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FES-assisted Gait Training for Incomplete Spinal Cord Injury (FES-SCI)

8. Juni 2026 aktualisiert von: Stichting Reade

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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Niederlande
      • Amsterdam, Niederlande, 1054HW
        • Stichting Reade

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Conventional gait training
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.
Sonstiges: FES-assisted gait training
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
walking speed
Zeitfenster: 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
From enrollment to the end of study at 33 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Spatiotemporal gait parameters - step length
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Spatiotemporal gait parameters - step width
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Spatiotemporal gait parameters - Cadence
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Functional ambulation - WISCI II
Zeitfenster: From enrollment to the end of study at 33 weeks
Evaluated at T0, T1, T2, and T3 using the WISCI II (0-20).
From enrollment to the end of study at 33 weeks
Functional ambulation - Hoffer classification
Zeitfenster: From enrollment to the end of study at 33 weeks
Evaluated at T0, T1, T2, and T3 using the Hoffer classification (5-point scale).
From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - Center of Activity
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - full width at half maximum
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Muscle activity and neuromuscular coordination - Co-contraction
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Muscle strength
Zeitfenster: From enrollment to the end of study at 33 weeks
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.
From enrollment to the end of study at 33 weeks
Treadmill walking performance - Distance Covered
Zeitfenster: During the 20 weeks training sessions
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.
During the 20 weeks training sessions
Treadmill walking performance - Walking Speed
Zeitfenster: During the 20 weeks training sessions
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.
During the 20 weeks training sessions
Treadmill walking performance - Duration
Zeitfenster: During the 20 weeks training sessions
Treadmill walking performance is monitored across all 40 training sessions. Duration (min) is recorded by the treadmill software at the end of each session.
During the 20 weeks training sessions
Gait kinematics during FES-assisted gait training
Zeitfenster: During the 10 week gait training with FES
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.
During the 10 week gait training with FES

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stichting Reade

Ermittler

  • Hauptermittler: Thomas Janssen, Prof. Dr., Vrije Universiteit Amsterdam / Stichting Reade

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Februar 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • W25.058
  • NL-010640 (Registrierungskennung: CCMO)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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