StrokeNCT04753931
Effects of Sensory Training Application in Addition to Bobath Training
A study testing Sensory Training in addition to Bobath Training and Bobath Training in people with Stroke and Stroke Rehabilitation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Stroke Rehabilitation
- What is being tested?
- Sensory Training in addition to Bobath Training and Bobath Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 May 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sub-acute (more than three months) and chronic stroke patients.
- Patients are older than 18 years.
- Patients who can sit and walk independently (including those using a walking aid).
Who cannot join
- Patients with a total score of 20 or more on the trunk impairment scale.
- Patients with additional neurological and/or orthopedic problems that may affect motor performance and balance.
- Patients with mental problems (Mini-Mental State Examination test score <23).
- Patients with communication problems.
- Recurrent stroke patients.
- Patients aged 85 years and over.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Sensory Training Application in Addition to Bobath Training in Stroke Rehabilitation on Balance, Walking and Trunk Position Sensation
The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. The secondary aim of the study is to investigate the effects of Bobath-based and trunk-focused exercises on trunk functional capacity, balance and gait performance.
Our study consists of two groups: Bobath-based trunk training group and, sensory training group in addition to Bobath-based trunk training. The information of individuals who agree to participate in the study and meet the criteria for admission to the study will be recorded with a demographic information form. The scales, questionnaires and tests determined to evaluate the individual's trunk position sense and functions, balance and walking performance will be applied before and after the study.
Read the detailed description
According to the definition of the World Health Organization, stroke is a clinical scene that develops due to vascular causes, causes focal or global brain damage, begins acutely, and progresses with neurological symptoms lasting 24 hours or longer. İt is stated that stroke is the third leading cause of disability worldwide. As a result of stroke, sensory disturbances may occur in individuals as well as motor symptoms.
The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. The secondary aim of the study is to investigate the effects of Bobath-based and trunk-focused exercises on trunk functional capacity, balance and gait performance.
Our study consists of two groups: Bobath-based trunk training group and, sensory training group in addition to Bobath-based trunk training. All participants will be randomly distributed (using software at http://www.randomizer.org). First, 12 patients will be included in our study and the total number of patients will be determined by calculating the effect size with the interm analysis to be performed later. Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks and 24 sessions in total. Exercises will be applied to the individuals after conventional therapy session. The information of individuals who agree to participate in the study and meet the criteria for admission to the study will be recorded with a demographic information form. The scales, questionnaires and tests determined to evaluate the individual's trunk position sense and functions, balance and walking performance will be applied before and after the study.
- Conditions
- Stroke, Stroke Rehabilitation
- Being tested
- Sensory Training in addition to Bobath Training, Bobath Training
- Keywords
- Stroke Rehabilitation, Bobath, Trunk İmpairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Training in addition to Bobath TrainingOther
Trunk-focused exercises will be applied for different senses (tactile, proprioceptive, etc.) in addition to Bobath exercises. Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected.
Bobath TrainingOther
Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Training in addition to Bobath Training | Experimental | Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions. Receives: Other: Sensory Training in addition to Bobath Training |
| Bobath Training | Experimental | Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions. Receives: Other: Bobath Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
This scale aims to evaluate the trunk in patients who have suffered a stroke.
Measured: The evaluation will be applied at the beginning of the treatment program.
Trunk Impairment Scale
This scale aims to evaluate the trunk in patients who have suffered a stroke.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
The Stroke Rehabilitation Assessment of Movement (STREAM)
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
Measured: The evaluation will be applied at the beginning of the treatment program.
The Stroke Rehabilitation Assessment of Movement (STREAM)
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
The Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Measured: The evaluation will be applied at the beginning of the treatment program.
The Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Measured: The evaluation will be applied at the beginning of the treatment program.
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
The Barthel Scale/Index (BI)
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Measured: The evaluation will be applied at the beginning of the treatment program.
The Barthel Scale/Index (BI)
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
The Stroke Specific Quality of Life scale (SS-QOL)
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Measured: The evaluation will be applied at the beginning of the treatment program.
The Stroke Specific Quality of Life scale (SS-QOL)
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
Functional Reach Test (FRT)
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
Measured: The evaluation will be applied at the beginning of the treatment program.
Functional Reach Test (FRT)
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
2 Minute Walk Test (2MWT)
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Measured: The evaluation will be applied at the beginning of the treatment program.
2 Minute Walk Test (2MWT)
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
Mini-Mental State Examination
The Mini-mental state examination is used to measure cognitive impairment.
Measured: The evaluation will be applied at the beginning of the treatment program.
Trunk position sense measurements
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
Measured: The evaluation will be applied at the beginning of the treatment program.
Trunk position sense measurements
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
Measured: The evaluation will be applied at the end of the 8 weeks treatment program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Mar 2021
- Primary completion15 May 2022
- Study completion30 May 2022
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Karaca, M.Sc., Study chair, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753931
- Sponsor's protocol ID
- KaratayUOK
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Sensory Training Application in Addition to Bobath Training in Stroke Rehabilitation on Balance, Walking and Trunk Position Sensation
- ClinicalTrials.gov ID
- NCT04753931
- Acronym / sponsor ID
- KaratayUOK
- Conditions
- Stroke, Stroke Rehabilitation
- Keywords
- Stroke Rehabilitation, Bobath, Trunk İmpairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 15 Feb 2021 (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.
The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. The secondary aim of the study is to investigate the effects of Bobath-based and trunk-focused exercises on trunk functional capacity, balance and gait performance.
Our study consists of two groups: Bobath-based trunk training group and, sensory training group in addition to Bobath-based trunk training. The information of individuals who agree to participate in the study and meet the criteria for admission to the study will be recorded with a demographic information form. The scales, questionnaires and tests determined to evaluate the individual's trunk position sense and functions, balance and walking performance will be applied before and after the study.
Detailed description
According to the definition of the World Health Organization, stroke is a clinical scene that develops due to vascular causes, causes focal or global brain damage, begins acutely, and progresses with neurological symptoms lasting 24 hours or longer. İt is stated that stroke is the third leading cause of disability worldwide. As a result of stroke, sensory disturbances may occur in individuals as well as motor symptoms.
The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. The secondary aim of the study is to investigate the effects of Bobath-based and trunk-focused exercises on trunk functional capacity, balance and gait performance.
Our study consists of two groups: Bobath-based trunk training group and, sensory training group in addition to Bobath-based trunk training. All participants will be randomly distributed (using software at http://www.randomizer.org). First, 12 patients will be included in our study and the total number of patients will be determined by calculating the effect size with the interm analysis to be performed later. Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks and 24 sessions in total. Exercises will be applied to the individuals after conventional therapy session. The information of individuals who agree to participate in the study and meet the criteria for admission to the study will be recorded with a demographic information form. The scales, questionnaires and tests determined to evaluate the individual's trunk position sense and functions, balance and walking performance will be applied before and after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Training in addition to Bobath Training | Experimental | Other: Sensory Training in addition to Bobath TrainingExercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions. |
| Bobath Training | Experimental | Other: Bobath TrainingExercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sub-acute (more than three months) and chronic stroke patients.
- Patients are older than 18 years.
- Patients who can sit and walk independently (including those using a walking aid).
Key exclusion criteria (6 listed)
- Patients with a total score of 20 or more on the trunk impairment scale.
- Patients with additional neurological and/or orthopedic problems that may affect motor performance and balance.
- Patients with mental problems (Mini-Mental State Examination test score <23).
- Patients with communication problems.
- Recurrent stroke patients.
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 |
|---|---|---|
| Sensory Training in addition to Bobath TrainingTrunk-focused exercises will be applied for different senses (tactile, proprioceptive, etc.) in addition to Bobath exercises. Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected. | Other | Sensory Training in addition to Bobath Training |
| Bobath TrainingBobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected. | Other | Bobath Training |
Primary outcome
Trunk Impairment Scale
Time frame: The evaluation will be applied at the beginning of the treatment program.
This scale aims to evaluate the trunk in patients who have suffered a stroke.
Trunk Impairment Scale
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
This scale aims to evaluate the trunk in patients who have suffered a stroke.
The Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: The evaluation will be applied at the beginning of the treatment program.
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
The Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
The Fugl-Meyer Assessment (FMA)
Time frame: The evaluation will be applied at the beginning of the treatment program.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
The Fugl-Meyer Assessment (FMA)
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Berg Balance Scale
Time frame: The evaluation will be applied at the beginning of the treatment program.
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Berg Balance Scale
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
The Barthel Scale/Index (BI)
Time frame: The evaluation will be applied at the beginning of the treatment program.
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
The Barthel Scale/Index (BI)
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
The Stroke Specific Quality of Life scale (SS-QOL)
Time frame: The evaluation will be applied at the beginning of the treatment program.
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
The Stroke Specific Quality of Life scale (SS-QOL)
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Functional Reach Test (FRT)
Time frame: The evaluation will be applied at the beginning of the treatment program.
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
Functional Reach Test (FRT)
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
2 Minute Walk Test (2MWT)
Time frame: The evaluation will be applied at the beginning of the treatment program.
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
2 Minute Walk Test (2MWT)
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Mini-Mental State Examination
Time frame: The evaluation will be applied at the beginning of the treatment program.
The Mini-mental state examination is used to measure cognitive impairment.
Trunk position sense measurements
Time frame: The evaluation will be applied at the beginning of the treatment program.
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
Trunk position sense measurements
Time frame: The evaluation will be applied at the end of the 8 weeks treatment program.
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
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 31 Oct 2023.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Osman Karaca, M.Sc. study chair
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Training in addition to Bobath Training and Bobath Training in people with Stroke and Stroke Rehabilitation, run by KTO Karatay 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 3 inclusion and 6 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 31 Oct 2023. 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?
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?
Trunk Impairment Scale (time frame: The evaluation will be applied at the beginning of the treatment program.). The study lists 19 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 31 Oct 2023.