Effect of Robotic Therapy on Upper Extremity With Stroke

April 4, 2023 updated by: Canan Avcı, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: conventional therapy
20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day
Other: conventional therapy
streching, range of motion, strengthening, balance and walking exercise
Experimental: robot-assisted therapy
20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.
Other: conventional therapy
streching, range of motion, strengthening, balance and walking exercise
Other: robotic exercise therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
after treatment (1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/14/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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