StrokeNCT04213417
Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors
A study testing Bobath therapy and Matrix Rhythm Therapy and Bobath therapy in people with Stroke, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bobath therapy and Matrix Rhythm Therapy and Bobath therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Bobath therapy and Matrix Rhythm Therapy, Bobath therapy
- Keywords
- stroke survivor, spasticity, Matrix Rhythm Therapy, balance, gait
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath therapy and Matrix Rhythm TherapyOther
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.
Bobath therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bobath therapy plus Matrix Rhythm Therapy | Experimental | 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. Receives: Other: Bobath therapy and Matrix Rhythm Therapy |
| Bobath therapy | Active comparator | Both groups were treated with the Bobath therapy as a neurodevelopmental therapy. Receives: Other: Bobath therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE ÜNAL, Pamukkale University
- Investigators
- FİLİZ ALTUG, Prof., Study chair, Pamukkale UniversityGÜLSÜM TIKAÇ, PT, MSc., Principal investigator, Pamukkale UniversityUĞUR CAVLAK, Prof., Study director, Avrasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213417
- Sponsor's protocol ID
- 27.12.2016/81261
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32537732
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04213417
- Acronym / sponsor ID
- 27.12.2016/81261
- Conditions
- Stroke
- Keywords
- stroke survivor, spasticity, Matrix Rhythm Therapy, balance, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath therapy plus Matrix Rhythm Therapy | Experimental | Other: Bobath therapy and Matrix Rhythm TherapyMRT 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. |
| Bobath therapy | Active comparator | Other: Bobath therapyBoth groups were treated with the Bobath therapy as a neurodevelopmental therapy. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bobath therapy and Matrix Rhythm TherapyMRT 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. | Other | Bobath therapy plus Matrix Rhythm Therapy |
| Bobath therapyBoth 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. | Other | Bobath therapy |
Primary outcome
Modified Ashworth Scale
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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.
1 secondary outcome
Measurement of Joint Range of Motion
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Derived from this study: PubMed 32537732Unal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FİLİZ ALTUG, Prof. study chair
Pamukkale University
GÜLSÜM TIKAÇ, PT, MSc. principal investigator
Pamukkale University
UĞUR CAVLAK, Prof. study director
Avrasya University
Questions about this trial
What is this clinical trial studying?
A study testing Bobath therapy and Matrix Rhythm Therapy and Bobath therapy in people with Stroke, run by Pamukkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04213417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.