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

NCT05908175 | Completed

• 2 other identifiers: W23.009NL82880.015.22
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in average and maximum treadmill walking speed

  Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)

• Change in distance

  Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)

• Change in average overground walking speed

  Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

• Change in muscle activity

  Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

• Change in step length

  Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

Study Arms (1)

Intervention group

OTHER

FES-assisted gait training intervention group

Other: FES-assisted gait training

Interventions

FES-assisted gait training OTHER

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

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.

  Stichting Reade

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Pilot Study

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 18, 2023
• Study Start: May 10, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)