Clinical trial NCT06541197: The Effect of Functional Electrical Stimulation Cycling Ergometry in Addition to Robotic Rehabilitation
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
functional electrical stimulation bicycle ergometry
robotic rehabilitation
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: at baseline and change from baseline WISCI II at 4 weeks
Secondary outcomes:
measure: Lower Extremity Motor Score (LEMS)
timeFrame: at baseline and change from baseline LEMS at 4 weeks
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: at baseline and change from baseline SCIM at 4 weeks
measure: Ten (10)-Meter Walk Test
timeFrame: at baseline and change from baseline 10-meter walk test at 4 weeks
measure: Two (2)-Minute Walk Test
timeFrame: at baseline and change from baseline 2-minute walking test at 4 weeks
measure: Timed Up and Go Test (TUGT)
timeFrame: at baseline and change from baseline TUGT at 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: Associate professor
name: Merve Örücü Atar, MD
role: PRINCIPAL_INVESTIGATOR
References: