The Effect of Functional Electrical Stimulation Cycling Ergometry in Addition to Robotic Rehabilitation
NCT Number: NCT06541197
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries
Interventions: OTHER: Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group|OTHER: Robotic rehabilitation
Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2025-08-26

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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)., 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., 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., 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., at baseline and change from baseline TUGT at 4 weeks