Clinical trial NCT05207345: Effectiveness of Core Stability Training on Trunk Control in Patients With Post-hemorrhagic Stroke
Official title: Effectiveness of Core Stability Training on Trunk Control in Patients With Post-hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hemorrhagic Stroke
Keywords: Hemorrhagic Stroke, Trunk Impairment, Core Stability
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* haemorrhagic stroke \< 3 months, first event
* adulthood (40-75 years)
* ability to maintain the sitting position
* good knowledge of the Italian language

Exclusion Criteria:

* cognitive impairment
* Ashworth score\> 2
* Neurodegenerative and/or neuromuscular disorders
* Severe cardiovascular and respiratory instability, systemic diseases

Primary outcomes:
measure: Change from Baseline Trunk Impairment Scale at 8 weeks and 12 months
timeFrame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Secondary outcomes:
measure: Change from Baseline Functional Independence Measure (FIM) at 8 weeks and 12 months
timeFrame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
measure: Change from Baseline Berg Balance Scale (BBS) at 8 weeks and 12 months
timeFrame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
measure: Change from Baseline Short-Form Health Survey Questionnaire at 8 weeks and 12 months
timeFrame: Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
measure: Global Perceived Effect
timeFrame: eight weeks after starting treatment (post-treatment)
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: University of Cagliari
Study officials:
affiliation: University of Cagliari
name: Marco Monticone, MD, PhD
role: STUDY_CHAIR
References: