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Effectiveness of Core Stability Training on Trunk Control in Patients With Post-hemorrhagic Stroke

U

University of Cagliari

Status

Suspended

Conditions

Hemorrhagic Stroke

Treatments

Other: Interventional programme
Other: General exercise programme

Study type

Interventional

Funder types

Other

Identifiers

NCT05207345
PG/2021/17872

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

86 participants in 2 patient groups

Experimental Group
Experimental group
Description:
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).
Treatment:
Other: Interventional programme
General Group
Active Comparator group
Description:
90 minutes of general rehabilitation (active / active assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training).
Treatment:
Other: General exercise programme

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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