Physical Activity Clinical Trial
— COREOfficial 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
Verified date | May 2023 |
Source | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 87 |
Est. completion date | March 15, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | FIDMAG Germanes Hospitalàries, Hospital de la Santa Creu de Vic, Hospital de Terrassa, Hospital Parc Taulí, Sabadell, Hospital Sociosanitari Mutuam Girona, Parc de Salut Mar, Universitat Internacional de Catalunya, University Ramon Llull |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from Baseline at week 5 | |
Primary | 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. | Change from Baseline at week 5 | |
Secondary | 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. | Change from Baseline at week 5 | |
Secondary | 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). | week 5 | |
Secondary | 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. | Change from Baseline at week 5 | |
Secondary | 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). | Change from Baseline at week 5 | |
Secondary | 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. | Change from Baseline at week 5 | |
Secondary | 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. | Change from Baseline at week 5 | |
Secondary | 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). | Change from Baseline at week 5 | |
Secondary | 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. | week 5 | |
Secondary | 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'. | week 5 |
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