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

Ankara City Hospital

Status: Completed

Conditions: Tetraplegia/Tetraparesis

Treatments: Other: occupational therapy; Device: Functional Electrical Stimulation; Device: robotic rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06912217

Hilal Arslan 001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Incomplete tetraplegia
• No cognitive impairment (Mini-Mental State Exam score ≥25)
• No significant visual deficits
• Ability to sit upright for at least 30 minutes
• No prior exposure to these treatments in the last six months

Exclusion criteria

• Severe upper extremity spasticity (MAS score 3-4)
• Severe shoulder pain or joint ROM restriction (>50%)
• Pre-existing neurological, rheumatological, or orthopedic conditions affecting upper extremity
• Severe cardiovascular disease
• Uncontrolled aggressive behavior
• Open wounds or infections at application sites
• Aphasia affecting comprehension
• Active deep vein thrombosis or thrombophlebitis in the upper extremity
• History of epilepsy or cyber disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

robotic rehabilitation

Active Comparator group

Description:

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. The program will be individualized for each patient through a treatment prescription consisting of games, tailored to their joint range of motion, muscle strength, functional status, skills, and perception. The goal is for patients to perform task-specific activities on a virtual screen using an exoskeleton (Armeo Power With Manova) robotic system. The robotic systems provide three-dimensional movement ability to the extremity with motor function loss.

Treatment:

Device: Functional Electrical Stimulation

Other: occupational therapy

Occupational therapy

Active Comparator group

Description:

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. Within the framework of this program, activities of daily living, especially self-care activities (eating, drinking, dressing, combing hair, brushing teeth, turning door handles, using remote controls, phones, and computers), as well as task-specific sensory and motor retraining and fine motor skills, will be worked on.

Treatment:

Device: robotic rehabilitation

Device: Functional Electrical Stimulation

Functional Electrical Stimulation

Active Comparator group

Description:

In the FES group, an FES bicycle program (RT300 FES leg cycle) will be applied for 4 weeks, three days a week for 30 minutes, focusing on the dominant upper extremity and hand. Electrodes will be placed on the target muscle groups. Electrodes will be placed on the elbow flexors and extensors, wrist flexors and extensors, and finger flexors and extensors. The current intensity will be adjusted according to the patient's tolerance.

Treatment:

Device: robotic rehabilitation

Other: occupational therapy