FES-assisted Gait Training for Incomplete Spinal Cord Injury (FES-SCI)
8 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Amsterdam, Holanda, 1054HW
- Stichting Reade
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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walking speed
Prazo: From enrollment to the end of study at 33 weeks
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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
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From enrollment to the end of study at 33 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Spatiotemporal gait parameters - step length
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Spatiotemporal gait parameters - step width
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Spatiotemporal gait parameters - Cadence
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Functional ambulation - WISCI II
Prazo: From enrollment to the end of study at 33 weeks
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Evaluated at T0, T1, T2, and T3 using the WISCI II (0-20).
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From enrollment to the end of study at 33 weeks
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Functional ambulation - Hoffer classification
Prazo: From enrollment to the end of study at 33 weeks
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Evaluated at T0, T1, T2, and T3 using the Hoffer classification (5-point scale).
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From enrollment to the end of study at 33 weeks
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Muscle activity and neuromuscular coordination - Center of Activity
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Muscle activity and neuromuscular coordination - full width at half maximum
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Muscle activity and neuromuscular coordination - Co-contraction
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Muscle strength
Prazo: From enrollment to the end of study at 33 weeks
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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.
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From enrollment to the end of study at 33 weeks
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Treadmill walking performance - Distance Covered
Prazo: During the 20 weeks training sessions
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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.
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During the 20 weeks training sessions
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Treadmill walking performance - Walking Speed
Prazo: During the 20 weeks training sessions
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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.
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During the 20 weeks training sessions
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Treadmill walking performance - Duration
Prazo: During the 20 weeks training sessions
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Treadmill walking performance is monitored across all 40 training sessions.
Duration (min) is recorded by the treadmill software at the end of each session.
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During the 20 weeks training sessions
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Gait kinematics during FES-assisted gait training
Prazo: During the 10 week gait training with FES
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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.
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During the 10 week gait training with FES
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Thomas Janssen, Prof. Dr., Vrije Universiteit Amsterdam / Stichting Reade
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de fevereiro de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de junho de 2026
Primeira postagem (Real)
12 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- W25.058
- NL-010640 (Identificador de registro: CCMO)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .