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Completed

NCT Number: NCT06541197

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group

Other

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 Rehabilitation

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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