Spinal Cord InjuriesNCT05908175

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

A study testing FES-assisted gait training in people with Spinal Cord Injuries, run by Stichting Reade at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injuries
What is being tested?: FES-assisted gait training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteNetherlands
Study dates: 10 May 2023to 7 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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;

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Stichting Reade
Amsterdam, 1054HW

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions: Spinal Cord Injuries
Being tested: FES-assisted gait training
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FES-assisted gait trainingOther
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.

Study groups in NCT05908175
Study group	Role	What they receive
Intervention group	Other	FES-assisted gait training intervention group Receives: Other: FES-assisted gait training

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of the intervention
Self-administered questionnaires about the training sessions, preceived effect, applicability of FES and the experience with walking with FES.
Measured: 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
Measured: 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
Average and maximum walking speed (m/s) recorded by the treadmill during each training session
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 20237 Jun 2024

First posted18 Jun 2023
Study start10 May 2023
Primary completion7 Jun 2024
Study completion7 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Pilot Study
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05908175
Sponsor's protocol ID: W23.009
Other IDs: NL82880.015.22
Status last verified: Dec 2024
First submitted: 8 May 2023
Last updated: 18 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FES-assisted Gait Training Intervention to Improve Gait in Individuals with an Incomplete Spinal Cord Injury - a Pilot Study
ClinicalTrials.gov ID: NCT05908175
Acronym / sponsor ID: W23.009
Conditions: Spinal Cord Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Stichting ReadeUniversity, hospital or other
Study start: 10 May 2023 (actual)
Primary completion: 7 Jun 2024 (actual)
Study completion: 7 Jun 2024 (actual)
First posted: 18 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Pilot Study

Arm	Type	Receives
Intervention group	Other	Other: FES-assisted gait trainingFES-assisted gait training intervention group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FES-assisted gait trainingThe participants will walk with functional electrical stimulation (and possible body weight support) on a treadmill for 10 weeks, twice a week for 30 minutes.	Other	Intervention group

Primary outcome

Feasibility of the intervention
Time frame: Assessed during week 11 during the post-intervention measurement.
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]
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)
The total number of (serious) adverse events

7 secondary outcomes

Change in average and maximum treadmill walking speed
Time frame: Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
Change in distance
Time frame: Assessed during each FES-assisted gait training session (from week 1 until week 10, 2x a week)
Change in average overground walking speed
Time frame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in muscle activity
Time frame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in step length
Time frame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in step width
Time frame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)
Change in cadence
Time frame: Assessed before and after the 10-weeks FES-assisted gait training intervention (during week 0 and week 11)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injuries

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Janssen, Prof. Dr. principal investigator

Stichting Reade

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FES-assisted gait training in people with Spinal Cord Injuries, run by Stichting Reade at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the intervention (time frame: Assessed during week 11 during the post-intervention measurement.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.