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

Primary Purpose

Hemorrhagic Stroke

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Interventional programme
General exercise programme
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Stroke focused on measuring Hemorrhagic Stroke, Trunk Impairment, Core Stability

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Cagliari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

General Group

Arm 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).

90 minutes of general rehabilitation (active / active assisted / passive mobilization, stretching, posture maintenance, postural and autonomy training, cycle ergometer, exercise bike and ambulatory training).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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).
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).

Full Information

First Posted
January 11, 2022
Last Updated
May 24, 2022
Sponsor
University of Cagliari
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1. Study Identification

Unique Protocol Identification Number
NCT05207345
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke
Keywords
Hemorrhagic Stroke, Trunk Impairment, Core Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm 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).
Arm Title
General Group
Arm Type
Active Comparator
Arm 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).
Intervention Type
Other
Intervention Name(s)
Interventional programme
Intervention 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).
Intervention Type
Other
Intervention Name(s)
General exercise programme
Intervention 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).
Primary Outcome Measure Information:
Title
Change from Baseline Trunk Impairment Scale at 8 weeks and 12 months
Description
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
Time Frame
Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Secondary Outcome Measure Information:
Title
Change from Baseline Functional Independence Measure (FIM) at 8 weeks and 12 months
Description
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.
Time Frame
Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Title
Change from Baseline Berg Balance Scale (BBS) at 8 weeks and 12 months
Description
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).
Time Frame
Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Title
Change from Baseline Short-Form Health Survey Questionnaire at 8 weeks and 12 months
Description
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).
Time Frame
Questionnaires will be administered before treatment, eight weeks after (post-treatment) and 12 months after the end of treatment (follow-up)
Title
Global Perceived Effect
Description
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).
Time Frame
eight weeks after starting treatment (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Monticone, MD, PhD
Organizational Affiliation
University of Cagliari
Official's Role
Study Chair
Facility Information:
Facility Name
University of Cagliari
City
Cagliari
ZIP/Postal Code
09100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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