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CompletedNCT01864382FisionetUpdated May 24, 2021

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

An interventional study of Core stability and Standard Physiotherapy Exercises in Stroke, Cerebral Stroke and Cerebrovascular Accident, sponsored by Rosa Cabanas Valdés. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-24.

Sponsored by Rosa Cabanas Valdés · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The deterioration in the balance sitting and poor sitting ability, clinical problems are common after stroke. These patients show a significant decrease in the performance level of the trunk, compared to healthy individuals of the same age and sex and present asymmetry of the trunk and pelvis.

Sitting involves the ability to achieve a variety of objects that are in and out of arm's length, as personal daily activities, showering, going to the bathroom and dressing. These arm movements, triggering postural adjustments in the muscles of the trunk and lower extremities, which anticipated the movement always precede the active movement. This anticipative control can be altered in subjects with stroke.

The trunk seems particularly important for balance, as stabilizes the pelvis and spine. Dean et al, (1997; 2007) and Ibrahimi (2010) showed a beneficial effect on functional scope of practice tasks, sitting in variables dynamic sitting balance, load weight of the affected side and standing. Also in the studies of Howe (2005); Verheyden (2009); Saeys (2011);Karthikbabu (2011) and Kumar (2011) with specific exercises for the trunk, favorable outcomes were obtained compared with standard treatment. However, these studies with few patients and without any monitoring, it needs to be confirmed (what is this study intended)

02

Conditions studied

  • Stroke
  • Cerebral Stroke
  • Cerebrovascular Accident

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Keywords

  • Trunk performance
  • exercise,
  • "core stability",
  • sitting balance
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Rosa Cabanas Valdés as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Other
    Standard Physiotherapy Exercises

    Standard Physiotherapy Exercises 5 days a week during 5 weeks

    Other: Standard Physiotherapy Exercises

  • Experimental
    Core stability

    Core stability.5 days a week during 5 weeks

    Other: Core stability · Other: Standard Physiotherapy Exercises

Interventions

  • OtherCore stability

    Core stability 5 days a week during 5 weeks

    Also known as: Trunk exercises

  • OtherStandard Physiotherapy Exercises

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

    Also known as: Usual care

06

What researchers measure

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.

    Time frame: Baseline, up to 25 sessions and follow up to 24 weeks

Secondary outcomes

  1. Standing balance

    Berg Balance Scale (BBS)assesses standing balance. This scale includes 14 common tasks of ability to maintain positions or movements of increasing difficulty by decreasing base of support from sit, to stand, to single-limb support.Each of the 14 tasks is scored on a scale from 0 (worst) to 4 (best) for a total score of 56.

    Time frame: Baseline, up to 25 sessions and follow up to 24 weeks

Other outcomes

  1. Mobility and degree of disability

    The Barthel index is a valid scale for studying function in stroke patients.The initial Barthel score is an important prognostic factor for both recovery of function and for survival. The scale consists 10 items.

    Time frame: Baseline, up to 25 sessions and follow up to 24 weeks

07

Study locations

2 sites
  • Parc Sanitari Pere Virgili
    Barcelona, Catalonia 08023, Spain
  • Consorci Hospitalari Parc Tauli
    Sabadell Barcelona, Catalonia 08208, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01864382
Lead sponsor
Rosa Cabanas Valdés
Collaborators
Corporacion Parc Tauli, Institut Investigacio Sanitaria Pere Virgili
Responsible party
Rosa Cabanas Valdés (Instructor of the Physical Therapy teaching staff, Universitat Internacional de Catalunya) — Sponsor-investigator
First posted
May 29, 2013
Start date
Oct 2012
Primary completion
Sep 2014
Completion
Sep 2014
Last update
May 24, 2021

Study contacts

Rosa Mª Cabanas-Valdes, Kinesiology
principal investigator · Universitat Internacional de Catalunya
Caritat Bagur-Calafat
study director · Universitat Internacional de Catalunya

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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