Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke

NCT ID: NCT06306313

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2024-10-14

Brief Summary

The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.

It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.

In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period.

Conditions

Stroke; Upper Extremity Paresis

Study Design

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

Study Groups

Experimental

Conventional physiotherapy will be applied in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition, robot-assisted therapy will be applied with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. Evaluations will be made at the beginning and end of the treatment process.

Group Type: EXPERIMENTAL

ReoGo

Intervention Type: DEVICE

ReoGo is a fixed arm rehabilitation exoskeleton that comes on a small and compact wheeled platform. The end-effector extension is capable of producing a wide range or repeatable movements in 3D space. ReoGo can be used by both adults and children. It is an arm rehabilitation exoskeleton with a fixed base. Its design allows limited controlled movements of the shoulder as well as the elbow and wrist.

Conventional Physiotherapy

Intervention Type: OTHER

Physiotherapy protocols will be created with traditional physiotherapy practices such as neurodevelopmental techniques based on muscle strengthening and task-oriented exercises. Protocols in general terms; It will include passive and active joint range of motion exercises, stretching exercises, stimulation and facilitation techniques, strengthening exercises, fine motor skills and functional task training for daily living activities. Protocols will be tailored to each patient's level of motor impairment and functional needs.

Control Group

The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. Evaluations will be made at the beginning and end of the treatment process.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: OTHER

Physiotherapy protocols will be created with traditional physiotherapy practices such as neurodevelopmental techniques based on muscle strengthening and task-oriented exercises. Protocols in general terms; It will include passive and active joint range of motion exercises, stretching exercises, stimulation and facilitation techniques, strengthening exercises, fine motor skills and functional task training for daily living activities. Protocols will be tailored to each patient's level of motor impairment and functional needs.

Interventions

ReoGo

ReoGo is a fixed arm rehabilitation exoskeleton that comes on a small and compact wheeled platform. The end-effector extension is capable of producing a wide range or repeatable movements in 3D space. ReoGo can be used by both adults and children. It is an arm rehabilitation exoskeleton with a fixed base. Its design allows limited controlled movements of the shoulder as well as the elbow and wrist.

Intervention Type: DEVICE

Conventional Physiotherapy

Physiotherapy protocols will be created with traditional physiotherapy practices such as neurodevelopmental techniques based on muscle strengthening and task-oriented exercises. Protocols in general terms; It will include passive and active joint range of motion exercises, stretching exercises, stimulation and facilitation techniques, strengthening exercises, fine motor skills and functional task training for daily living activities. Protocols will be tailored to each patient's level of motor impairment and functional needs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having had a single stroke
• Having had at least 6 months since the stroke
• Having hemiparesis/hemiplegia following the stroke
• Having mental health sufficient to meet all evaluation and treatment procedures in the study

Exclusion Criteria

• Having a history of disease other than stroke that affects the use of the upper extremity

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Fatih Tekin

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ReoGo

Identifier Type: -

Identifier Source: org_study_id