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

NCT06541197 | Completed

• 1 other identifier: AESH-EK1-2024-0088
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; functional electrical stimulation bicycle ergometry; robotic rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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).

  at baseline and change from baseline WISCI II at 4 weeks

Secondary Outcomes (5)

• Lower Extremity Motor Score (LEMS)

  at baseline and change from baseline LEMS at 4 weeks

• Spinal Cord Independence Measure (SCIM)

  at baseline and change from baseline SCIM at 4 weeks

• Ten (10)-Meter Walk Test

  at baseline and change from baseline 10-meter walk test at 4 weeks

• Two (2)-Minute Walk Test

  at baseline and change from baseline 2-minute walking test at 4 weeks

• Timed Up and Go Test (TUGT)

  at baseline and change from baseline TUGT at 4 weeks

Study Arms (2)

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.

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.

Other: Robotic rehabilitation

Interventions

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 combined with Functional Electrical Stimulation (FES) bicycle ergometry group

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.

Robotic rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

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

Study Officials

• Merve Örücü Atar, MD

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: November 1, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: December 5, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)