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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05908175
• Other study ID #: W23.009
• Secondary ID: NL82880.015.22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2023
• Source: Stichting Reade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Stichting Reade	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Stichting Reade

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)