StrokeNCT05256030
The Effect of Speed-based Training on Spasticity and Balance
A study testing Speed-based relearning training and Neurodevelopmental Therapy in people with Stroke and Spasticity, Muscle, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
While there are many studies examining the effect of different exercises on spasticity and balance activities in individuals with stroke, no study has been found on the effect of speed-based re-learning training on spasticity and balance activities. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke, Spasticity, Muscle, Balance; Distorted
- What is being tested?
- Speed-based relearning training and Neurodevelopmental Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Sep 2022
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-stroke hemiparetic-hemiplegic clinical picture
- Getting 0-3 points according to the Modified Rankin Scale
- Brunnstorm lower extremity stage≥ 2
- Getting a score of 24 or higher on the Mini Mental test
- Being clinically stable
- Having a stroke for the first time
- Single hemisphere involvement
Who cannot join
- Not having spasticity
- Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Speed-based Re-learning Training on Spasticity Characteristics and Balance Activities in Stroke Patients.
While there are many studies examining the effect of different exercises on spasticity and balance activities in individuals with stroke, no study has been found on the effect of speed-based re-learning training on spasticity and balance activities. In this study, it was aimed to investigate whether the WBV treatment protocol determined has an effect on functional capacity and respiratory functions in individuals with stroke. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.
Read the detailed description
Stroke is one of the diseases with the highest mortality and disability rates worldwide. Spasticity is a motor disorder that affects more than 12 million people worldwide after stroke and is one of the most important causes of disability. Physiologically, spasticity affects the motor pathways of the brainstem and alters the excitability of motor neurons in the spinal cord, resulting in a reduction in the supraspinal-inhibitory-control mechanisms necessary for the regulation of the stretch reflex.
Spasticity is generally defined as "a motor disorder characterized by a speed-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex as a component of the upper motor neuron syndrome". The muscle that develops spasticity creates a resistance to the movement during different movements and activities and makes it difficult to perform the movement. The resistance felt is due not only to neural causes, but also to peripheral causes (biomechanical factors such as soft tissue or muscle properties). Spasticity shows different characters at different speeds. The velocity-dependent increase in muscle tone is an important feature of spasticity. The stretching speed has obvious effects on the catching angle. However, the velocity dependence of spasticity may be partially dependent on joint angle position.
Spasticity, which occurs due to a structural and physiological anomaly, creates a disordered contractile behavior characteristic in the structures of the muscles it affects. Therefore, spasticity should be considered not only as a rehabilitated phenomenon, but also as a disrupted behavior pattern that should be suppressed. In spastic cases, lesion of the motor cortex and corticospinal tract is accompanied by loss of supraspinal inhibition. During activities such as standing and walking, spasticity leads to the activation of a synergistic pattern. Depending on the increase in the extensor tone of the upper extremities, flexor lower extremities, balance and gait problems occur in various degrees in patients. Spasticity reduces functional capacity, increases metabolic energy expenditure and causes disruptions in daily work. Considering the number of people affected by spasticity and functional disability caused by the neural and motor sequelae of the disease, it is of great importance to seek new forms of evaluation and treatment for the rehabilitation of affected patients.
Improving walking safety and speed and preventing falls are the main goals of gait rehabilitation for stroke survivors. For these reasons, the patient should be approached from a holistic point of view rather than the classical point of view in stroke rehabilitation. Hemiplegic gait is not the result of isolated skeletal muscle dysfunction seen after orthopedic disorders. Therefore, spasticity and spastic activation time should be considered in the treatment. Walking is not only a displacement activity; It should be considered as a concept that includes the simultaneous coordination of all the muscles that need to be active, providing the highest efficiency and quality with the least energy expenditure.
The spastic threshold rate is defined as the minimum rate at which spastic response is observed during controlled open chain measurements. It is estimated that the spastic threshold rate decreases as the severity of stroke increases in stroke patients. However, the relationship between the onset of stretch-induced muscle activation and the resistance (catching) felt by clinicians in stroke survivors has not been fully investigated. Also, it is not clear whether the catch angle also depends on the joint angle position. Spasticity is clinically related to speed, joint position, angle of capture, etc. should be revealed quickly, rehabilitation practices should be made specific to the person and the activity. By raising the spastic rate threshold, the emergence of spasticity in the early phase should be prevented, even at higher velocities. In the management of spasticity, with a current point of view, classical rehabilitation practices should be avoided and motor learning strategies specific to the patient should be introduced. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.
- Conditions
- Stroke, Spasticity, Muscle, Balance; Distorted
- Being tested
- Speed-based relearning training, Neurodevelopmental Therapy
- Keywords
- Stroke, Velocity, Re-learning, Spasticity, Balance
- 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.
Speed-based relearning trainingOther
Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed.
Neurodevelopmental TherapyOther
Neurodevelopmental Therapy
| Study group | Role | What they receive |
|---|---|---|
| Control-Traditional Rehabilitation Group | Experimental | This group will receive a 6-week neurorehabilitation program that includes stretching for spasticity inhibition, strengthening of the antagonist muscle, autogenic inhibition methods, as well as conscious-unconscious balance training and gait training, which are routinely applied in physical therapy and rehabilitation units. The treatment will be applied 5 days a week.
In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions Receives: Other: Speed-based relearning training |
| Study-Neurodevelopmental Therapy Group | Experimental | Function-oriented Neurodevelopmental Therapy will be applied to the subjects included in the study and randomly assigned to the study group in different positions such as supine, prone, sitting, standing for 6 weeks, 5 sessions per week, and the goal will be to achieve the task at different speeds. Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed. Receives: Other: Neurodevelopmental Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Tardieu Scale
The scale evaluates spasticity from three different rates in order to evaluate the rate-dependent effect of spasticity. These speeds are defined as speeds V1, V2 and V3. The speed V1 represents the evaluation at the lowest speed, and V3 represents the evaluation at the highest speed. In all 3 speeds, the target joints are moved passively through the full range of motion and the range of values in which spasticity is observed is calculated by means of a goniometer.
Measured: 6 weeks
Berg Balance Scale
It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently.
Measured: 6 weeks
Time Up and Go Test
The person is asked to get up from the chair he is sitting in, walk 3 meters at a safe and normal pace, turn, walk back and sit back in the chair. The time it takes to complete the test is recorded in seconds.
Measured: 6 weeks
Portable computerized kinesthetic balance device (SportKAT 550)
The device consists of two parts, an electronic tilt sensor and a moving platform. The electronic sensor evaluates the movement of the platform during the test period and transfers the data to the connected computer. The computer screen is placed 1 meter in front of the people and at eye level to provide feedback to the people. The computer screen has a red cross indicating the movement of the platform. The evaluated person tries to keep this sign on the screen in the center for 30 seconds. At the end of the test, the device calculates a balance score. This score shows how close the person holds the platform to the reference position. At the end of the test, scores ranging from 0 to 6000 are formed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Duray, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256030
- Sponsor's protocol ID
- E-60116787-020-168618
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Speed-based Re-learning Training on Spasticity Characteristics and Balance Activities in Stroke Patients.
- ClinicalTrials.gov ID
- NCT05256030
- Acronym / sponsor ID
- E-60116787-020-168618
- Conditions
- Stroke, Spasticity, Muscle, Balance; Distorted
- Keywords
- Stroke, Velocity, Re-learning, Spasticity, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 25 Feb 2022 (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.
While there are many studies examining the effect of different exercises on spasticity and balance activities in individuals with stroke, no study has been found on the effect of speed-based re-learning training on spasticity and balance activities. In this study, it was aimed to investigate whether the WBV treatment protocol determined has an effect on functional capacity and respiratory functions in individuals with stroke. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.
Detailed description
Stroke is one of the diseases with the highest mortality and disability rates worldwide. Spasticity is a motor disorder that affects more than 12 million people worldwide after stroke and is one of the most important causes of disability. Physiologically, spasticity affects the motor pathways of the brainstem and alters the excitability of motor neurons in the spinal cord, resulting in a reduction in the supraspinal-inhibitory-control mechanisms necessary for the regulation of the stretch reflex.
Spasticity is generally defined as "a motor disorder characterized by a speed-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex as a component of the upper motor neuron syndrome". The muscle that develops spasticity creates a resistance to the movement during different movements and activities and makes it difficult to perform the movement. The resistance felt is due not only to neural causes, but also to peripheral causes (biomechanical factors such as soft tissue or muscle properties). Spasticity shows different characters at different speeds. The velocity-dependent increase in muscle tone is an important feature of spasticity. The stretching speed has obvious effects on the catching angle. However, the velocity dependence of spasticity may be partially dependent on joint angle position.
Spasticity, which occurs due to a structural and physiological anomaly, creates a disordered contractile behavior characteristic in the structures of the muscles it affects. Therefore, spasticity should be considered not only as a rehabilitated phenomenon, but also as a disrupted behavior pattern that should be suppressed. In spastic cases, lesion of the motor cortex and corticospinal tract is accompanied by loss of supraspinal inhibition. During activities such as standing and walking, spasticity leads to the activation of a synergistic pattern. Depending on the increase in the extensor tone of the upper extremities, flexor lower extremities, balance and gait problems occur in various degrees in patients. Spasticity reduces functional capacity, increases metabolic energy expenditure and causes disruptions in daily work. Considering the number of people affected by spasticity and functional disability caused by the neural and motor sequelae of the disease, it is of great importance to seek new forms of evaluation and treatment for the rehabilitation of affected patients.
Improving walking safety and speed and preventing falls are the main goals of gait rehabilitation for stroke survivors. For these reasons, the patient should be approached from a holistic point of view rather than the classical point of view in stroke rehabilitation. Hemiplegic gait is not the result of isolated skeletal muscle dysfunction seen after orthopedic disorders. Therefore, spasticity and spastic activation time should be considered in the treatment. Walking is not only a displacement activity; It should be considered as a concept that includes the simultaneous coordination of all the muscles that need to be active, providing the highest efficiency and quality with the least energy expenditure.
The spastic threshold rate is defined as the minimum rate at which spastic response is observed during controlled open chain measurements. It is estimated that the spastic threshold rate decreases as the severity of stroke increases in stroke patients. However, the relationship between the onset of stretch-induced muscle activation and the resistance (catching) felt by clinicians in stroke survivors has not been fully investigated. Also, it is not clear whether the catch angle also depends on the joint angle position. Spasticity is clinically related to speed, joint position, angle of capture, etc. should be revealed quickly, rehabilitation practices should be made specific to the person and the activity. By raising the spastic rate threshold, the emergence of spasticity in the early phase should be prevented, even at higher velocities. In the management of spasticity, with a current point of view, classical rehabilitation practices should be avoided and motor learning strategies specific to the patient should be introduced. In this sense, our study was planned to investigate the effect of speed-based motor learning training on spasticity characteristics and balance activities in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Traditional Rehabilitation Group | Experimental | Other: Speed-based relearning trainingThis group will receive a 6-week neurorehabilitation program that includes stretching for spasticity inhibition, strengthening of the antagonist muscle, autogenic inhibition methods, as well as conscious-unconscious balance training and gait training, which are routinely applied in physical therapy and rehabilitation units. The treatment will be applied 5 days a week. In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions |
| Study-Neurodevelopmental Therapy Group | Experimental | Other: Neurodevelopmental TherapyFunction-oriented Neurodevelopmental Therapy will be applied to the subjects included in the study and randomly assigned to the study group in different positions such as supine, prone, sitting, standing for 6 weeks, 5 sessions per week, and the goal will be to achieve the task at different speeds. Spasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Post-stroke hemiparetic-hemiplegic clinical picture
- Getting 0-3 points according to the Modified Rankin Scale
- Brunnstorm lower extremity stage≥ 2
- Getting a score of 24 or higher on the Mini Mental test
- Being clinically stable
Key exclusion criteria (2 listed)
- Not having spasticity
- Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke
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 |
|---|---|---|
| Speed-based relearning trainingSpasticity, balance and gait exercises will be started at slow speeds, at muscle level, and in the following sessions, movement speed will be increased in relation to the patient's compliance, and global balance and gait exercises will be performed. | Other | Control-Traditional Rehabilitation Group |
| Neurodevelopmental TherapyNeurodevelopmental Therapy | Other | Study-Neurodevelopmental Therapy Group |
Primary outcome
Modified Tardieu Scale
Time frame: 6 weeks
The scale evaluates spasticity from three different rates in order to evaluate the rate-dependent effect of spasticity. These speeds are defined as speeds V1, V2 and V3. The speed V1 represents the evaluation at the lowest speed, and V3 represents the evaluation at the highest speed. In all 3 speeds, the target joints are moved passively through the full range of motion and the range of values in which spasticity is observed is calculated by means of a goniometer.
Berg Balance Scale
Time frame: 6 weeks
It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently.
Time Up and Go Test
Time frame: 6 weeks
The person is asked to get up from the chair he is sitting in, walk 3 meters at a safe and normal pace, turn, walk back and sit back in the chair. The time it takes to complete the test is recorded in seconds.
Portable computerized kinesthetic balance device (SportKAT 550)
Time frame: 6 weeks
The device consists of two parts, an electronic tilt sensor and a moving platform. The electronic sensor evaluates the movement of the platform during the test period and transfers the data to the connected computer. The computer screen is placed 1 meter in front of the people and at eye level to provide feedback to the people. The computer screen has a red cross indicating the movement of the platform. The evaluated person tries to keep this sign on the screen in the center for 30 seconds. At the end of the test, the device calculates a balance score. This score shows how close the person holds the platform to the reference position. At the end of the test, scores ranging from 0 to 6000 are formed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed-based relearning training and Neurodevelopmental Therapy in people with Stroke and Spasticity, Muscle, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Duray (+902462113268, mehmetduray@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Tardieu Scale (time frame: 6 weeks). 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?
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 25 Feb 2022.