Brain Injury, VascularCORENCT03975985

The Effectiveness of Core Stability Exercises

A study testing Core stability exercises (CSE) and Conventional Physiotherapy in people with Brain Injury, Vascular and Sequelae, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study assess the effectiveness of core stability exercises performed in subacute phase of stroke. Half of participants will receive conventional physiotherapy, while the other half will receive core stability exercises and core stability exercises plus transcutaneous electrical nerve stimulation (TENS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Injury, Vascular, Sequelae, Stroke Syndrome
What is being tested?: Core stability exercises (CSE) and Conventional Physiotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteSpain
Study dates: 15 Jan 2019to 15 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

First ever stroke same and less than 30 days (diagnostic criteria according to the World Health Organization definition; corresponding to ICD-9 code 434) weather cortical or subcortical, and ischemic or haemorrhagic.
Unilateral localization of the stroke verified by computed tomography (CT).
More or equal than18 years.
Ability to understand and execute simple instructions.
Spanish Version of Trunk Impairment Scale.2.0 less than10 points.
National institute of Health Stroke Scale (NIHSS) score > 4 points.

Who cannot join

Rankin scale more or equal than 2 points before stroke.
Orthopaedic and other neurological disorders that hamper sitting balance.
Relevant psychiatric disorders that may prevent from following instructions.
Other treatments that could influence the effects of the interventions.
Contraindication to physical activity (e.g., heart failure).
Using cardiac pacemakers.
Moderate to severe cognitive impairments as indicated by Minimental test score < 24 points.
Patients with haemorrhagic stroke that have undergone surgery.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Barcelona, Catalonia, 08025

Other trials in Spain

About this study

Official title: The Effect of Additional Core Stability Exercises on Improving Dynamic Sitting Balance, Trunk Control and Functional Rehabilitation for Subacute Stroke Patients: A Randomized Controlled Trial

Read the detailed description

Background: The majority of subjects who have suffered a first-time stroke have balance disability in the subacute phase. Trunk impairment, restricted balance, and impaired postural control in patients with stroke are correlated with increasing risk of falls and impaired mobility. This creates disability and dependency in their activities of daily living. The core is central to almost all kinetic chains in the body. Several studies and a systematic review have shown that implementing core stability exercises may be a viable strategy for improving trunk performance and dynamic sitting balance, standing balance, and gait in post-stroke patients.

Main objective: To compare the efficacy of conventional physiotherapy versus an approach based on a Core Stability Exercises (CSEs) program, in terms of dynamic balance, gait and functional rehabilitation at the end of the intervention (5 weeks) and in the long term (sustained effect over time at 3 and 6 months), in sub-acute post-stroke patients. A secondary objective will be to develop and evaluate the feasibility and efficacy of a specific mobile application (app) to reinforce the adherence to unsupervised home-based CSEs by the own patient in the long term.

Methodology: Multicentre blinded-assessor randomized controlled (parallel group) trial. Study duration per patient will be 29 weeks (intervention period: 5 weeks, followed by 24 weeks follow-up). The study will consist in two parts: 1) A main study (CORE Trial) where physiotherapy modalities will be compared (main comparisons), and 2) an ancillary substudy (CORE-App Study) where the effect of a mobile application (app) will be evaluated (secondary comparison).

Expected results: The study will provide useful information on the short and long term effects of a physiotherapy rehabilitation program based on core stability exercises, as well as the potential use of a mobile app to reinforce long term adherence to unsupervised home-based physiotherapy.

Conditions: Brain Injury, Vascular, Sequelae, Stroke Syndrome, Movement; Disorder, Treatment-Induced, Physical Activity
Being tested: Core stability exercises (CSE), Conventional Physiotherapy
Keywords: stroke, core stability, trunk control, sitting balance, gait, spasticity, falls, activities of daily living, standing balance
Medical subject headings: Cerebrovascular Trauma, Stroke, Motor Activity, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core stability exercises (CSE)Other
Also called trunk control exercises, sitting balance exercises
CSE are exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (physioball). The exercise involves changes in the position of the body without resistance, aiming to improve strength, endurance, proprioception and coordination.
- TENS: Half of the patients assigned to CSE will also receive TENS (highfrequency TENS 100 Hz; 0.2 ms pulse width), administered via TENS stimulator with two disposable 0.9 mm diameter electrodes placed on the skin over the lumbar erector spinae (3 cm lateral to the L3 and L5 spinous process).
Conventional PhysiotherapyOther
Also called Usual Care
The common feature of CP is that it consists of a management by the physiotherapist according to the CP may consist in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc.

Study groups in NCT03975985
Study group	Role	What they receive
Core stability exercises	Experimental	This group will be divided in two: core stability exercises (CSE) plus conventional therapy (CP) and CSE with transcutaneous electrical nerve stimulation (TENS) plus CP. Receives: Other: Core stability exercises (CSE); Other: Conventional Physiotherapy
Conventional physiotherapy (CP)	Active comparator	CP consists in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc. Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Dynamic sitting balance and trunk control
Trunk Impairment Scale Spanish-version TIS 2.0 (S-TIS 2.0), consisting of a dynamic balance subscale (with 10 items) and a coordination subscale (with 6 items). Total score ranges from a minimum of 0 to a maximum of 16. Each item will be performed 3 times and the highest score counts. The tests are verbally explained to the patient and can be demonstrated if needed. The highest possible total score for the S-TIS 2.0 (16 points) indicates a good dynamic sitting balance and correct trunk control and sitting coordination. On the contrary, if the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total scale-score is 0 points.
Measured: Change from Baseline at week 5
Stepping
Brunel Balance Assessment (BBA) (section 3 stepping). Section 3 consists of 6 levels (number 7 to 12) each of which increase the demand on balance ability, ranging from assisted balance to moving within the base of support, and changes of the base of support. At each level, the patient receives a score (1 point) for his/her efforts. Total score ranges from a minimum of 0 to a maximum of 6. This gives an indication on whether the patient is improving within a level, even if he/she is not able to progress to the next level. The score also reflects how well the individual is functioning within this section. Higher values represent a better outcome.
Measured: Change from Baseline at week 5

Secondary outcomes (9)

Sitting balance
Dynamic sitting balance and trunk control will be also measured by the Spanish-version of the Function in Sitting Test (S-FIST). It is a bedside evaluation of sitting balance for the assessment of sensory, motor, proactive, and reactive and steady balance factors. The S-FIST consists of 14 tested parameters, corresponding to functional everyday activities. Each item is scored from 0 to 4, and the total score ranges from 0 to 56, where higher values represent a better outcome.
Measured: Change from Baseline at week 5
Gait speed
Gait measured by BTS G-Walk (accelerometer), a portable system (wireless inertial sensor) for motion analysis. The BTS G-Walk will measure gait speed (meters per second).
Measured: week 5
Standing balance
It will be assessed using the Berg Balance Scale (BBS). It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. 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 balance. Total score ranges from 0 to 56 points, where higher values represent a better outcome.
Measured: Change from Baseline at week 5
Risk of falling
It will be assessed using the Berg Balance Scale (BBS). A score of < 45 points predicts a greater risk of falling. Total score ranges from 0 to 56 points, where higher values represent a better outcome (lowe risk).
Measured: Change from Baseline at week 5
Postural control
It will be assessed using and Spanish version of the Postural Assessment Scale for Stroke (S-PASS). It is a 12 item performance-based scale used for assessing and monitoring postural control following stroke. The scale comprises of 12 items with increasing difficulty which measure balance in lying, sitting and standing. It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes. It consists of a 4 point scale where the items are scored from 0 to 3 and the total scoring ranges from 0 to 36. High score is better postural control.
Measured: Change from Baseline at week 5
Activities of daily living
It will be measured by the modified Barthel Index (BI). It is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. It is a 10-item scale where each activity is given one of five levels of dependency ranging from 0 (unable to perform task) to a maximum of 5, 10, or 15 (fully independent). Each activity is given a score ranging from 0 (unable to perform task) to a maximum of 5, 10, or 15 (fully independent- exact score depends on the activity being evaluated). A total score is obtained by summing points for each of the items. Total scores may range from 0 to 100, with higher scores indicating greater independence.
Measured: Change from Baseline at week 5
Spasticity
It will be measured by Modified Ashworth scale (MAS), which measures resistance during passive soft-tissue stretching of muscle. It is performed while moving the limb at the "speed of gravity", and the corresponding scoring obtained is: 0 - no increase in muscle tone; 1 - slight increase in muscle tone; 1+ - slight increase in muscle tone; 2 - more marked increase in muscle tone through most of the ROM; 3 - considerable increase in muscle tone, passive movement difficult; and 4 - affected part(s) rigid in flexion or extension. A higher score is a worse outcome (more spasticity).
Measured: Change from Baseline at week 5
Rate of falls
It will be measured by a specific registry created specifically for this study. The outcome will be defined as the average number of falls per patient during the intervention period.
Measured: week 5
Health-related quality of life: EQ-5D-5L
It will be evaluated by EQ-5D-5L. It essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201915 Mar 2022

First posted5 Jun 2019
Study start15 Jan 2019
Primary completion15 Mar 2022
Study completion15 Mar 2022

Why it stopped: Due to the COVID-19 pandemic, recruitment was interrupted for several months. In the end, the terms of the grant obtained to conduct the trial did not allow for the extension of the recruitment period beyond one year.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Brain Injury, VascularStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03975985
Sponsor's protocol ID: IIBSP-CSE-2017-56
Acronym: CORE
Status last verified: May 2023
First submitted: 13 Mar 2019
Last updated: 9 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.
PubMed 26451007
Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29.
PubMed 28351168
Cabanas-Valdes R, Girabent-Farres M, Canovas-Verge D, Caballero-Gomez FM, German-Romero A, Bagur-Calafat C. [Spanish translation and validation of the Postural Assessment Scale for Stroke Patients (PASS) to assess balance and postural control in adult post-stroke patients]. Rev Neurol. 2015 Feb 16;60(4):151-8. Spanish.
PubMed 25670044
Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996.
PubMed 24018373
Cabanas-Valdes R, Urrutia G, Bagur-Calafat C, Caballero-Gomez FM, German-Romero A, Girabent-Farres M. Validation of the Spanish version of the Trunk Impairment Scale Version 2.0 (TIS 2.0) to assess dynamic sitting balance and coordination in post-stroke adult patients. Top Stroke Rehabil. 2016 Aug;23(4):225-32. doi: 10.1080/10749357.2016.1151662. Epub 2016 Mar 11.
PubMed 26922850
Cabanas-Valdes R, Bagur-Calafat C, Caballero-Gomez FM, Cervera-Cuenca C, Moya-Valdes R, Rodriguez-Rubio PR, Urrutia G. Validation and reliability of the Spanish version of the Function in Sitting Test (S-FIST) to assess sitting balance in subacute post-stroke adult patients. Top Stroke Rehabil. 2017 Sep;24(6):472-478. doi: 10.1080/10749357.2017.1316548. Epub 2017 Apr 13.
PubMed 28406071
Cabanas-Valdes R, Boix-Sala L, Grau-Pellicer M, Guzman-Bernal JA, Caballero-Gomez FM, Urrutia G. The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 19;18(12):6615. doi: 10.3390/ijerph18126615.
PubMed 34205457
Salgueiro C, Urrutia G, Cabanas-Valdes R. Telerehabilitation for balance rehabilitation in the subacute stage of stroke: A pilot controlled trial. NeuroRehabilitation. 2022;51(1):91-99. doi: 10.3233/NRE-210332.
PubMed 35311721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Additional Core Stability Exercises on Improving Dynamic Sitting Balance, Trunk Control and Functional Rehabilitation for Subacute Stroke Patients: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03975985
Acronym / sponsor ID: CORE / IIBSP-CSE-2017-56
Conditions: Brain Injury, Vascular, Sequelae, Stroke Syndrome, Movement; Disorder, Treatment-Induced, Physical Activity
Keywords: stroke, core stability, trunk control, sitting balance, gait, spasticity, falls, activities of daily living
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the COVID-19 pandemic, recruitment was interrupted for several months. In the end, the terms of the grant obtained to conduct the trial did not allow for the extension of the recruitment period beyond one year.
Enrolment: 87 participants (actual)
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
Collaborators: Universitat Internacional de Catalunya, Parc Taulí Hospital Universitari, Hospital de Terrassa, Hospital de la Santa Creu de Vic, University Ramon Llull, Hospital Sociosanitari Mutuam Girona, Parc de Salut Mar, FIDMAG Germanes Hospitalàries
Study start: 15 Jan 2019 (actual)
Primary completion: 15 Mar 2022 (actual)
Study completion: 15 Mar 2022 (actual)
First posted: 5 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Core stability exercises	Experimental	Other: Core stability exercises (CSE), Other: Conventional PhysiotherapyThis group will be divided in two: core stability exercises (CSE) plus conventional therapy (CP) and CSE with transcutaneous electrical nerve stimulation (TENS) plus CP.
Conventional physiotherapy (CP)	Active comparator	Other: Conventional PhysiotherapyCP consists in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

First ever stroke same and less than 30 days (diagnostic criteria according to the World Health Organization definition; corresponding to ICD-9 code 434) weather cortical or subcortical, and ischemic or haemorrhagic.
Unilateral localization of the stroke verified by computed tomography (CT).
More or equal than18 years.
Ability to understand and execute simple instructions.
Spanish Version of Trunk Impairment Scale.2.0 less than10 points.

Key exclusion criteria (8 listed)

Rankin scale more or equal than 2 points before stroke.
Orthopaedic and other neurological disorders that hamper sitting balance.
Relevant psychiatric disorders that may prevent from following instructions.
Other treatments that could influence the effects of the interventions.
Contraindication to physical activity (e.g., heart failure).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Core stability exercises (CSE)Also: trunk control exercises, sitting balance exercisesCSE are exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (physioball). The exercise involves changes in the position of the body without resistance, aiming to improve strength, endurance, proprioception and coordination. - TENS: Half of the patients assigned to CSE will also receive TENS (highfrequency TENS 100 Hz; 0.2 ms pulse width), administered via TENS stimulator with two disposable 0.9 mm diameter electrodes placed on the skin over the lumbar erector spinae (3 cm lateral to the L3 and L5 spinous process).	Other	Core stability exercises
Conventional PhysiotherapyAlso: Usual CareThe common feature of CP is that it consists of a management by the physiotherapist according to the CP may consist in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc.	Other	Conventional physiotherapy (CP), Core stability exercises

Primary outcome

Dynamic sitting balance and trunk control
Time frame: Change from Baseline at week 5
Trunk Impairment Scale Spanish-version TIS 2.0 (S-TIS 2.0), consisting of a dynamic balance subscale (with 10 items) and a coordination subscale (with 6 items). Total score ranges from a minimum of 0 to a maximum of 16. Each item will be performed 3 times and the highest score counts. The tests are verbally explained to the patient and can be demonstrated if needed. The highest possible total score for the S-TIS 2.0 (16 points) indicates a good dynamic sitting balance and correct trunk control and sitting coordination. On the contrary, if the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total scale-score is 0 points.
Stepping
Time frame: Change from Baseline at week 5
Brunel Balance Assessment (BBA) (section 3 stepping). Section 3 consists of 6 levels (number 7 to 12) each of which increase the demand on balance ability, ranging from assisted balance to moving within the base of support, and changes of the base of support. At each level, the patient receives a score (1 point) for his/her efforts. Total score ranges from a minimum of 0 to a maximum of 6. This gives an indication on whether the patient is improving within a level, even if he/she is not able to progress to the next level. The score also reflects how well the individual is functioning within this section. Higher values represent a better outcome.

9 secondary outcomes

Sitting balance
Time frame: Change from Baseline at week 5
Gait speed
Time frame: week 5
Standing balance
Time frame: Change from Baseline at week 5
Risk of falling
Time frame: Change from Baseline at week 5
Postural control
Time frame: Change from Baseline at week 5
Activities of daily living
Time frame: Change from Baseline at week 5
Spasticity
Time frame: Change from Baseline at week 5
Rate of falls
Time frame: week 5
Health-related quality of life: EQ-5D-5L
Time frame: week 5

Results and safety

The study was stopped early (reason given: Due to the COVID-19 pandemic, recruitment was interrupted for several months. In the end, the terms of the grant obtained to conduct the trial did not allow for the extension of the recruitment period beyond one year.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Background: PubMed 26451007Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.
Background: PubMed 28351168Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29.
Background: PubMed 25670044Cabanas-Valdes R, Girabent-Farres M, Canovas-Verge D, Caballero-Gomez FM, German-Romero A, Bagur-Calafat C. [Spanish translation and validation of the Postural Assessment Scale for Stroke Patients (PASS) to assess balance and postural control in adult post-stroke patients]. Rev Neurol. 2015 Feb 16;60(4):151-8. Spanish.
Background: PubMed 24018373Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996.
Background: PubMed 26922850Cabanas-Valdes R, Urrutia G, Bagur-Calafat C, Caballero-Gomez FM, German-Romero A, Girabent-Farres M. Validation of the Spanish version of the Trunk Impairment Scale Version 2.0 (TIS 2.0) to assess dynamic sitting balance and coordination in post-stroke adult patients. Top Stroke Rehabil. 2016 Aug;23(4):225-32. doi: 10.1080/10749357.2016.1151662. Epub 2016 Mar 11.
Background: PubMed 28406071Cabanas-Valdes R, Bagur-Calafat C, Caballero-Gomez FM, Cervera-Cuenca C, Moya-Valdes R, Rodriguez-Rubio PR, Urrutia G. Validation and reliability of the Spanish version of the Function in Sitting Test (S-FIST) to assess sitting balance in subacute post-stroke adult patients. Top Stroke Rehabil. 2017 Sep;24(6):472-478. doi: 10.1080/10749357.2017.1316548. Epub 2017 Apr 13.
Results publication: PubMed 34205457Cabanas-Valdes R, Boix-Sala L, Grau-Pellicer M, Guzman-Bernal JA, Caballero-Gomez FM, Urrutia G. The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 19;18(12):6615. doi: 10.3390/ijerph18126615.
Results publication: PubMed 35311721Salgueiro C, Urrutia G, Cabanas-Valdes R. Telerehabilitation for balance rehabilitation in the subacute stage of stroke: A pilot controlled trial. NeuroRehabilitation. 2022;51(1):91-99. doi: 10.3233/NRE-210332.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamic sitting balance and trunk control (time frame: Change from Baseline at week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975985, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.