"Core Stability" Exercises to Improve Sitting Balance in Stroke Patients

NCT01864382 | Completed DMC

• 1 other identifier: UIC-FIS-2012-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The stroke as cerebrovascular disease is the leading cause of permanent neurological disability and the third death in the Western world. Their affected often have motor and sensory disturbances in the form of hemiparesis with a possible influence on the balance be altered trunk muscles, important components of postural control. The treatment of stroke, covers a wide range of different strategies and approaches physiotherapy, including, specific exercises on the trunk called "core stability", performed by the patient with the help and supervision of a physiotherapist specializing in neurology, that are based on coordination, motor and proprioceptive work, especially the lumbar-pelvic. The effectiveness of these last years has been demonstrated empirically, but until now there is no sufficient evidence of the effects of these exercises on sitting balance in respect, and standing up in the subacute phase post-stroke patients. To prove the evidence raises a randomized, multicenter, blinded and where the evaluator will not participate in the analysis and processing is done by intention to treat. Patients will be divided into two groups: control (usual physiotherapy center made ) and experimental (made also 15 minutes workout "core stability"). The intervention will have a frequency of 5 days a week for 5 weeks and up to 12 weeks. The expected effect is that the experimental group patients develop better postural control at the trunk and this influences the balance in sitting, standing and walking.

Conditions

Stroke; Cerebral Stroke; Cerebrovascular Accident

Keywords

Trunk performance; exercise,; "core stability",; sitting balance

Outcome Measures

Primary Outcomes (1)

• Dynamic sitting balance

  Trunk Impairment Scales:Is a tool to measure the motor impairment of the trunk after stroke, This scale evaluates dynamic sitting balance as well as co-ordination of trunk movement.

  Baseline, up to 25 sessions and follow up to 24 weeks

Secondary Outcomes (1)

• Standing balance

  Baseline, up to 25 sessions and follow up to 24 weeks

Other Outcomes (1)

• Mobility and degree of disability

  Baseline, up to 25 sessions and follow up to 24 weeks

Study Arms (2)

Standard Physiotherapy Exercises

OTHER

Standard Physiotherapy Exercises 5 days a week during 5 weeks

Other: Standard Physiotherapy Exercises

Core stability

EXPERIMENTAL

Core stability.5 days a week during 5 weeks

Other: Core stability; Other: Standard Physiotherapy Exercises

Interventions

Core stability OTHER

Core stability 5 days a week during 5 weeks

Also known as: Trunk exercises

Core stability

Standard Physiotherapy Exercises OTHER

Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks

Also known as: Usual care

Core stability; Standard Physiotherapy Exercises

Eligibility Criteria

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

You may qualify if:

• Adults of either sex
• \> 18 years with a diagnosis of stroke, ischemic or hemorrhagic origin \<3 months of evolution
• Orthopedic problems not present to keep sitting. Ability to understand instructions
• The Index Barthel ˂ 70 points and Trunk Impairment Scale ˂ 16 points.

You may not qualify if:

• Patients with cognitive problems, Mini mental state examination ˂ 24
• Patients with a second stroke confirmed by Neurology services or previous motor disability that altered the balance, or a Rankin value not superior to 3
• The patients with stroke hemorrhagic origin with surgical treatment.

Sponsors & Collaborators

• Rosa Cabanas Valdés: lead
• Corporacion Parc Tauli: collaborator
• Institut Investigacio Sanitaria Pere Virgili: collaborator

Study Sites (2)

Parc Sanitari Pere Virgili

Barcelona, Catalonia, 08023, Spain

Location

Consorci Hospitalari Parc Tauli

Sabadell Barcelona, Catalonia, 08208, Spain

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Core Stability

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Postural Balance; Proprioception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensation; Nervous System Physiological Phenomena

Study Officials

• Rosa Mª Cabanas-Valdes, Kinesiology

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

• Caritat Bagur-Calafat

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of the Physical Therapy teaching staff

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 29, 2013
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

ES (2)