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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06306313
Other study ID # ReoGo
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2024
Est. completion date May 14, 2024

Study information

Verified date April 2024
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date May 14, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
Other:
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.

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl Meyer Upper Extremity Evaluation Scale It is a scale based on measuring performance and is frequently recommended for use especially in stroke patients. Test; It consists of subsections: reflex activity, flexor and extensor synergy, combined synergistic movements, non-synergistic movements, normal reflex activity, wrist and hand evaluation, coordination and speed evaluation. It consists of 33 items in total and each item is scored between 0 and 2 points (0: cannot do, 1: partially can, 2: completely can). Total score is 66. It is easy to apply, does not require a lot of equipment, items found at home are sufficient and takes about 30 minutes. Through study completion, an average of 3 months
Primary Functional Independence Scale It is used to evaluate the independence of patients in daily living activities. It has 13 items consisting of 4 subcategories to evaluate motor functional limitation, including self-care, sphincter control, transfer and displacement. To evaluate cognitive functional limitation, it has 5 items consisting of 2 subcategories including communication and social perception. It is a scale divided into 6 categories and consisting of 18 items in total. Each item is rated on a 7-point scale. A score of 7 indicates complete independence, while a score of 1 indicates maximum dependence. The lowest score that can be obtained from the scale is 18 and the highest score is 126. As the score obtained from the scale increases, the patient's level of independence increases. Through study completion, an average of 3 months
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