Effectiveness of Physiotherapy After Stroke

NCT06165666 | Active Not Recruiting

• 1 other identifier: Stroke Project
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization (WHO) defines Stroke or Cerebrovascular Accident as clinical sign of focal disorder in brain functioning of rapid onset, with a presumed vascular origin and duration of more than 24 hours. It represents the first cause of physical disability in adults, and approximately half of people who survive stroke present motor and sensitivity disorders, which cause alterations in functionality, especially in activities of daily living, with the consequent impact negative in participation in the environment and the quality of life of people and their families. The objective of the study is to know the effectiveness of a Physiotherapy intervention, based on the achievement of objectives, in improving functionality, participation and quality of life after a Stroke compared to treatment protocol. Methodology: single-blind randomized controlled clinical trial. The sample of 62 subjects (31 in each group) will be recruited at the Ramon y Cajal University Hospital. The Physiotherapy intervention will consist of 30 sessions, 3 times/week, for 10 consecutive weeks, in which the treatment for the Experimental Group will be based on training of specific tasks aimed at functional objectives previously agreed upon with the person/user vs. the Control Group who will receive a conventional Physiotherapy treatment protocol. The outcome variables are: perception of quality of life (Spanish version of The Newcastle Stroke-specific Quality of Life Measure); degree of functional disability (Barthel Index); level of gait functionality (Spanish version of Functional Ambulation Categories); dynamic balance and trunk control (Spanish version of Trunk Impairment Scale); postural control (Spanish version of the Postural Assessment Scale for Stroke Patients); and participation in the environment (Spanish version of the Oxford Participation and Activities Questionnaire). They will be collected at three times: before starting the study, initial assessment (V0), at the end of the intervention for each group, intermediate assessment (V1) and 6 months after V0 (V2).

Conditions

Stroke

Keywords

stroke; physiotherapy; clinical trial

Outcome Measures

Primary Outcomes (3)

• Perception of quality of life

  Spanish version of NewsQoL

  Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.

• Functional disability

  Barthel index

  Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.

• Participation in the environment

  Spanish version Oxford Participation and Activities Questionnaire

  Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.

Secondary Outcomes (3)

• Level of gait functionality

  Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.

• Dynamic balance and trunk control

  Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.

• Postural control

  Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.

Other Outcomes (1)

• Cognitive impairment

  Prior to inclusion in the study

Study Arms (2)

intervention group (EG)

EXPERIMENTAL

The participants will receive as a therapeutic approach 3 physical therapy sessions/week of 40' duration, for 10 weeks.

Other: Approach by functional objectives

control group (CG)

ACTIVE COMPARATOR

The participants will receive as a therapeutic approach 3 physical therapy sessions/week of 40' duration, for 10 weeks.

Other: Treatment protocol

Interventions

Approach by functional objectives OTHER

The therapeutic approach that will be administered to the EG will be based on the training of specific tasks aimed at functional objectives. Each session will begin with activities to activate the muscles of the trunk, pelvis and lower limbs, to modify atypical movement patterns and prepare the muscles for a more effective contraction. Subsequently, activity training will be carried out in a functional and meaningful context, aimed at specific and significant functional objectives for the participant and previously agreed upon with them.

intervention group (EG)

Treatment protocol OTHER

The therapeutic approach of the participants assigned to the CG will be aimed at maintaining joint ranges and transfer work, passive mobilization of the paretic lower and upper limb, maintenance of sitting posture with/without assistance, transfer from sitting to standing, from standing to sitting. and coordination work. Subsequently, initiation of walking with a support product and/or help, if possible.

control group (CG)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with stroke between 6 and 24 months before the intervention.
• Age 50 or more years.
• Have signed the informed consent.

You may not qualify if:

• Present moderate or severe cognitive impairment according to the Pfeiffer Questionnaire.
• Have other serious diseases with a significant impact on functional capacity.
• Suffer previously diagnosed psychiatric pathology.
• Being dependent for activities of daily living before suffering the stroke.

Sponsors & Collaborators

• University of Alcala: lead
• Hospital Universitario Ramon y Cajal: collaborator

Study Sites (1)

Concepción Soto-Vidal

Alcalá de Henares, Madrid, 28871, Spain

Location

Related Publications (10)

• Murie-Fernandez M, Irimia P, Martinez-Vila E, John Meyer M, Teasell R. [Neuro-rehabilitation after stroke]. Neurologia. 2010 Apr;25(3):189-96. Spanish.

  PMID: 20492866 BACKGROUND

• Wonsetler EC, Bowden MG. A systematic review of mechanisms of gait speed change post-stroke. Part 2: exercise capacity, muscle activation, kinetics, and kinematics. Top Stroke Rehabil. 2017 Jul;24(5):394-403. doi: 10.1080/10749357.2017.1282413. Epub 2017 Feb 20.

  PMID: 28218021 BACKGROUND

• Tan YK, Goh C, Leow AST, Tambyah PA, Ang A, Yap ES, Tu TM, Sharma VK, Yeo LLL, Chan BPL, Tan BYQ. COVID-19 and ischemic stroke: a systematic review and meta-summary of the literature. J Thromb Thrombolysis. 2020 Oct;50(3):587-595. doi: 10.1007/s11239-020-02228-y.

  PMID: 32661757 BACKGROUND

• Alessandro L, Olmos LE, Bonamico L, Muzio DM, Ahumada MH, Russo MJ, Allegri RF, Gianella MG, Campora H, Delorme R, Vescovo ME, Lado V, Mastroberti LR, Butus A, Galluzzi HD, Decima G, Ameriso SF. [Multidisciplinary rehabilitation for adult patients with stroke]. Medicina (B Aires). 2020;80(1):54-68. Spanish.

  PMID: 32044742 BACKGROUND

• Kwakkel G, Stinear C, Essers B, Munoz-Novoa M, Branscheidt M, Cabanas-Valdes R, Lakicevic S, Lampropoulou S, Luft AR, Marque P, Moore SA, Solomon JM, Swinnen E, Turolla A, Alt Murphy M, Verheyden G. Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. Eur Stroke J. 2023 Dec;8(4):880-894. doi: 10.1177/23969873231191304. Epub 2023 Aug 7.

  PMID: 37548025 BACKGROUND

• Leonardi M, Fheodoroff K. Goal Setting with ICF (International Classification of Functioning, Disability and Health) and Multidisciplinary Team Approach in Stroke Rehabilitation. 2021 Jan 15. In: Platz T, editor. Clinical Pathways in Stroke Rehabilitation: Evidence-based Clinical Practice Recommendations [Internet]. Cham (CH): Springer; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK585584/

  PMID: 36315695 BACKGROUND

• Rosewilliam S, Roskell CA, Pandyan AD. A systematic review and synthesis of the quantitative and qualitative evidence behind patient-centred goal setting in stroke rehabilitation. Clin Rehabil. 2011 Jun;25(6):501-14. doi: 10.1177/0269215510394467. Epub 2011 Mar 25.

  PMID: 21441308 BACKGROUND

• Sugavanam T, Mead G, Bulley C, Donaghy M, van Wijck F. The effects and experiences of goal setting in stroke rehabilitation - a systematic review. Disabil Rehabil. 2013 Feb;35(3):177-90. doi: 10.3109/09638288.2012.690501. Epub 2012 Jun 7.

  PMID: 22671934 BACKGROUND

• Azevedo da Costa F, Araujo da Silva DL, da Rocha VM. [The functional condition of patients following a cerebrovascular accident]. Rev Neurol. 2006 May 16-31;42(10):591-5. Spanish.

  PMID: 16703526 RESULT

• Soto-Vidal C, Calvo-Fuente V, Hidalgo-Galante E, Cerezo-Tellez E, Perez-Martin Y, Pacheco-da-Costa S. Effectiveness of Physiotherapy for Improving Functionality, Participation, and Quality of Life after a Stroke: Study Protocol for a Randomized Controlled Clinical Trial. J Pers Med. 2024 Aug 22;14(8):891. doi: 10.3390/jpm14080891.

  PMID: 39202082 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Concepción Soto-Vidal

  University of Alcala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind, parallel, randomized controlled clinical trial, allocation ratio 1:1 and with third-party evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Degree Teacher in Physiotherapy

Model Details: Participants are randomly assigned into 2 groups (intervention group (EG) and control group (CG)).

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: February 12, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)