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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group; Other: Robotic rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06541197

AESH-EK1-2024-0088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

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

Robotic rehabilitation

Active Comparator group

Description:

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.

Treatment:

Other: Robotic rehabilitation