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

NCT05207345 | Suspended

• 1 other identifier: PG/2021/17872
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Stroke

Keywords

Hemorrhagic Stroke, Trunk Impairment, Core Stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• 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)

• Global Perceived Effect

  eight weeks after starting treatment (post-treatment)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

General Group

ACTIVE COMPARATOR

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

Interventions

Interventional programme OTHER

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).

Experimental Group

General exercise programme OTHER

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

General Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Cagliari

Cagliari, 09100, Italy

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marco Monticone, MD, PhD

  University of Cagliari

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 26, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)