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
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke survivor, spasticity, Matrix Rhythm Therapy, balance, gait
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.
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
NCT ID
NCT04213417
First Posted
December 23, 2019
Last Updated
December 25, 2019
Sponsor
Pamukkale University
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
Learn more about this trial
Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors
We'll reach out to this number within 24 hrs