Clinical trial NCT05726773: The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury
Official title: The Effect of Robot Assisted Hand Therapy on Hand Functions and Quality of Life in Patients With Spinal Cord Injury: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetraplegia
Keywords: Tetraplegia
Spinal cord injury
Robotic assisted therapy
Hand rehabilitation
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 30
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: Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. In this study, our aim is to compare the effects of robot-assisted hand therapy and conventional physiotherapy on hand functions and quality of life in patients with spinal cord injury.

Detailed description: Spinal cord injury (SCI) is considered one of the most devastating injuries that cause lifelong disability.Among the impaired functions, upper extremity function is one of the most important goals of rehabilitation for these individuals.Hand functions are among the most important determinants of independence.Some studies have reported that in more than half of people with tetraplegia, restoring arm and hand function will improve quality of life.Therefore, small improvements in upper extremity function can make a clinically significant difference in feeding, bathing, transferring and other functional activities.Given that the majority of individuals with spinal cord injuries are in their most productive years and life expectancy approaches that of the healthy population, more aggressive treatment strategies that focus on improving peripheral muscle control and recovery of the central nervous system (CNS) are needed.Recently, treatment based on the 'motor learning theory' has been reported to be effective in the recovery of impaired upper extremity function.It has been shown that by repetitive movements as intense as possible to help achieve the ultimate goal of optimum movement, patients are able to learn motor skills that lead to CNS recovery.It has also been suggested that repetitive and activity-based exercise may facilitate recovery after spinal cord injury by inducing practice-dependent brain and spinal cord plasticity.Therefore, repetitive, intensive, and activity-based upper extremity rehabilitative therapy can help improve impaired upper extremity function.In this context, robotic therapy (RT) may be an alternative way of delivering rehabilitative therapy to patients with tetraplegia, as RT can deliver consistently high-intensity, high-repetition, and task-specific training with less effort compared to conventional therapy.

Eligibility criteria: Inclusion criteria:

* Mini mental test score \>15
* Able to understand the commands
* Had a function between 1 and 4 in at least one of the key muscle strengths in at least one hand.

Exclusion Criteria:

* Patients with persistent pain in the upper extremity (VAS\>40)
* Patients with severe spasticity in the hand (MAS≥3)
* Patients with severe limitation of joint range of motion / contracture in the hand
* Patients who had fractures or operations in the upper extremity in the last 6 months
* Patients who received botulinum toxin injection to the upper extremity in the last 6 months
* Patients with skin ulcers
* Patients with severe visual impairment and severe depression
* Patients who cannot sit in a chair for more than 30 minutes
* Patients with a history of stroke or progressive neurodegenerative disease
* Patients with neuromuscular disease
* Patients with uncontrolled epilepsy

Primary outcomes:
measure: American spinal cord injury association impairment scale
timeFrame: 15 minutes
measure: Sollerman hand function test
timeFrame: 60 minutes
measure: Nine Hole Peg Test
timeFrame: 20 minutes
measure: Box and block test
timeFrame: 30 minutes
measure: Jamar pinchmeter
timeFrame: 5 minutes
measure: Jamar hand dynamometer
timeFrame: 5 minutes
Secondary outcomes:
measure: Spinal cord injury independence scale
timeFrame: 15 minutes
measure: Modified Ashworth Scale
timeFrame: 10 minutes
measure: Functional Independence Scale
timeFrame: 15 minutes
measure: Short form 36
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Sevda Adar
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: SEVDA ADAR
role: PRINCIPAL_INVESTIGATOR
References: