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Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bobath therapy and Matrix Rhythm Therapy
Bobath therapy
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke survivor, spasticity, Matrix Rhythm Therapy, balance, gait

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged between
  • to discharge from the hospital,
  • to have single-sided hemiparesis for the first time,
  • to have hemiparesis at least four weeks earlier.
  • to have Modified Rankin Score of ≤3, Modified Ashworth Scale score between 1-5 for the lower extremity.

Exclusion Criteria:

  • to use a cardiac pacemaker,
  • to have aphasia, open wound in the area to be treated,
  • to have circulatory problem, skin lesions, other neurological, psychiatric and/or orthopedic problems other than hemiparesis affecting gait.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bobath therapy plus Matrix Rhythm Therapy

    Bobath therapy

    Arm Description

    MRT application that was applied to the study group in addition to the Bobath therapy was applied to the affected side of the body and lower extremity for 60 minutes in each session.

    Both groups were treated with the Bobath therapy as a neurodevelopmental therapy.

    Outcomes

    Primary Outcome Measures

    Modified Ashworth Scale
    In 1987, Bohannon et al. developed the MAS(0,1,1+,2,3,4). In various studies, "0,1,2,3,4,5"scoring is used for MAS. "0" means no increase in muscle tone. "5" means affected part(s) rigid in flexion or extension. The validity and reliability of this scoring method in hemiparetic individuals have been shown with different studies.The spasticity values of quadriceps femoris muscle, hip adductor muscles, and gastrocnemius muscles in hemiparetic lower extremities of the participants were recorded. In addition, the total MAS score was determined in the affected lower extremity by summing up all values.
    The Single Leg Stance Test
    Evaluation of static balance: The Single Leg Stance Test (SLST) from Transitions/Anticipatory Postural Adjustments section, one of the BESTest Balance Evaluation System sub-parameters, was used.While SLST is performed, the patient's stance times on the right and left legs were recorded. During the test, a scoring between 0 and 3 was made according to whether or not the stability of two extremities could be maintained.The highest score a patient could receive was 6. Receiving a high score from four tests indicates that upright position was maintained.
    Timed "Get Up & Go" Test
    Evaluation of dynamic balance: The Timed "Get Up & Go" Test(TUG) from Stability in Gait section, one of the BESTest Balance Evaluation System sub-parameters, was used.The test started while the patient was sitting on a chair. Three meters from the chair was marked with colored tapes. The person was asked to stand up from chair,walk 3 meters forward,turn 180°,and walk back to the chair and sit on the chair.The completion time of the test was recorded in seconds. A scoring between 0-3 was made according to whether or not the balance is maintained during the test. Getting a high score from the test indicated good balance.
    Evaluation of Spatio-Temporal Parameters of Gait
    BTS G-Walk Spatio-temporal gait analysis system was used to evaluate gait parameters. Measurements were made in a pre-determined walking area of 10 m.In BTS G-Walk gait analysis system, the results are transferred via Bluetooth to the computer using an analysis port(sensor) connected to L4-L5 or L5-S1 levels of the patient.With the BTS G-Walk system,all important information such as spatio-temporal parameters of gait, general gait kinematics,pelvis, and spine kinematics can be reached.While this system compares the left and right extremities of the person with normal values during gait analysis,it also allows kinematic analysis of the pelvis to be performed in three planes.

    Secondary Outcome Measures

    Measurement of Joint Range of Motion
    Joint Range of Motion (ROM) was measured to determine active and passive joint motion limitation that spasticity can cause in muscle structure and secondarily in joint structure. Active and passive knee flexion-extension and ankle dorsiflexion-plantar flexion ROM were measured using a universal goniometer,whose clinical use is simple and rather practical.

    Full Information

    First Posted
    December 23, 2019
    Last Updated
    December 25, 2019
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04213417
    Brief Title
    Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors
    Official Title
    Effectiveness of Combining Matrix Rhythm Therapy and Bobath Toncept on Increased Muscle Tone, Balance and Gait Parameters in Stroke Individuals With Spastic Hemiparesis: A Single-Blind, Randomized, Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Matrix-Rhythm-Therapy(MRT) has been included in neuro-rehabilitation program for stroke patients to regulate increased muscle tone. There are no controlled studies with large sample size on the efficacy of MRT on spasticity. In this context,to the best of our knowledge, our study is the first study on this subject. The results of the study will develop a new perspective for management of spasticity and will ensure more common use of MRT.Further studies are needed on superiority of MRI over other treatment methods used in gait and balance rehabilitation of hemiparetic individuals. The aim of this study was to investigate the effectiveness of combining Bobath therapy (BT) and MRT on muscle tone,balance and gait parameters in stroke individuals with spastic hemiparesis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke survivor, spasticity, Matrix Rhythm Therapy, balance, gait

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bobath therapy plus Matrix Rhythm Therapy
    Arm Type
    Experimental
    Arm Description
    MRT application that was applied to the study group in addition to the Bobath therapy was applied to the affected side of the body and lower extremity for 60 minutes in each session.
    Arm Title
    Bobath therapy
    Arm Type
    Active Comparator
    Arm Description
    Both groups were treated with the Bobath therapy as a neurodevelopmental therapy.
    Intervention Type
    Other
    Intervention Name(s)
    Bobath therapy and Matrix Rhythm Therapy
    Intervention Description
    MRT application that was applied to the study group in addition to the BC was applied to the affected side of the body and lower extremity for 60 minutes in each session.The treatment was started from the thoracic region and a treatment direction was toward the lower extremity in the affected side.During the MRT procedure, the patient's active participation was ensured and the treatment was combined with the exercises.The patients were informed about MRT verbally and in writing before the application. Participants were treated 3 days a week for 4 weeks for a total of 12 sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Bobath therapy
    Intervention Description
    Both groups were treated with the BC as a neurodevelopmental therapy. Considering individual requirements and wishes of the patient, an exercise program that supports active participation of the person was established.Each treatment session was performed for 60 minutes.The treatment program that was established appropriately according to the patient contained weight transfer to the affected side in different positions,approximation to increase proprioceptive input, providing sensorial input to the sole of the foot using materials such as sensory ball,foot-ankle mobilization,functional reach activities, forward-side step, gait, and balance activities. Participants in both groups were treated 3 days a week for 4 weeks for a total of 12 sessions.
    Primary Outcome Measure Information:
    Title
    Modified Ashworth Scale
    Description
    In 1987, Bohannon et al. developed the MAS(0,1,1+,2,3,4). In various studies, "0,1,2,3,4,5"scoring is used for MAS. "0" means no increase in muscle tone. "5" means affected part(s) rigid in flexion or extension. The validity and reliability of this scoring method in hemiparetic individuals have been shown with different studies.The spasticity values of quadriceps femoris muscle, hip adductor muscles, and gastrocnemius muscles in hemiparetic lower extremities of the participants were recorded. In addition, the total MAS score was determined in the affected lower extremity by summing up all values.
    Time Frame
    1 year
    Title
    The Single Leg Stance Test
    Description
    Evaluation of static balance: The Single Leg Stance Test (SLST) from Transitions/Anticipatory Postural Adjustments section, one of the BESTest Balance Evaluation System sub-parameters, was used.While SLST is performed, the patient's stance times on the right and left legs were recorded. During the test, a scoring between 0 and 3 was made according to whether or not the stability of two extremities could be maintained.The highest score a patient could receive was 6. Receiving a high score from four tests indicates that upright position was maintained.
    Time Frame
    1 year
    Title
    Timed "Get Up & Go" Test
    Description
    Evaluation of dynamic balance: The Timed "Get Up & Go" Test(TUG) from Stability in Gait section, one of the BESTest Balance Evaluation System sub-parameters, was used.The test started while the patient was sitting on a chair. Three meters from the chair was marked with colored tapes. The person was asked to stand up from chair,walk 3 meters forward,turn 180°,and walk back to the chair and sit on the chair.The completion time of the test was recorded in seconds. A scoring between 0-3 was made according to whether or not the balance is maintained during the test. Getting a high score from the test indicated good balance.
    Time Frame
    1 year
    Title
    Evaluation of Spatio-Temporal Parameters of Gait
    Description
    BTS G-Walk Spatio-temporal gait analysis system was used to evaluate gait parameters. Measurements were made in a pre-determined walking area of 10 m.In BTS G-Walk gait analysis system, the results are transferred via Bluetooth to the computer using an analysis port(sensor) connected to L4-L5 or L5-S1 levels of the patient.With the BTS G-Walk system,all important information such as spatio-temporal parameters of gait, general gait kinematics,pelvis, and spine kinematics can be reached.While this system compares the left and right extremities of the person with normal values during gait analysis,it also allows kinematic analysis of the pelvis to be performed in three planes.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Measurement of Joint Range of Motion
    Description
    Joint Range of Motion (ROM) was measured to determine active and passive joint motion limitation that spasticity can cause in muscle structure and secondarily in joint structure. Active and passive knee flexion-extension and ankle dorsiflexion-plantar flexion ROM were measured using a universal goniometer,whose clinical use is simple and rather practical.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    20-65 years
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged between to discharge from the hospital, to have single-sided hemiparesis for the first time, to have hemiparesis at least four weeks earlier. to have Modified Rankin Score of ≤3, Modified Ashworth Scale score between 1-5 for the lower extremity. Exclusion Criteria: to use a cardiac pacemaker, to have aphasia, open wound in the area to be treated, to have circulatory problem, skin lesions, other neurological, psychiatric and/or orthopedic problems other than hemiparesis affecting gait.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    FİLİZ ALTUG, Prof.
    Organizational Affiliation
    Pamukkale University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    GÜLSÜM TIKAÇ, PT, MSc.
    Organizational Affiliation
    Pamukkale University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    UĞUR CAVLAK, Prof.
    Organizational Affiliation
    Avrasya University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32537732
    Citation
    Unal A, Altug F, Tikac G, Cavlak U. Effectiveness of matrix-rhythm therapy on increased muscle tone, balance and gait parameters in stroke survivors: a single-blinded, randomized, controlled clinical trial. Acta Neurol Belg. 2021 Jun;121(3):689-699. doi: 10.1007/s13760-020-01391-6. Epub 2020 Jun 14.
    Results Reference
    derived

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    Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors

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