Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Stroke is the second leading cause of death worldwide and the primary medical cause of disability. It is estimated that 45% of affected individuals will continue to have moderate or severe functional disabilities throughout their lives. According to the American Stroke Association, telerehabilitation has the potential to provide timely and efficient care to stroke survivors, improving patients' functional outcomes while reducing long-term disability and associated costs. Hypothesis: Through the developed application (Muvity), the study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals in the post-stroke sequelae phase.

Objectives: To evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation for patients who have experienced a stroke more than 6 months ago. Methodology: Prospective longitudinal study with single blinding. The control group undergoes a conventional intervention, while the experimental group undergoes an innovative intervention (n=25). Variables: The collected variables and measurement tools include upper extremity functionality (Fugl-Meyer scale), balance (Berg), functional independence (Barthel), pain (Brief Pain Inventory), post-stroke quality of life (ECVI-38), emotional health (UCLA Self-Rating Depression Scale), treatment expectations (Expectation for Treatment Scale), treatment adherence (through an APP), and satisfaction (Telehealth Usability Questionnaire). Statistical Analysis: Data will be analyzed per protocol (PP); the normality distribution of the data will be assessed, and results will be analyzed using parametric or non-parametric techniques depending on normality. A bivariate analysis will compare results between the control and intervention groups, considering a statistically significant result when p \< 0.05. Expected

Results: Similar results are expected between groups or slightly favorable outcomes in the experimental group for the different variables. Applicability and Relevance: The application would facilitate access to motor rehabilitation treatments in an enjoyable and engaging manner, promoting physical activity and contributing to a healthy lifestyle. Upon obtaining the results of this study, a trial implementation of the application in five socio-sanitary or associative centers is planned to verify its final applicability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age: between 18 and 85 years old.

• Stroke duration of more than six months + Discharge from post-stroke rehabilitation.

• Moderate physical disability: scoring between 1-3 on the Modified Rankin Scale.

• Standing: able to stand safely for 2 minutes without support (maximum score -4- on item 2 of the Berg Scale).

• Vision: capable of correctly visualizing a screen at a distance of 2 meters.

• Cognitive status: No cognitive impairment or mild cognitive impairment (Mini-Mental State Examination score ≥ 24). Ability to understand and follow verbal instructions in Catalan or Spanish.

• Technological skills: capable of basic use of a mobile phone and computer (keyboard, mouse, screen).

• Glenohumeral joint mobility: minimum of 30º flexion, abduction, horizontal abduction; and 15º internal and external rotation.

• Elbow joint mobility: minimum of 45º flexion.

Locations
Other Locations
Spain
Universitat Politècnica de Catalunya
NOT_YET_RECRUITING
Barcelona
Associació Disminuïts Físics d'Osona
RECRUITING
Vic
Contact Information
Primary
Gil Serrancolí, PhD
gil.serrancoli@upc.edu
+34620372629
Backup
Cris Molas, Msc
muvity.rehab@adfo.cat
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-03
Participants
Target number of participants: 50
Treatments
No_intervention: Control
This group follows a treatment similar to the one that a public hospital recommends. They receive a sheet of paper with the description of some exercises to do at home. These should be done in three 30-min-sessions per week, during 12 weeks.
Experimental: Muvity - Intervention
This group follows a treatment prescribed by a therapist using Muvity, a telerehabilitation system using a depth camera. The treatment consists of some exercises guided by a virtual avatar, and some exergames to play. The computer application monitors the ranges of motion of joint angles as well as time played and deviations from theoretical trajectories. These sessions are programmed to be done in three 30-min-sessions per week, during 12 weeks (same amount as the Control group).
Related Therapeutic Areas
Sponsors
Collaborators: Consorci Hospitalari de Vic, Institut Català de la Salut, EAP Vic (CAP Remei), Associació Disminuïts Físics d'Osona
Leads: Universitat Politècnica de Catalunya

This content was sourced from clinicaltrials.gov