Upper Extremity Robot-Assisted Therapy in Stroke Patients

NCT ID: NCT06382454

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2025-03-30

Brief Summary

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.

Conditions

Stroke; Upper Extremity

Study Design

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

Study Groups

Treatment Group

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.

Group Type: EXPERIMENTAL

Assist-On Arm Robot Group

Intervention Type: DEVICE

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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

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.

Interventions

Assist-On Arm Robot Group

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.

Intervention Type: DEVICE

Control Group

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.

Intervention Type: OTHER

Other Intervention Names

Assist-On Arm Robot

Eligibility Criteria

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.

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

Sponsors

Interact Medical Technologies Inc.

UNKNOWN

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Izel Demirhan

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammed Kılınç, Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İzel Demirhan, Msc

Role: CONTACT

izel.dmrhn16@gmail.com

+905379858812

Ender Ayvat, Assoc. Prof.

Role: CONTACT

Other Identifiers

E2-23-5921

Identifier Type: -

Identifier Source: org_study_id