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Effects of End-effector Type Robot Assisted Gait Therapy on Gait Pattern and Energy Consumption in Chronic Post-stroke Hemiplegic Patients

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ClinicalTrials.gov Identifier: NCT03709329
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Restoration of gait independence in stroke patients is one of the most important goals of rehabilitation therapy, and gait rehabilitation is one of the most important treatments in the treatment of stroke because it is a major factor affecting rehabilitation after stroke. In the rehabilitation of patients with post - stroke walking disorders, previous physical therapy was mainly manual therapy using therapist 's physical effort and walking training with walking aids. In recent years, however, emphasis has been placed on therapies based on motor learning concepts, which allow the patient to intensively train the exercise as closely as possible to the ultimate goal.

The robot used for walking rehabilitation includes exoskeleton walking robot such as Lokomat® (Hocoma AG, Switzerland), Walkbot-G® (P & S Mechanics, Korea), MorningWalk® (Curexo, Korea) According to the Systematic Review, which compares two types of robot-assisted gait treatment divided into end-effector type, which is not an exoskeletal type such as System® (Rehatech, Switzerland) It has been reported that the percentage of patients who were able to walk independently when treated with a robot was higher than that of an exoskeleton-type robot.

In this regard, in terms of acquisition of independent gait, studies on the therapeutic effect of the exoskeleton-type robot and the end-effector-type robot before and after the gait therapy were continuously performed, but 80% of the patients obtained independent gait, Despite the fact that many of these patients have abnormal walking, research has not yet been conducted. In previous studies, there was a statistically significant improvement in parameters of Gait speed, Cadence, and step length when compared with spatiotemporal parameters in training using exoskeleton robots for stroke patients. In another study, Gait speed and Cadence did not show a statistically significant improvement, and the effect on Gait speed and Cadence is still unknown. However, unlike exoskeletal robots, end-effector robotic gait training has been reported to improve Gait speed in most studies compared to conventional gait training. In addition, Cadence, Temporal symmetry ratio, Single, an improved side stride length, an improvement in the symmetry index of stance phase, and an improvement in Gait endurance.

In this way, the end effector type robot walking training is more likely to improve walking quality than the exoskeleton type robot. The end-effector type robot, which is different from the exoskeleton type, reproduces the gait using the ankle joint to induce the movement of the knee joint and the hip joint. Therefore, it is possible to control the ankle joint, which is essential for improving the gait pattern. It is considered that the end effector type robot which can control the ankle joint is more likely to induce the improvement of the gait pattern than the existing exoskeleton type robot because it shows limitations in reproducing the ankle rocker motion.


Condition or disease Intervention/treatment Phase
Chronic Post-stroke Hemiplegic Patients Device: Robot Assisted Gait Therapy Device: Conventional Gait Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Single blinded Randomized controlled study design is divided into two groups: robot-assisted walking group and conventional walking group. The random assignment is performed by Stratified Permuted Block Randomization to match Sex and Age between the two groups, and the subject is assigned using a randomly generated table before the start of the study so that the evaluator can not know what kind of treatment the subject is receiving.

Both groups undergo unassisted overground walking condition before and after treatment and after 6 weeks of treatment.

Plain gait condition at the time of evaluation: When walking, several 8-meter-long plazas are walked several times to induce a natural walk, and three natural gait cycles are selected.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator and Outcome assessors were blinded to types of treatment the patients received until the end of the study.
Primary Purpose: Treatment
Official Title: Effects of End-effector Type Robot Assisted Gait Therapy on Gait Pattern and Energy Consumption in Chronic Post-stroke Hemiplegic Patients
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019

Arm Intervention/treatment
Experimental: Robot Assisted Gait Therapy
The robot-assisted gait treatment will receive 18 treatments per patient for 1 week, 3 times a week, and 6 weeks for 30 minutes a day.
Device: Robot Assisted Gait Therapy
The robot-assisted gait treatment will receive 18 treatments per patient for 1 week, 3 times a week, and 6 weeks for 30 minutes a day.

Active Comparator: Conventional Gait Therapy
The conventional gait therapy group receives a total of 18 classical gait training sessions once a day for 30 minutes and three times a week for 6 weeks. Classical gait training consisted of exercise training based on neurophysiological theories such as Bobath, restraint of rigid and cooperative movements by therapists, exercise training in sitting or standing posture, Gait training and balance training, weight training of the paralyzed lower limb.
Device: Conventional Gait Therapy
The conventional gait therapy group receives a total of 18 classical gait training sessions once a day for 30 minutes and three times a week for 6 weeks. Classical gait training consisted of exercise training based on neurophysiological theories such as Bobath, restraint of rigid and cooperative movements by therapists, exercise training in sitting or standing posture, Gait training and balance training, weight training of the paralyzed lower limb.




Primary Outcome Measures :
  1. Difference of Self selected gait velocity between before and after Robot Assisted Gait Therapy [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    The change of gait speed that the patient feels most comfortable with according to the flow of the three time points (before and immediately after treatment and after 6 weeks of treatment)


Secondary Outcome Measures :
  1. Difference between two interventional groups according to the time course [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    Three-dimensional motion analysis

  2. Dynamic EMG [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    The EMG signal will be measured by attaching the surface EMG to the skin over the Medial GCM, Tibialis Anterior, Vastus Medialis, Rectus Femoris, Medial Hamstring, and Gluteus Maximus muscles. The EMG signal will be measured and converted to root mean square (RMS) values.

  3. Foot pressure [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    The foot pressure will be measured using a F-Scan® system (Tekscan, USA) with a 0.16-mm thick, 980 force-sensing resistors (3.88 sensors per centimeter square) After inserting the pressure insoles, calibrating will be done according to the Tekscan user manual. Then the parameters below will be measured.

  4. Fugl-Meyer Assessment(FMA) for Lower extremities [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]

    The following five measures, calculated as 34 points

    E. LOWER EXTREMITY:

    i. Reflex activity ii. Volitional movement within synergies iii. Volitional movement mixing synergies iv. Volitional movement with little or no synergy v. Normal reflex activity F. COORDINATION / SPEED: out of six i. Tremor ii. Dysmetria iii. Time


  5. 10m walking test [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    Measure the time using a stopwatch when walking at a distance of 10 meters from the starting point, 2 meters, 8 meters, 10 meters.

  6. Berg balance scale(BBS) [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]

    Balance assessment tool consisting of 14 items and 56 points Scoring: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score(Summed each item's subscores) = 0-56 Interpretation: 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk, A change of 8 points is required to reveal a genuine change in function between 2 assessments.

    Item(Subscores ranging from 0-4 for each): Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers, Standing with eyes closed, Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot


  7. Timed up and go test(TUG) [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    • Static and dynamic balance Measuring tool measures the time to get up from the chair, move forward 3 meters, and then return to sit on the chair
    • <10 seconds is normal
    • 11-20 seconds: normal limits for frail elderly and disabled patients
    • 20 seconds or more: Needs assistance in outdoor gait
    • 30 seconds or more: risk of falling too high

  8. Functional Ambulation Category(FAC) [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]

    Rated as 0 ~ 5 points for evaluating the independence of walking 0 point: If you can not walk or need more than 2 people

    1. point: One person needs sustained support to balance or move the body center
    2. points: If you need one intermittent help to help balance or negotiate
    3. points: Independent walking is possible under instruction or observation without physical contact.
    4. points: You can walk on the ground independently, but you need help when you walk on stairs, ramps, or unstable flat
    5. points: If you are able to walk completely independently regardless of the terrain

  9. Modified Ashworth Scale(MAS) [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]

    0: No increase in muscle tone

    1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension

  10. Rivermead Mobility Index(RMI) [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]
    Indicators for assessing mobility disability in terms of gait, balance, and transfer in stroke patients. Out of 15 items, 14 self-report items and 1 observation item. Evaluate each item as Yes (1 point) / No (0 points). The more difficult the items from 1 to 15, the higher the degree of difficulty, the higher the score, the higher the mobility performance

  11. Functional independence measure(FIM) [ Time Frame: before and immediately after treatment and after 6 weeks of treatment ]

    Indicators for assessing independence in performing daily living activities A total of 18 items, with a maximum of 7 points per item, a minimum of 126 points Items 7:Complete Independence (Timely, Safely) 6: Modified Independence (Device) 5: Supervision (Subject = 100%+) 4: Minimal Assist (Subject = 75%+) 3: Moderate Assist (Subject = 50%+) 2: Maximal Assist (Subject = 25%+)

    1: Total Assist (Subject = less than 25%)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stroke patient visited Shinchon Severance Hospital Rehabilitation Department
  • Adults over 19 years
  • Ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging or computed tomography
  • Patients who have had a stroke for more than 3 months
  • Those who have hemiplegia after a stroke
  • If the walking pattern is abnormal and the walking speed is less than 0.8m / sec
  • Those who have a score of K-MMSE score of 24 or higher in the Korean version
  • A person who can walk independently with 3 or more points in the Functional Ambulation Category (FAC) classified as 0 ~ 5 according to the degree of need for assistance in walking
  • The patients who understand the research and have voluntary participation

Exclusion Criteria:

  • Those who have difficulty walking before stroke
  • Modified Ashworth scale of the lower extremity muscle is 3 or more
  • Patients with ataxia
  • Severe lower extremity joints, osteoporosis, and untreated fractures.
  • Patients who weigh more than 135kg
  • Damage of the skin in contact with the machine during robot walking
  • Patients who underwent orthopedic or neurosurgical surgery within 6 months of the start of the study
  • uncontrolled hypertension or orthostatic hypotension
  • Patients who are likely to spread pathogenic microorganisms due to contact
  • Not cutting
  • Cardiovascular disease, venous thrombosis or heart failure, respiratory disease
  • Malignant neoplasm
  • Other basic diseases that can not tolerate robot assisted walking
  • If the tester is judged as not suitable for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709329


Locations
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Korea, Republic of
Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Deog-Young Kim, MD, Ph.D    82-2-2228-3714    kimdy@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03709329     History of Changes
Other Study ID Numbers: 1-2018-0032
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
End-effector
Robot Assisted Gait Therapy
Gait Pattern
Energy Consumption
Chronic stroke
Hemiplegia
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases