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

Primary Purpose

Spinal Cord Injuries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FES-assisted gait training
Sponsored by
Stichting Reade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Stichting Reade

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention group

Arm Description

FES-assisted gait training intervention group

Outcomes

Primary Outcome Measures

Feasibility of the intervention
Self-administered questionnaires about the training sessions, preceived effect, applicability of FES and the experience with walking with FES.
Incidence of (Serious) Adverse Events [Safety of the Intervention]
The total number of (serious) adverse events

Secondary Outcome Measures

Change in average and maximum treadmill walking speed
Average and maximum walking speed (m/s) recorded by the treadmill during each training session
Change in distance
Distance (in meters) recorded by the treadmill during each training session.
Change in average overground walking speed
Walking speed (m/s) measured by 10 meter walk test
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
Change in step length
Step length left and right (cm) measured during 10 meter walk test with the interactive walkway (kinect)
Change in step width
Step width (cm) measured during 10 meter walk test with interactive walkway (kinect)
Change in cadence
Cadence (steps/min) measured during 10 meter walk test with interactive walkway (kinect)

Full Information

First Posted
May 8, 2023
Last Updated
June 8, 2023
Sponsor
Stichting Reade
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1. Study Identification

Unique Protocol Identification Number
NCT05908175
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stichting Reade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Other
Arm Description
FES-assisted gait training intervention group
Intervention Type
Other
Intervention Name(s)
FES-assisted gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the intervention
Description
Self-administered questionnaires about the training sessions, preceived effect, applicability of FES and the experience with walking with FES.
Time Frame
Assessed during week 11 during the post-intervention measurement.
Title
Incidence of (Serious) Adverse Events [Safety of the Intervention]
Description
The total number of (serious) adverse events
Time Frame
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 Measure Information:
Title
Change in average and maximum treadmill walking speed
Description
Average and maximum walking speed (m/s) recorded by the treadmill during each training session
Time Frame
Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
Title
Change in distance
Description
Distance (in meters) recorded by the treadmill during each training session.
Time Frame
Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
Title
Change in average overground walking speed
Description
Walking speed (m/s) measured by 10 meter walk test
Time Frame
Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Title
Change in muscle activity
Description
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
Time Frame
Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Title
Change in step length
Description
Step length left and right (cm) measured during 10 meter walk test with the interactive walkway (kinect)
Time Frame
Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Title
Change in step width
Description
Step width (cm) measured during 10 meter walk test with interactive walkway (kinect)
Time Frame
Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Title
Change in cadence
Description
Cadence (steps/min) measured during 10 meter walk test with interactive walkway (kinect)
Time Frame
Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Janssen, Prof. Dr.
Organizational Affiliation
Stichting Reade
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stichting Reade
City
Amsterdam
ZIP/Postal Code
1054HW
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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