FES-assisted Gait Intervention in People with Spinal Cord Injury - Pilot Study

FES-assisted Gait Training Intervention to Improve Gait in Individuals with an Incomplete Spinal Cord Injury - a Pilot Study

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities such as walking. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Locomotor training with FES may be a promising method to improve gait function. The primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. Secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: FES-assisted gait training

Detailed Description

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities, such as walking. These limitations are associated with muscle weakness, a disturbance of the reflex activity, and the inability or difficulty to recruit muscles below the lesion. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Studies that investigated the effect of locomotor training on a treadmill with functional electrical stimulation and/or body weight support (BWS) show improved function of the lower limbs. FES-assisted gait therapy may be a promising method for improving gait function in individuals with an incomplete SCI. Therefore, this study will investigate if an FES-assisted gait (with BWS) is feasible and safe. This study will also investigfate if an FES-assisted gait can improve gait function in people with an incomplete SCI.

Primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. The secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1054HW
    • Stichting Reade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a non-progressive incomplete SCI.
• Have limited motor abilities in the lower extremities.
• Be able to walk on a treadmill for 30 minutes (with body weight support).
• Be able to perform the 10 meter walk test overground with assistive devices and/or support form the researcher/physician.
• Have a stable medical condition.
• Have had the SCI for at least a year.
• Be at least 18 years of age.

Exclusion Criteria:

• Cardiac arrhythmias or cardiac disease;
• Flaccid paralysis.
• Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training;
• A history of severe autonomic dysreflexia assessed with the 'Autonomic standards assessment';
• Neurostimulator, pacemaker, or other device that prevents the safe use of electrical stimulation present in the body;
• Very high sensitivity to electrical stimulation, i.e., sensitivity threshold is reached before motor responses are observed in all target muscles;
• Insufficient mastery of the Dutch language (speaking and reading);
• Severe cognitive or communicative disorders;
• Being or becoming pregnant during the study period;
• Severe psychiatric illness or disorders (at the discretion of the treating rehabilitation physician);
• Involved in another intervention study which may have an effect on the outcome measures of the present study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group; FES-assisted gait training intervention group	Other: FES-assisted gait training; The participants will walk with functional electrical stimulation (and possible body weight support) on a treadmill for 10 weeks, twice a week for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention	Self-administered questionnaires about the training sessions, preceived effect, applicability of FES and the experience with walking with FES.	Assessed during week 11 during the post-intervention measurement.
Incidence of (Serious) Adverse Events [Safety of the Intervention]	The total number of (serious) adverse events	Assessed during week 1 to 10 for each FES-assisted gait training session (2x week) and in week 0, week 11 and week 21 (during the pre-, post- and follow-up measurements)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average and maximum treadmill walking speed	Average and maximum walking speed (m/s) recorded by the treadmill during each training session	Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
Change in distance	Distance (in meters) recorded by the treadmill during each training session.	Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
Change in average overground walking speed	Walking speed (m/s) measured by 10 meter walk test	Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in muscle activity	Surface EMG measurement during 10 meter walk test. Time of muscle activation and duration of muscle activity of the m. rectus femoris, m. vastus lateralis, m. semitendinosus, m. tibialis anterior, m. gastrocnemius medialis, m. soleus and m. peroneus longus	Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in step length	Step length left and right (cm) measured during 10 meter walk test with the interactive walkway (kinect)	Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in step width	Step width (cm) measured during 10 meter walk test with interactive walkway (kinect)	Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in cadence	Cadence (steps/min) measured during 10 meter walk test with interactive walkway (kinect)	Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

Collaborators and Investigators

• Sponsor: Stichting Reade
• Investigators: Principal Investigator: Thomas Janssen, Prof. Dr., Stichting Reade

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): June 7, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: W23.009; NL82880.015.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No