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

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT04033185
Collaborator
(none)
40
1
2
3.2
12.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: virtual reality, robot assisted gait training
  • Other: conventional treatment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation Of The Effects Of Virtual Reality Application With Robotic Rehabilitation In Patients With Chronic Stroke.
Actual Study Start Date :
Oct 15, 2019
Actual Primary Completion Date :
Dec 5, 2019
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. functional ambulation classification (FAC) [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.

    2. Activity-Specific Balance Safety Scale [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.

    3. Modified Ashworth Scale [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.

    4. Modified Rankin Scale [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.

    5. Stroke Rehabilitation Movement Assessment Scale- STREAM [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.

    6. Time up and go test [change from baseline time at the end of 5 weeks]

      It is a test where balance and functional mobility are evaluated together.

    7. Mobile Phone-Based Joint Angle Measurement [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.

    8. Berg Balance Scale [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.

    9. goniometric measurement [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kozaklı Physical Therapy and Rehabilitation Hospital Nevsehir Kozakli Turkey 50600

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Study Director: Arzu Güçlü Gündüz, prof., Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    FATOS KIRTEKE, principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT04033185
    Other Study ID Numbers:
    • gazi-ftr-neurological-rehab
    First Posted:
    Jul 25, 2019
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by FATOS KIRTEKE, principal Investigator, Gazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 5, 2020