Spinal Cord InjuriesNCT06541197

The Effect of Functional Electrical Stimulation Cycling Ergometry in Addition to Robotic Rehabilitation

A study testing Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group and Robotic rehabilitation in people with Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

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 to 65 years
Conditions the study is for: Spinal Cord Injuries
What is being tested?: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group and Robotic rehabilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Nov 2024to 5 Sep 2025
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Motor Incomplete spinal cord injury (ASIA C and D).
At least 6 months post spinal cord injury.
Age between 18 and 65 years.
Ability to walk at least 10 meters independently or with assistive devices such as a cane or crutches.
Signed informed consent form indicating willingness to participate in the study.

Who cannot join

Severe spasticity or joint contracture in the lower extremities that impedes movement.
Presence of metallic implants in the lower extremities.
Stage 2 or higher pressure ulcers on the sacral or coccygeal regions.
Co-existing peripheral neuropathy.
Permanent urinary catheter use.
Contraindications for walking exercises (e.g., cognitive impairment preventing exercise compliance, unstable epilepsy or unexplained convulsions, unstable acute cardiac arrhythmia or heart failure, presence of a cardiac pacemaker).
Psychiatric disorders or cognitive problems that prevent completing questionnaires and assessment scales.
Presence of other neurological or muscular diseases.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Adding Functional Electrical Stimulation Bicycle Ergometry to Robotic Rehabilitation on Walking Function and Lower Extremity Functional Recovery in Patients With Chronic Incomplete Spinal Cord Injury

Authors' aim in this study is to investigate the effect of adding functional electrical stimulation (FES) bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI.

Read the detailed description

Spinal cord injury (SCI) is a devastating neurological condition resulting from either traumatic or non-traumatic causes, leading to loss of motor, sensory, and autonomic functions in individuals. Statistics indicate that more than 75% of individuals with incomplete SCI regain some degree of ambulatory function. To the authors' knowledge, no other study has investigated the effect of adding FES bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI. Authors' hypothesis is that the group receiving FES bicycle ergometry in addition to robotic rehabilitation will achieve better functional recovery and ambulation compared to the group receiving only robotic rehabilitation. In this context, authors' aim in this study is to investigate the effect of adding functional electrical stimulation bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI.

Conditions: Spinal Cord Injuries
Being tested: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group, Robotic rehabilitation
Keywords: spinal cord injury, functional electrical stimulation bicycle ergometry, robotic rehabilitation
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.

Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry groupOther
Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions before robotic rehabilitation.
Robotic rehabilitationOther
Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks.

Study groups in NCT06541197
Study group	Role	What they receive
Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group	Active comparator	Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions under the supervision of a physician before robotic rehabilitation. Receives: Other: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group
Robotic rehabilitation	Active comparator	Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. Receives: Other: Robotic rehabilitation

What is being measured

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

Walking Index for Spinal Cord Injury (WISCI II)
An index that evaluates walking ability post-SCI, scoring from 0 to 20 based on the need for personal assistance, use of orthoses, walkers, crutches, canes, or no assistive devices. Scores for the WISCI II scale range from 0 to 20 (0: most severe impairment, 20: mild impairment).
Measured: at baseline and change from baseline WISCI II at 4 weeks

Secondary outcomes (5)

Lower Extremity Motor Score (LEMS)
A method for determining muscle strength in key motor muscles of the lower extremities according to the ASIA impairment scale. (0) No observable or palpable muscle contraction. (1) Observable or palpable muscle contraction, but no joint movement. (2) Completes joint movement when gravity is eliminated. (3) Completes joint movement against gravity, but no resistance. (4) Completes joint movement against moderate resistance. (5) Completes joint movement against full resistance. Total score for the LEMS scale range from 0 to 50.
Measured: at baseline and change from baseline LEMS at 4 weeks
Spinal Cord Independence Measure (SCIM)
An assessment tool for physical disabilities and independence in daily living activities for SCI patients. It consists of three main sections: self-care, respiration and sphincter control, and mobility, with a total score ranging from 0 to 100 (higher scores indicate greater independence).
Measured: at baseline and change from baseline SCIM at 4 weeks
Ten (10)-Meter Walk Test
A measure of ambulation where the patient walks a 10-meter distance at a normal pace, and the time taken is recorded.
Measured: at baseline and change from baseline 10-meter walk test at 4 weeks
Two (2)-Minute Walk Test
Measure of functional capacity where the patient walks the maximum distance possible in 2 minutes on a marked 30-meter flat and firm surface. The 2-minute walk test is a safe alternative to the 6-minute walk test, particularly in SCI patients, as it shows a strong correlation with it.
Measured: at baseline and change from baseline 2-minute walking test at 4 weeks
Timed Up and Go Test (TUGT)
An evaluation of mobility where patients are asked to rise from a chair, walk a 3-meter distance, return, and sit down, with the time taken recorded. Assistive devices may be used if needed.
Measured: at baseline and change from baseline TUGT at 4 weeks

Timeline

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

1 Nov 20245 Sep 2025

First posted7 Aug 2024
Study start1 Nov 2024
Primary completion5 Sep 2025
Study completion5 Sep 2025

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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06541197
Sponsor's protocol ID: AESH-EK1-2024-0088
Status last verified: Nov 2024
First submitted: 2 Aug 2024
Last updated: 5 Dec 2025
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

Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Reticulospinal Control of Movements
Spinal Cord Injuries, Healthy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)

All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Adding Functional Electrical Stimulation Bicycle Ergometry to Robotic Rehabilitation on Walking Function and Lower Extremity Functional Recovery in Patients With Chronic Incomplete Spinal Cord Injury
ClinicalTrials.gov ID: NCT06541197
Acronym / sponsor ID: AESH-EK1-2024-0088
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury, functional electrical stimulation bicycle ergometry, robotic rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
Study start: 1 Nov 2024 (actual)
Primary completion: 5 Sep 2025 (actual)
Study completion: 5 Sep 2025 (actual)
First posted: 7 Aug 2024 (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: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group	Active comparator	Other: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry groupRobotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions under the supervision of a physician before robotic rehabilitation.
Robotic rehabilitation	Active comparator	Other: Robotic rehabilitationRobotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Motor Incomplete spinal cord injury (ASIA C and D).
At least 6 months post spinal cord injury.
Age between 18 and 65 years.
Ability to walk at least 10 meters independently or with assistive devices such as a cane or crutches.
Signed informed consent form indicating willingness to participate in the study.

Key exclusion criteria (8 listed)

Severe spasticity or joint contracture in the lower extremities that impedes movement.
Presence of metallic implants in the lower extremities.
Stage 2 or higher pressure ulcers on the sacral or coccygeal regions.
Co-existing peripheral neuropathy.
Permanent urinary catheter use.

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
Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry groupRobotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions before robotic rehabilitation.	Other	Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group
Robotic rehabilitationRobotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks.	Other	Robotic rehabilitation

Primary outcome

Walking Index for Spinal Cord Injury (WISCI II)
Time frame: at baseline and change from baseline WISCI II at 4 weeks
An index that evaluates walking ability post-SCI, scoring from 0 to 20 based on the need for personal assistance, use of orthoses, walkers, crutches, canes, or no assistive devices. Scores for the WISCI II scale range from 0 to 20 (0: most severe impairment, 20: mild impairment).

5 secondary outcomes

Lower Extremity Motor Score (LEMS)
Time frame: at baseline and change from baseline LEMS at 4 weeks
Spinal Cord Independence Measure (SCIM)
Time frame: at baseline and change from baseline SCIM at 4 weeks
Ten (10)-Meter Walk Test
Time frame: at baseline and change from baseline 10-meter walk test at 4 weeks
Two (2)-Minute Walk Test
Time frame: at baseline and change from baseline 2-minute walking test at 4 weeks
Timed Up and Go Test (TUGT)
Time frame: at baseline and change from baseline TUGT at 4 weeks

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 5 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injuries

Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Reticulospinal Control of Movements
Spinal Cord Injuries, Healthy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)

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.

Merve Örücü Atar, MD principal investigator

Associate professor

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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 5 Dec 2025. 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 Turkey (Türkiye). 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?

Walking Index for Spinal Cord Injury (WISCI II) (time frame: at baseline and change from baseline WISCI II at 4 weeks). 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 NCT06541197.

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 5 Dec 2025.