The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury

NCT ID: NCT05726773

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2023-05-15

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.

Conditions

Tetraplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robot Assisted Therapy Group

In the RAT group, it was planned to perform robotic rehabilitation with a hand-finger robot \[Amadeo (Tyromotion, Graz, Austria)\] for 30 minutes for both upper extremities, accompanied by a physiotherapist who is trained in robotic rehabilitation and has at least 5 years of experience. In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.

Group Type: EXPERIMENTAL

Robot Assisted Therapy

Intervention Type: PROCEDURE

In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.

Conventional Therapy

Intervention Type: PROCEDURE

In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.

Conventional Therapy Group

In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: PROCEDURE

In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.

Interventions

Robot Assisted Therapy

In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.

Intervention Type: PROCEDURE

Conventional Therapy

In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Sevda Adar

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVDA ADAR

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Sevda Adar

Afyonkarahisar, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SATETRA

Identifier Type: -

Identifier Source: org_study_id