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

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.

Study Overview

• Status: Suspended
• Conditions: Hemorrhagic Stroke
• Intervention / Treatment: Other: Interventional programme; Other: General exercise programme

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cagliari, Italy, 09100
    • University of Cagliari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	eight weeks after starting treatment (post-treatment)

Collaborators and Investigators

• Sponsor: University of Cagliari
• Investigators: Study Chair: Marco Monticone, MD, PhD, University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hemorrhagic Stroke, Trunk Impairment, Core Stability
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: PG/2021/17872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No