To Investigate the Effects of Robotic-assisted Gait Training in Stroke Patients

February 4, 2020 updated by: FATOS KIRTEKE, Gazi University

Investigation Of The Effects Of Virtual Reality Application With Robotic Rehabilitation In Patients With Chronic Stroke.

The primary aim of the study was to investigate the effects of robot-assisted gait training and virtual reality on knee joint position sense in patients with chronic stroke. The secondary objective is to examine the effectiveness of these applications on functional gait and balance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite widespread prevention programs worldwide and advances in acute and subacute management and treatment protocols, stroke remains one of the most common causes of adult disability, representing a serious global health problem. Sensory motor dysfunction, proprioception deficits and hypertonus may develop in stroke patients depending on the location and severity of the brain damaged areas. Virtual reality application, which has been widely used in recent years, is a three-dimensional, computer-generated technology that gives the patient a sense of reality and allows the patient to interact with it. Virtual reality application can be used as a suitable method for proprioceptive rehabilitation due to its ability to manipulate visual feedback of virtual objects. In recent years, another technological method that has been used in the field of neurorehabilitation is robotic rehabilitation. Robot-assisted gait training, which requires repetitive tasks, can enhance neuroplasticity and motor learning, which focuses on the rearrangement of brain tissue. Both technology-based rehabilitation approaches have been shown to be particularly effective in improving the sense of position in the upper extremity. However, studies investigating the effects of these two applications on lower extremity position sensation seem to be insufficient. We think that both methods will be effective in improving the sense of position.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kozakli
      • Nevsehir, Kozakli, Turkey, 50600
        • Kozaklı Physical Therapy and Rehabilitation Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having been diagnosed with stroke by specialist physician,
  • 6 months after stroke diagnosis,
  • Hemiplegia or hemiparesis due to stroke for the first time,
  • Being over 18,
  • Being able to walk with auxiliary device or independently,
  • Mini Mental test score> 24,
  • Functional Ambulation Classification FAC ≥ 2,
  • Agree to participate in the study.

Exclusion Criteria:

  • Acute internal discomfort,
  • Botulinum toxin administration during 6 months before treatment or during treatment,
  • Presence of a history of previous stroke,
  • Having influence on both sides,
  • Neglect syndrome,
  • Presence of severe spasticity (Modified Ashwort Scale> 2),
  • Patients weighing more than 100 kg,
  • Patients with femoral lengths greater than 50cm

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: study group
virtual reality, robot-assisted gait training, conventional treatment
Other: virtual reality, robot assisted gait training
study group: 15 sessions virtual reality, robot assisted gait training
Other Names:
  • conventional treatment
Other: conventional treatment
study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment
Other: control group
conventional treatment
Other: conventional treatment
study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
functional ambulation classification (FAC)
Time Frame: Before treatment
FAC is used to assess ambulation ability. It is a valid and reliable scale that evaluates the physical support needed during gait from 6 to 0 points. A high score indicates a good gait and a decrease in score indicates a poor gait.
Before treatment
Activity-Specific Balance Safety Scale
Time Frame: change from baseline score at the end of 5 weeks
The level of confidence that the patient feels in daily life activities that require balance skills will be assessed with the Activity-Specific Balance Safety Scale. In this scale, individuals are asked to rate the safety feeling they feel between 0% and 100% when performing 16 activities that require the specified balance skill. A score of 100% indicates that the activity will be performed completely safely, and a score of 0% indicates that the activity is not safe at all.
change from baseline score at the end of 5 weeks
Modified Ashworth Scale
Time Frame: Before treatment
It is a reliable, valid scale commonly used in the assessment of muscle tone. Resistance to passive motion is graded between 0 and 4. A score of 0 defines normal in muscle tone. the score of 1 defines minimal resistance is felt at the end of the range of motion, the score of 1+ defines resistance is felt in less than half of the range of motion, the score of 2 defines resistance is felt in most of the range of motion, but the affected part is easily moved, the score of 3 defines the resistance along the range of motion of the joint is greater and passive movement is difficult, the score of 4 defines the joint movement of the points is restricted and movement is not revealed.
Before treatment
Modified Rankin Scale
Time Frame: change from baseline score at the end of 5 weeks
Modified Rankin Scale will be used to determine the disability level of stroke individuals. The Modified Rankin Scale is a widely used, reliable scale to assess functional status after stroke. In this scale, disability is defined at 7 levels. While 6 points are defined as death, 0 points define completely normal functional status. 0 points indicate no symptoms, 1 point indicates that there is no disability despite symptoms, 2 points indicate mild disability, 3 points moderate disability; 4 points moderate-severe disability; 5 points represent severe disability and 6 points represent death.
change from baseline score at the end of 5 weeks
Stroke Rehabilitation Movement Assessment Scale- STREAM
Time Frame: change from baseline score at the end of 5 weeks
STREAM, which is widely used in post-stroke motor evaluation, is a valid and reliable scale. STREAM consists of 2 sections and a total of 30 tests evaluating the functional movements and basic mobility activities of the upper and lower extremities. Limb movements are evaluated with 2 points and mobility activities with 3 points. The highest score is 70. A high score indicates that motor impairment is low, and a decrease in score indicates an increase in motor impairment.
change from baseline score at the end of 5 weeks
Time up and go test
Time Frame: change from baseline time at the end of 5 weeks
It is a test where balance and functional mobility are evaluated together.
change from baseline time at the end of 5 weeks
Mobile Phone-Based Joint Angle Measurement
Time Frame: change from baseline angle at the end of 5 weeks
DrGoniometer is an iPhone based joint goniometer application. With the DrGoniometer, the measurement is achieved by positioning a virtual goniometer that appears on the smartphone screen on a photo from the smartphone camera. The clinician takes a photograph of the extremity, records it, measures the joint angle and observes the value. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.
change from baseline angle at the end of 5 weeks
Berg Balance Scale
Time Frame: change from baseline score at the end of 5 weeks
It will be used to evaluate the functional balance. Berg balance scale includes 14 tests, which are graded between 0 and 4 by observing the patient's performance. higher values represent a better equilibrium state. A score of 0-20 indicates an imbalance, a score of 21-40 indicates an acceptable balance, a score of 41-56 indicates a good balance.
change from baseline score at the end of 5 weeks
goniometric measurement
Time Frame: change from baseline angle at the end of 5 weeks
Proprioception can be defined as the perception of the position and of the movement of various body parts in space. Its role is essential in sensorimotor control for movement acuity, joint stability, coordination, and balance. Its clinical evaluation is commonly based on the assessment of the joint position sense (JPS). Both ROM and JPS measurements require estimating angles through goniometer, scoliometer, laser-pointer, and bubble or digital inclinometer. The goniometer will be used to assess the sense of joint position. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.
change from baseline angle at the end of 5 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Arzu Güçlü Gündüz, prof., Gazi University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • gazi-ftr-neurological-rehab

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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