Effectiveness of Core Stability Training on Trunk Control in Patients With Post-hemorrhagic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- University of Cagliari
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Change from Baseline Trunk Impairment Scale at 8 weeks and 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: General exercise programme (Other)
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).
Intervention: Interventional programme (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change from Baseline Short-Form Health Survey Questionnaire at 8 weeks and 12 months(Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up))
- Change from Baseline Functional Independence Measure (FIM) at 8 weeks and 12 months(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(Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up))
- Global Perceived Effect(eight weeks after starting treatment (post-treatment))
Investigators
Marco Monticone
Professor
University of Cagliari