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

December 4, 2025 updated by: Merve Örücü Atar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe spasticity or joint contracture in the lower extremities that impedes movement.
  2. Presence of metallic implants in the lower extremities.
  3. Stage 2 or higher pressure ulcers on the sacral or coccygeal regions.
  4. Co-existing peripheral neuropathy.
  5. Permanent urinary catheter use.
  6. 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).
  7. Psychiatric disorders or cognitive problems that prevent completing questionnaires and assessment scales.
  8. Presence of other neurological or muscular diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group
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.
Other: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group
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.
Active Comparator: Robotic rehabilitation
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.
Other: Robotic rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at baseline and change from baseline WISCI II at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower Extremity Motor Score (LEMS)
Time Frame: at baseline and change from baseline LEMS at 4 weeks
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.
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
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).
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
A measure of ambulation where the patient walks a 10-meter distance at a normal pace, and the time taken is recorded.
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
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.
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
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.
at baseline and change from baseline TUGT at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Merve Örücü Atar, MD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

September 5, 2025

Study Completion (Actual)

September 5, 2025

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AESH-EK1-2024-0088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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