NCT06912217

Comparison of the Effects of Robotic Rehabilitation, Functional Electrical Stimulation and Occupational Therapy on Upper Extremity and Hand Functions in Tetraplegic Patients With Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

2\. Purpose and Significance of the Study (Primary and Secondary Objectives, if any) Spinal cord injury (SCI) is a clinical condition characterized by partial or total loss of motor, sensory, and autonomic functions below the level of the lesion, depending on the severity and level of the injury, which may be caused by traumatic or non-traumatic factors. Globally, the incidence of SCI is estimated to be 250,000-500,000 cases per year . SCI patients may be classified as tetraplegic or paraplegic according to their functional levels. In paraplegia, there is a loss of function in both lower extremities, whereas tetraplegic patients experience functional loss in all four extremities. In both groups, autonomic dysfunctions in visceral organs can also be observed depending on the severity of the injury below the lesion level. In tetraplegic patients, loss of upper extremity and hand functions significantly reduces their level of independence in daily living activities, particularly in self-care tasks, and considerably lowers their quality of life. Therefore, upper extremity and hand rehabilitation play a crucial role in the comprehensive rehabilitation program for tetraplegic patients. Various rehabilitative modalities have been used both in clinical practice and in the literature to improve upper extremity and hand functions. The use of advanced rehabilitation technologies has increased in recent years. Studies on functional electrical stimulation (FES) for upper extremity, robotic rehabilitation, virtual reality applications, mirror therapy, and similar approaches have become more prevalent in the literature . However, there is a limited number of studies comparing the superiority of these rehabilitation techniques in tetraplegic patients, leading to insufficient data for selecting the most appropriate rehabilitative technologies in clinical practice. This study aims to compare the effects of FES, robotic rehabilitation, and occupational therapy on upper extremity and hand functions in tetraplegic patients. Additionally, it seeks to determine which patient groups, based on their clinical and demographic characteristics, would benefit the most from each therapy and to contribute to the development of personalized rehabilitation strategies by analyzing outcomes in the acute, subacute, and chronic phases of SCI.

Conditions

• Tetraplegia/Tetraparesis

Interventions

Type	Name	Description
DEVICE	robotic rehabilitation	It is planned to provide a robotic rehabilitation program for patients in the robotic group, in addition to conventional rehabilitation for 4 weeks, with 30 minutes, 3 days a week, focusing only on their dominant upper extremities.
DEVICE	Functional Electrical Stimulation	In the FES group, an upper extremity FES bicycle program (ADI) will be applied to the dominant upper extremity and hand, three days a week for 4 weeks.
OTHER	occupational therapy	In the occupational therapy group, patients will receive the planned treatment in addition to conventional rehabilitation for 4 weeks, three days a week, for 30 minutes.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-01
• Completion: 2025-09-30
• First posted: 2025-04-04
• Last updated: 2025-12-19

Locations

2 sites across 1 country: Turkey (Türkiye)