Clinical trial NCT05908175: FES-assisted Gait Intervention in People with Spinal Cord Injury - Pilot Study
Official title: FES-assisted Gait Training Intervention to Improve Gait in Individuals with an Incomplete Spinal Cord Injury - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Stichting Reade
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Assessed during week 11 during the post-intervention measurement.
measure: Incidence of (Serious) Adverse Events [Safety of the Intervention]
timeFrame: 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:
measure: Change in average and maximum treadmill walking speed
timeFrame: Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
measure: Change in distance
timeFrame: Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
measure: Change in average overground walking speed
timeFrame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
measure: Change in muscle activity
timeFrame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
measure: Change in step length
timeFrame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
measure: Change in step width
timeFrame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
measure: Change in cadence
timeFrame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Stichting Reade
Study officials:
affiliation: Stichting Reade
name: Thomas Janssen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: