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

Primary Purpose

Stroke, Cerebrovascular Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality, robot assisted gait training
conventional treatment
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring joint position sense, stroke, virtual reality, robot assisted gait training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kozaklı Physical Therapy and Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

study group

control group

Arm Description

virtual reality, robot-assisted gait training, conventional treatment

conventional treatment

Outcomes

Primary Outcome Measures

functional ambulation classification (FAC)
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.
Activity-Specific Balance Safety Scale
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.
Modified Ashworth Scale
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.
Modified Rankin Scale
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.
Stroke Rehabilitation Movement Assessment Scale- STREAM
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.
Time up and go test
It is a test where balance and functional mobility are evaluated together.
Mobile Phone-Based Joint Angle Measurement
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.
Berg Balance Scale
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.
goniometric measurement
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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
February 4, 2020
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04033185
Brief Title
To Investigate the Effects of Robotic-assisted Gait Training in Stroke Patients
Official Title
Investigation Of The Effects Of Virtual Reality Application With Robotic Rehabilitation In Patients With Chronic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Disorders
Keywords
joint position sense, stroke, virtual reality, robot assisted gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
virtual reality, robot-assisted gait training, conventional treatment
Arm Title
control group
Arm Type
Other
Arm Description
conventional treatment
Intervention Type
Other
Intervention Name(s)
virtual reality, robot assisted gait training
Other Intervention Name(s)
conventional treatment
Intervention Description
study group: 15 sessions virtual reality, robot assisted gait training
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment
Primary Outcome Measure Information:
Title
functional ambulation classification (FAC)
Description
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.
Time Frame
Before treatment
Title
Activity-Specific Balance Safety Scale
Description
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.
Time Frame
change from baseline score at the end of 5 weeks
Title
Modified Ashworth Scale
Description
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.
Time Frame
Before treatment
Title
Modified Rankin Scale
Description
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.
Time Frame
change from baseline score at the end of 5 weeks
Title
Stroke Rehabilitation Movement Assessment Scale- STREAM
Description
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.
Time Frame
change from baseline score at the end of 5 weeks
Title
Time up and go test
Description
It is a test where balance and functional mobility are evaluated together.
Time Frame
change from baseline time at the end of 5 weeks
Title
Mobile Phone-Based Joint Angle Measurement
Description
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.
Time Frame
change from baseline angle at the end of 5 weeks
Title
Berg Balance Scale
Description
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.
Time Frame
change from baseline score at the end of 5 weeks
Title
goniometric measurement
Description
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.
Time Frame
change from baseline angle at the end of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Güçlü Gündüz, prof.
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Kozaklı Physical Therapy and Rehabilitation Hospital
City
Nevsehir
State/Province
Kozakli
ZIP/Postal Code
50600
Country
Turkey

12. IPD Sharing Statement

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