Upper Extremity Robot-Assisted Therapy in Stroke Patients

Hacettepe University

Status: Not yet enrolling

Conditions: Stroke; Upper Extremity

Treatments: Device: Assist-On Arm Robot Group; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06382454

E2-23-5921

Details and patient eligibility

About

Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spasticity of the upper extremity muscles is 2 or less according to the Modified Ashworth Scale
• Stroke patients with a Mini Mental State Examination score of 24 and above will be included in the study

Exclusion criteria

• Have a neurological disease other than stroke that may affect upper extremity movements
• Surgery or botox application for upper extremity spasticity in the last 6 months
• History of upper extremity fracture or surgery
• Attending another rehabilitation program
• Individuals who do not agree to participate in the study and do not give written informed consent will be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Treatment Group

Experimental group

Description:

30 minutes of individualized trunk, lower extremity and upper extremity exercises; the other 30 minutes will be treated with the robotic system. In the robot-assisted treatment, a total of 12 movements will be used, including the movement patterns that patients have the most difficulty in daily life and two movement patterns used in the Proprioceptive Neuromuscular Facilitation approach. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day.

Treatment:

Device: Assist-On Arm Robot Group

Control Group

Active Comparator group

Description:

For 30 minutes, exercises including trunk, lower extremity and upper extremity exercises specific to the individual will be practiced, while the movement patterns to be used in the robotic system will be practiced in the other 30 minutes with the physiotherapist. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day.

Treatment:

Other: Control Group