Effects of Robot-Assisted Upper Extremity Training on Cognitive and Physical Functions After Stroke

NCT04335422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-31

No results posted yet for this study

Summary

Stroke is a main cause of disability worldwide. It is characterized by motor and cognitive impairments leading to activity limitations and participation restrictions. Despite improvement in mortality and morbidity following stroke, stroke survivors need access to effective rehabilitation services. Management approach for stroke survivors is classical physical and rehabilitation medicine (PRM) interventions. Nowadays, with the advancement of technology, robotic rehabilitation systems have taken its place among the classical physical and rehabilitation medicine applications. Robotic systems for upper and lower extremity help to improve neuroplasticity by repetitive task-specific activities. Upper extremity robotic systems can be either exoskeleton or end-effector according to their mechanical designs. Exoskeleton robotic systems attach to both proximal and distal segments of the upper extremity (shoulder, elbow, forearm, wrist, fingers) and provide antigravity weight support allowing actuated axes of movements of the upper extremity joints. The system allows the reinforcement and facilitation of movements by means of visual feedback with a 3-dimensional virtual environment in which the patient is asked to perform various tasks by playing computer games. It is reported that robotic therapy can be used complementary to other rehabilitation methods. The neurophysiological effects of robotic therapy were shown to act in the brain, particularly on the primary motor cortex, putamen and capsula interna. The effect on motor recovery was associated with common, synchronous activity involving the corticospinal system. It has been reported by a recent Cochrane review that robot-assisted arm training improves arm function, arm muscle strength and activities of daily living in stroke survivors. A few studies have also reported positive effects on cognitive abilities. However, there are no controlled studies in the literature investigating the effects of robot-assisted upper limb training on cognitive functions following stroke. The aim of this study was to investigate the effects of robot-assisted upper extremity training, applied in addition to the classical PRM program, on cognitive and physical functions after stroke. Primary aim is to investigate the effects on cognitive functions whereas secondary aim is to investigate the effects on upper extremity motor functions and activities of daily living. The investigators hypothesized that adjunctive robotic upper extremity training in addition to classical PRM program would result in better cognitive and physical outcomes compared with the classical PRM program only.

Conditions

Interventions

DEVICE

Robotic group (Upper extremity robot-assisted training plus routine physical and rehabilitation medicine program)

Upper extremity robot-assisted training will include facilitated shoulder flexion-extension, internal-external rotation, abduction-adduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, ulnar-radial deviation, hand finger flexion-extension movements by means of visual feedback with a 3-dimensional virtual environment in which the patient is asked to perform various tasks such as object reaching, grasping, holding, dropping activities by playing computer games. Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.

BEHAVIORAL

Control group (routine physical and rehabilitation medicine program)

Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-06-30
Completion
2022-07-29

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335422 on ClinicalTrials.gov