (T2-T1) with the change during the conventional phase (T1-T0). If a participant cannot complete the full 10 meters, the trial is excluded from the primary analysis and recorded as missing data
Measured: From enrollment to the end of study at 33 weeks
Secondary outcomes (13)
Spatiotemporal gait parameters - step length
Step length (cm) will be assessed during the 10MWT using a markerless 3D full-body motion registration system (the Interactive Walkway; four Microsoft Kinect v2 sensors, 30Hz; Geerse et al., 2015). The gait parameters will be determined between the 2 and 8-meter line on the walkway to reduce the effect of gait acceleration and deceleration.
Measured: From enrollment to the end of study at 33 weeks
Spatiotemporal gait parameters - step width
Step width (cm) will be assessed during the 10MWT using a markerless 3D full-body motion registration system (the Interactive Walkway; four Microsoft Kinect v2 sensors, 30Hz; Geerse et al., 2015). The gait parameters will be determined between the 2 and 8-meter line on the walkway to reduce the effect of gait acceleration and deceleration.
Measured: From enrollment to the end of study at 33 weeks
Spatiotemporal gait parameters - Cadence
Cadence (steps/min) will be assessed during the 10MWT using a markerless 3D full-body motion registration system (the Interactive Walkway; four Microsoft Kinect v2 sensors, 30Hz; Geerse et al., 2015). The gait parameters will be determined between the 2 and 8-meter line on the walkway to reduce the effect of gait acceleration and deceleration.
Measured: From enrollment to the end of study at 33 weeks
Functional ambulation - WISCI II
Evaluated at T0, T1, T2, and T3 using the WISCI II (0-20).
Measured: From enrollment to the end of study at 33 weeks
Functional ambulation - Hoffer classification
Evaluated at T0, T1, T2, and T3 using the Hoffer classification (5-point scale).
Measured: From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - Center of Activity
Surface EMG (Trigno Wireless EMG System, Delsys Inc., Natick, USA) will be used to record muscle activity from eight muscles bilaterally during the 10MWTs. The muscle set comprises bilateral tibialis anterior (TA), gastrocnemius medialis (GAM), soleus (SOL), peroneus longus (PL), rectus femoris (RF), vastus lateralis (VL), gluteus maximus (GLM), and semitendinosus (ST). This selection provides a comprehensive overview of lower-limb muscle activity and is consistent with standard practices in gait research and clinical motor control studies (Agostini et al., 2020; Kotov-Smolenskiy et al., 2021). Center of Activity will be calculated for each muscle at T0, T1 and T2.
Measured: From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - full width at half maximum
Surface EMG (Trigno Wireless EMG System, Delsys Inc., Natick, USA) will be used to record muscle activity from eight muscles bilaterally during the 10MWTs. The muscle set comprises bilateral tibialis anterior (TA), gastrocnemius medialis (GAM), soleus (SOL), peroneus longus (PL), rectus femoris (RF), vastus lateralis (VL), gluteus maximus (GLM), and semitendinosus (ST). This selection provides a comprehensive overview of lower-limb muscle activity and is consistent with standard practices in gait research and clinical motor control studies (Agostini et al., 2020; Kotov-Smolenskiy et al., 2021). The full width at half maximum (FWHM) will be calculated at T0, T1 and T2.
Measured: From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - Co-contraction
Surface EMG (Trigno Wireless EMG System, Delsys Inc., Natick, USA) will be used to record muscle activity from eight muscles bilaterally during the 10MWTs. The muscle set comprises bilateral tibialis anterior (TA), gastrocnemius medialis (GAM), soleus (SOL), peroneus longus (PL), rectus femoris (RF), vastus lateralis (VL), gluteus maximus (GLM), and semitendinosus (ST). This selection provides a comprehensive overview of lower-limb muscle activity and is consistent with standard practices in gait research and clinical motor control studies (Agostini et al., 2020; Kotov-Smolenskiy et al., 2021). The Co-contraction will be calculated at T0, T1 and T2.
Measured: From enrollment to the end of study at 33 weeks
Muscle strength
Peak isometric knee extension and flexion torque (Nm) are assessed bilaterally using a load cell, with participants seated at 90° hip and knee flexion. Participants exert force against a fixed horizontal strap attached to a wall, with the force measured using the load cell. The lower leg is positioned perpendicular to the strap such that joint torque can be computed as load cell force × moment arm, where the moment arm (distance from the knee joint center to the strap attachment point on the lower leg) is measured at each trial. Three maximal trials per direction are performed; the highest value is the primary outcome and the mean of three trials is reported as a secondary consistency measure.
Measured: From enrollment to the end of study at 33 weeks
Treadmill walking performance - Distance Covered
Treadmill walking performance is monitored across all 40 training sessions. Distance covered (m) is recorded by the treadmill software at the end of each session.
Measured: During the 20 weeks training sessions
Treadmill walking performance - Walking Speed
Treadmill walking performance is monitored across all 40 training sessions. Walking speed (km/h) is recorded by the treadmill software at the end of each session.
Measured: During the 20 weeks training sessions
Treadmill walking performance - Duration
Treadmill walking performance is monitored across all 40 training sessions. Duration (min) is recorded by the treadmill software at the end of each session.
Measured: During the 20 weeks training sessions
Gait kinematics during FES-assisted gait training
Ankle and knee joint angles are recorded continuously across all 20 FES-assisted sessions using the six lower-body IMUs of the Teslasuit (femur, tibia, and foot bilaterally; 100 Hz). Raw data are stored for offline processing; all kinematic analyses are exploratory.
Measured: During the 10 week gait training with FES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 Feb 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Spinal Cord Injury (SCI)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stichting Reade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Janssen, Prof. Dr., Principal investigator, Vrije Universiteit Amsterdam / Stichting Reade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645144
- Sponsor's protocol ID
- W25.058
- Other IDs
- NL-010640
- Acronym
- FES-SCI
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Multi-channel Closed-loop Functional Electrical Stimulation Assisted Gait to Improve Gait in People With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07645144
- Acronym / sponsor ID
- FES-SCI / W25.058
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stichting ReadeUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Jun 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 injuries (SCI) impair neural communication, leading to difficulties in walking due to muscle weakness, altered reflexes, and impaired muscle activation below the injury. Functional electrical stimulation (FES) has been shown to enhance voluntary control, strength, and walking performance when used during gait training. This study aims to assess whether the FES yields superior improvements in walking ability compared to conventional gait training without stimulation.
Detailed description
Background:
Spinal cord injury (SCI) disrupts neural communication, resulting in impaired walking ability due to muscle weakness, altered reflex modulation, and reduced voluntary muscle activation below the lesion level. Functional electrical stimulation (FES) applied during gait training has been shown to enhance muscle activation and improve gait performance. However, it remains unclear whether gait training with automated multi-channel FES provides additional benefits beyond conventional treadmill gait training in individuals with chronic incomplete SCI (iSCI).
Objectives:
(1) To determine whether gait training combined with FES leads to greater improvements in overground walking speed compared to improvements observed during the preceding period of conventional gait training alone. (2) To evaluate retention of walking improvements following the FES intervention. (3) To explore whether changes in gait performance are associated with changes in muscle coordination and muscle strength.
Methods:
This study is a prospective single-group, repeated-measures study with two sequential intervention phases: 10 weeks of conventional treadmill gait training followed by 10 weeks of gait training with FES. Individuals with chronic iSCI (≥12 months post-injury; AIS C or D; neurological level C2-T12) will participate in a 23-week program. Assessments will be performed at baseline (T0), after conventional training (T1), after FES gait training (T2), and at 10-weeks post intervention (T3). The primary outcome is the 10-Meter Walk Test (10MWT) walking speed (m/s). The primary analysis compares the change in 10MWT performance during the FES-assisted phase (T2-T1) with the change during the conventional phase (T1-T0). Secondary outcomes include spatiotemporal gait parameters, Walking Index for Spinal Cord Injury II, Hoffer classification, treadmill gait performance, muscle activity, and isometric leg muscle strength.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional gait training | Other | Other: FES-assisted gait trainingConventional gait training serves as the comparator condition and is performed without FES. Training is performed on a motorized treadmill, twice per week. Participants are secured in a safety harness system to prevent falls. Body-weight support may be provided with the minimum level of support determined during the first session and kept constant throughout the training period. Participants hold the treadmill handrails for balance support but are instructed not to use them for weight bearing. The initial treadmill speed is set to match the comfortable walking speed recorded during the baseline 10MWT. Speed may be adjusted during training according to the participants' walking capacity and safety considerations. If a participant is unable to complete the 10MWT, an appropriate starting speed will be estimated by the supervising physiotherapist/researcher. |
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have a non-progressive chronic (>1 yrs) incomplete SCI between C4 and T12 with an ASIA score of C or D.
- Be at least 18 years of age.
- Be able to take some steps (with assistive devices or in the bridge).
- As part of the inclusion process, responsiveness to electrical stimulation will be assessed using a Compex electrical stimulator (Compex SP 4.0; Compex Medical SA, Switzerland) to ensure potential participant's respond well to ES, and to ensure that the sensitivity threshold is not reached before motor response in all target muscles.
Key exclusion criteria (9 listed)
- Flaccid paralysis.
- Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training.
- Botox injections in the lower extremities during the last six months.
- Women who are (planning to get) pregnant during the study period.
- Implanted neurostimulator or stimulator of any kind that can have an influence on the safe use of ES.
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 |
|---|---|---|
| FES-assisted gait trainingFollowing completion of the conventional training phase, participants continue with 20 sessions of gait training combined with FES. Training frequency, duration, and treadmill procedures remain identical to the conventional training phase, including the use of the safety harness system and the option for seated breaks during walking. During sessions, participants wear the trousers part of a full-body garment (Teslasuit, Deep Divers, London, UK), which delivers FES through integrated textile electrodes positioned over the target muscle groups. | Other | Conventional gait training |
Primary outcome
walking speed
Time frame: From enrollment to the end of study at 33 weeks
The primary outcome is walking speed (m/s) on the 10MWT, assessed at T0, T1, T2, and T3. The primary analysis compares the change during the FES-assisted phase (T2-T1) with the change during the conventional phase (T1-T0). If a participant cannot complete the full 10 meters, the trial is excluded from the primary analysis and recorded as missing data
13 secondary outcomes
Spatiotemporal gait parameters - step length
Time frame: From enrollment to the end of study at 33 weeks
Spatiotemporal gait parameters - step width
Time frame: From enrollment to the end of study at 33 weeks
Spatiotemporal gait parameters - Cadence
Time frame: From enrollment to the end of study at 33 weeks
Functional ambulation - WISCI II
Time frame: From enrollment to the end of study at 33 weeks
Functional ambulation - Hoffer classification
Time frame: From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - Center of Activity
Time frame: From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - full width at half maximum
Time frame: From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - Co-contraction
Time frame: From enrollment to the end of study at 33 weeks
Muscle strength
Time frame: From enrollment to the end of study at 33 weeks
Treadmill walking performance - Distance Covered
Time frame: During the 20 weeks training sessions
Treadmill walking performance - Walking Speed
Time frame: During the 20 weeks training sessions
Treadmill walking performance - Duration
Time frame: During the 20 weeks training sessions
Gait kinematics during FES-assisted gait training
Time frame: During the 10 week gait training with FES
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Thomas Janssen, Prof. Dr. principal investigator
Vrije Universiteit Amsterdam / Stichting Reade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES-assisted gait training in people with Incomplete Spinal Cord Injury (SCI) and SCI - Spinal Cord Injury, run by Stichting Reade at 1 site in Netherlands.
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 4 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
walking speed (time frame: From enrollment to the end of study at 33 weeks). 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 12 Jun 2026.