Status:

COMPLETED

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

Lead Sponsor:

Ankara University

Conditions:

Stroke

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief 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 ...

Detailed Description

This study is planned as a prospective randomized single blind controlled study. It was approved by the Ethics Committee of Ankara University, Faculty of Medicine and will be conducted in accordance w...

Eligibility Criteria

Inclusion

  • Patients within the age range of 18-80 years
  • Patients with subacute stroke (post-stroke duration 1 month - 1 year)
  • Patients who have cognitive deficits and who can understand the commands to adapt to robotic training (MMSE ≤ 26)
  • Patients with first stroke attack
  • Patients who have never received robotic rehabilitation therapy
  • Patients with upper extremity (UE) Brunnstrom Stage III and above
  • Patients with a spasticity level below 3 (MAS 1-5 assessment system) according to the modified Ashworth Scale (MAS) in the affected upper extremity
  • Patients who agreed to participate in the study and signed the informed consent form

Exclusion

  • Patients who cannot understand commands or give informed consent
  • Patients without cognitive deficit (MMSE \> 26)
  • Patients with aphasia
  • Patients who do not have sitting balance
  • Patients with unilateral neglect
  • Patients with unstable systemic medical diseases that may prevent the patient to receive robotic training sessions
  • Patients with psychiatric disorders
  • Patients with posterior cerebral artery infarction and subarachnoid hemorrhage
  • Patients with impaired vision that may affect robotic training
  • Patients with a peripheral nerve injury or musculoskeletal disease of the affected upper extremity
  • Patients who have pain in the affected upper extremity such that this pain might impede the patient to adapt to robotic training
  • Patients with involuntary abnormal movements (e.g. dystonia)

Key Trial Info

Start Date :

September 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 29 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04335422

Start Date

September 1 2019

End Date

July 29 2022

Last Update

January 31 2024

Active Locations (1)

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Ankara University

Ankara, Turkey (Türkiye), 06230