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Completed

NCT Number: NCT05815823

Effect of Robotic Therapy on Upper Extremity With Stroke

The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.After conventional and robotic therapy Each patient was evaluated The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

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Key information

About this study

The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.

Materials and Methods: The study included 40 stroke patients. Two groups of patients were created. Group I also underwent 20 sessions of upper extremity robot-assisted therapy for 4 weeks, 5 days a week, for 30 minutes per session, in addition to receiving conventional therapy (5 days a week for 4 weeks, 1 hour each day). Group II only got traditional therapy. Each patient was assessed both before and after the procedure.

The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic or hemorhagic hemiplegia
  • Brunnstrom upper extremity motor stage ≥3
  • At least 3 months have passed
  • Modified Ashworth Score ≤2
  • 18-85 year old patients with diagnosis of stroke

Exclusion criteria

  • Aphasia
  • Cognitive impairment
  • mini mental test <24
  • deformity and / or contracture in the upper extremity
  • Patients diagnosed with KBAS

Treatment and study plan

robotic exercise therapy

Other

Functional exercise programs such as collecting rain in a glass, grating vegetables, goalkeeper, cleaning the stove, watering flowers, wiping windows, catching fish, and exploring landscapes were applied by robotic games to the patients

Other names: robotic exercise

Conventional Therapy

Other

streching, range of motion, strengthening, balance and walking exercise

Primary outcomes

  1. FMA-UE scale

    Time frame: baseline

    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.

  2. FMA-UE scale

    Time frame: after treatment (1 month)

    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Virtual Reality Assisted Upper Extremity Robotic Therapy on Pain, Daily Living Activities and Functional Status in Patients With Stroke

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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