Hemorrhagic StrokeNCT05207345
Effectiveness of Core Stability Training on Trunk Control in Patients With Post-hemorrhagic Stroke
A study testing Interventional programme and General exercise programme in people with Hemorrhagic Stroke, run by University of Cagliari at 1 site in Italy.
Trial summary
Stroke is responsible for about 7% of disabilities in the European population. Intracerebral hemorrhage (ICH) represents 15% of stroke cases in Europe. In order to avoid disabling sequelae, an essential role is played by early rehabilitation, which has also proved effective for ICH. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hemorrhagic Stroke
- What is being tested?
- Interventional programme and General exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 30 Dec 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- haemorrhagic stroke < 3 months, first event
- adulthood (40-75 years)
- ability to maintain the sitting position
- good knowledge of the Italian language
Who cannot join
- cognitive impairment
- Ashworth score> 2
- Neurodegenerative and/or neuromuscular disorders
- Severe cardiovascular and respiratory instability, systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is responsible for about 7% of disabilities in the European population. Intracerebral hemorrhage (ICH) represents 15% of stroke cases in Europe. In order to avoid disabling sequelae, an essential role is played by early rehabilitation, which has also proved effective for ICH.
In addition to its role in physical recovery, it plays a fundamental role in the psychological well-being of patients with ICH.
Read more
Impairments in trunk function are a common sequela and are related to reduced mobility, balance and functional independence.
Trunk exercises could improve trunk control, postural control, and functional recovery.
The hypothesis is that a specific exercise program, based on core stability, will induce clinically significant and long-term improvements from the point of view of trunk control, and secondly in postural control, disability and quality of life in subjects with hemorrhagic stroke outcomes, versus general physiotherapy, and that these improvements will be maintained at least one year after the intervention.
Read the detailed description
Stroke is responsible for about 7% of disabilities in the European population, and in particular intracerebral hemorrhage (ICH), whose mortality is higher than ischemic stroke, represents 15% of stroke cases in Europe.
In order to avoid disabling sequelae, an essential role is played by early rehabilitation, which has also proved effective for ICH.
Patients undergoing early rehabilitation within neurorehabilitation units achieve better clinical-functional outcomes than those who receive general medical care; furthermore, in addition to its role in physical recovery, it plays a fundamental role in the psychological well-being of patients with ICH, as these patients tend to be less depressed and anxious than those undergoing standard care.
However, even after intensive rehabilitation functional deficits still exist, making stroke the leading cause of disability in adults globally.
Impairments in trunk function, in particular, are a common sequelae and are related to reduced mobility, balance and functional independence. Therefore, impairments in trunk function can lead to limitations of activity and participation, as well as to increase the risk of falling resulting in further disability, hospitalization and mortality.
The dysfunction of the core, which would significantly affect the function of the trunk, would seem to be linked to a reduction in muscle strength, to a delayed/asymmetrical activation of the muscles, as well as to proprioceptive alterations.
Following this line, trunk exercises could then improve trunk control, postural control, and functional recovery.
Looking at the literature, it has been seen how several randomized controlled trials have focused on the efficacy of trunk training in stroke populations with positive and encouraging results regarding the outcomes achieved within the experimental groups. However, these studies, in addition to including patients with both ischemic and haemorrhagic stroke, did not always equalize the amount of exercise provided with a control group, showing heterogeneity in the exercises administered, and did not consider whether the therapeutic efficacy observed at the end of the treatment is still maintained over the long term.
The hypothesis is that a specific exercise program, based on core stability, will induce clinically significant and long-term improvements from the point of view of trunk control, and secondly in postural control, disability and quality of life in subjects with hemorrhagic stroke outcomes, versus general physiotherapy, and that these improvements will be maintained at least one year after the intervention.
- Conditions
- Hemorrhagic Stroke
- Being tested
- Interventional programme, General exercise programme
- Keywords
- Hemorrhagic Stroke, Trunk Impairment, Core Stability
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional programmeOther
90-minute session divided into:
- 45 minutes of "core stability" treatment
- 45 minutes of general rehabilitation (active / active, assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training).
General exercise programmeOther
90 minutes of general rehabilitation (active / active assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 90-minute session divided into:
* 45 minutes of "core stability" treatment
* 45 minutes of general rehabilitation (active / active, assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training). Receives: Other: Interventional programme |
| General Group | Active comparator | 90 minutes of general rehabilitation (active / active assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training). Receives: Other: General exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Trunk Impairment Scale at 8 weeks and 12 months
The Trunk Impairment Scale (TIS) is a 17-item scale that aims to assess the static, dynamic balance and coordination of the trunk. Each item is given a variable score from 0 to 3 in relation to the performance analyzed. The final score can range from a minimum of 0 points to a maximum of 23. The higher the score, the more independent the patient is in performing trunk control. Investigators used the Italian version which proved to be reliable and valid
Measured: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Secondary outcomes (4)
Change from Baseline Functional Independence Measure (FIM) at 8 weeks and 12 months
FIM describes 18 Activities of daily living (ADLs) associated with motor, cognitive, and sphincteral problems and ranges from 18 (maximal limitation) to 126 (no limitation).
Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
Measured: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Change from Baseline Berg Balance Scale (BBS) at 8 weeks and 12 months
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function Final score ranges from 0 (high risk of falling) to 56 (no risk of falling).
Measured: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Change from Baseline Short-Form Health Survey Questionnaire at 8 weeks and 12 months
Quality of life is assessed using the Italian version of the self-report Short-Form Health Survey with its eight domain scores ranging from 0 (the worst perceived quality of life) to 100 (the best perceived quality of life).
Measured: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Global Perceived Effect
Global Perceived Effect is a self-administered measure of treatment satisfaction consisting of a five-level Likert scale (1=helped a lot, 2=helped, 3=helped only a little, 4=did not help, 5=made things worse).
Measured: eight weeks after starting treatment (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Dec 2024 (estimated)
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Monticone, University of Cagliari
- Investigators
- Marco Monticone, MD, PhD, Study chair, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207345
- Sponsor's protocol ID
- PG/2021/17872
- Status last verified
- Nov 2023
- First submitted
- 11 Jan 2022
- Last updated
- 4 Dec 2023
- Results posted
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Core Stability Training on Trunk Control in Patients With Post-hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT05207345
- Acronym / sponsor ID
- PG/2021/17872
- Conditions
- Hemorrhagic Stroke
- Keywords
- Hemorrhagic Stroke, Trunk Impairment, Core Stability
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of resources
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Jan 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.
Stroke is responsible for about 7% of disabilities in the European population. Intracerebral hemorrhage (ICH) represents 15% of stroke cases in Europe. In order to avoid disabling sequelae, an essential role is played by early rehabilitation, which has also proved effective for ICH.
In addition to its role in physical recovery, it plays a fundamental role in the psychological well-being of patients with ICH.
Impairments in trunk function are a common sequela and are related to reduced mobility, balance and functional independence.
Trunk exercises could improve trunk control, postural control, and functional recovery.
The hypothesis is that a specific exercise program, based on core stability, will induce clinically significant and long-term improvements from the point of view of trunk control, and secondly in postural control, disability and quality of life in subjects with hemorrhagic stroke outcomes, versus general physiotherapy, and that these improvements will be maintained at least one year after the intervention.
Detailed description
Stroke is responsible for about 7% of disabilities in the European population, and in particular intracerebral hemorrhage (ICH), whose mortality is higher than ischemic stroke, represents 15% of stroke cases in Europe.
In order to avoid disabling sequelae, an essential role is played by early rehabilitation, which has also proved effective for ICH.
Patients undergoing early rehabilitation within neurorehabilitation units achieve better clinical-functional outcomes than those who receive general medical care; furthermore, in addition to its role in physical recovery, it plays a fundamental role in the psychological well-being of patients with ICH, as these patients tend to be less depressed and anxious than those undergoing standard care.
However, even after intensive rehabilitation functional deficits still exist, making stroke the leading cause of disability in adults globally.
Impairments in trunk function, in particular, are a common sequelae and are related to reduced mobility, balance and functional independence. Therefore, impairments in trunk function can lead to limitations of activity and participation, as well as to increase the risk of falling resulting in further disability, hospitalization and mortality.
The dysfunction of the core, which would significantly affect the function of the trunk, would seem to be linked to a reduction in muscle strength, to a delayed/asymmetrical activation of the muscles, as well as to proprioceptive alterations.
Following this line, trunk exercises could then improve trunk control, postural control, and functional recovery.
Looking at the literature, it has been seen how several randomized controlled trials have focused on the efficacy of trunk training in stroke populations with positive and encouraging results regarding the outcomes achieved within the experimental groups. However, these studies, in addition to including patients with both ischemic and haemorrhagic stroke, did not always equalize the amount of exercise provided with a control group, showing heterogeneity in the exercises administered, and did not consider whether the therapeutic efficacy observed at the end of the treatment is still maintained over the long term.
The hypothesis is that a specific exercise program, based on core stability, will induce clinically significant and long-term improvements from the point of view of trunk control, and secondly in postural control, disability and quality of life in subjects with hemorrhagic stroke outcomes, versus general physiotherapy, and that these improvements will be maintained at least one year after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Interventional programme90-minute session divided into: * 45 minutes of "core stability" treatment * 45 minutes of general rehabilitation (active / active, assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training). |
| General Group | Active comparator | Other: General exercise programme90 minutes of general rehabilitation (active / active assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- haemorrhagic stroke < 3 months, first event
- adulthood (40-75 years)
- ability to maintain the sitting position
- good knowledge of the Italian language
Key exclusion criteria (4 listed)
- cognitive impairment
- Ashworth score> 2
- Neurodegenerative and/or neuromuscular disorders
- Severe cardiovascular and respiratory instability, systemic diseases
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 |
|---|---|---|
| Interventional programme90-minute session divided into: * 45 minutes of "core stability" treatment * 45 minutes of general rehabilitation (active / active, assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training). | Other | Experimental Group |
| General exercise programme90 minutes of general rehabilitation (active / active assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training). | Other | General Group |
Primary outcome
Change from Baseline Trunk Impairment Scale at 8 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
The Trunk Impairment Scale (TIS) is a 17-item scale that aims to assess the static, dynamic balance and coordination of the trunk. Each item is given a variable score from 0 to 3 in relation to the performance analyzed. The final score can range from a minimum of 0 points to a maximum of 23. The higher the score, the more independent the patient is in performing trunk control. Investigators used the Italian version which proved to be reliable and valid
4 secondary outcomes
Change from Baseline Functional Independence Measure (FIM) at 8 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Change from Baseline Berg Balance Scale (BBS) at 8 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Change from Baseline Short-Form Health Survey Questionnaire at 8 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Global Perceived Effect
Time frame: eight weeks after starting treatment (post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Hemorrhagic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Marco Monticone, MD, PhD study chair
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional programme and General exercise programme in people with Hemorrhagic Stroke, run by University of Cagliari at 1 site in Italy.
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 4 inclusion and 4 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: paused, as of the sponsor's last update on 4 Dec 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 Italy. 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?
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?
Change from Baseline Trunk Impairment Scale at 8 weeks and 12 months (time frame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)). 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 4 Dec 2023.