Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tetraplegia/Tetraparesis
Keywords: Spinal Cord Injury
Tetraplegia
Hand Functions
Occupational Therapy
Functional Electrical Stimulation
Robotic Rehabilitation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a parallel-group, open-label, prospective, randomized clinical trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: Nine-Hole Peg Test
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: Hand Grip Strength Assessment (Using a Dynamometer)
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: Pinch Grip Strength (Pinchmeter)
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: American Spinal Injury Association (ASIA):
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: ASIA Impairment Scale
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: Joint Range of Motion Assessment
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
measure: Spinal Cord Injury Independence Measure (SCI Independence Measure) - Self-Care Subparameter
timeFrame: Evaluation at Treatment Start and 4 Weeks Later
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
References: