FES-assisted Gait Training for Incomplete Spinal Cord Injury

NCT07645144 | Enrolling By Invitation

• 2 other identifiers: W25.058NL-010640
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incomplete Spinal Cord Injury (SCI); SCI - Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of study at 33 weeks

Secondary Outcomes (13)

• Spatiotemporal gait parameters - step length

  From enrollment to the end of study at 33 weeks

• Spatiotemporal gait parameters - step width

  From enrollment to the end of study at 33 weeks

• Spatiotemporal gait parameters - Cadence

  From enrollment to the end of study at 33 weeks

• Functional ambulation - WISCI II

  From enrollment to the end of study at 33 weeks

• Functional ambulation - Hoffer classification

  From enrollment to the end of study at 33 weeks

Study Arms (1)

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.

Other: FES-assisted gait training

Interventions

FES-assisted gait training OTHER

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.

Conventional gait training

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stichting Reade: lead

Study Sites (1)

Stichting Reade

Amsterdam, 1054HW, Netherlands

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Thomas Janssen, Prof. Dr.

  Vrije Universiteit Amsterdam / Stichting Reade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 12, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)