FES-assisted Gait Training for Incomplete Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FES-assisted gait training.
- Who it may be relevant to
- Registry conditions: Incomplete Spinal Cord Injury (SCI), SCI - Spinal Cord Injury. Basic parameters: 17 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Automated Multi-channel Closed-loop Functional Electrical Stimulation Assisted Gait to Improve Gait in People With Incomplete Spinal Cord Injury
Overview
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.
Interventions
- Other 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 elec
Primary outcome measures
- walking speed [Time frame: From enrollment to the end of study at 33 weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- Stichting Reade — Amsterdam
Identifiers
NCT: NCT07645144 · W25.058 · NL-010640