Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06392802
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase
Sponsor:
Universitat Politècnica de Catalunya
Organization:
Study Overview
Official Title:
Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
As described in the "Catalan Consensus on Evaluation and Treatment of Post-Stroke Patients," in the chronic phase when the effects of stroke have stabilized, patients should continue to have access to rehabilitation services to address their long-term needs. However, the decision to refer patients to rehabilitation services often relies heavily on patient and family demand, lacking clear criteria to ensure coordination between Primary Care services and specialized ones. Considering this gap in action, along with the estimated high costs associated with caring for stroke survivors, non-immersive virtual reality telerehabilitation is proposed as a beneficial tool for both patients and healthcare professionals and managers.
The study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals experiencing post-stroke sequelae.
Objectives (General and Specific)
The general objective of this study is to evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation targeting subjects who have suffered a stroke for more than six months, comparing the effectiveness of conventional therapy with gamified therapy (using the developed computational application).
The specific objectives of the study are as follows:
* Observe changes in joint range of motion (flexion, abduction, horizontal abduction of the shoulder, and elbow flexion) before and after the intervention.
* Assess if game performance (scores, time, etc.) changes between week 2 and week 12.
* Analyze the effects of the computational application on users' balance. Compare balance results between both groups.
* Measure the evolution of the pain variable before and after the intervention and compare it between the two groups.
* Explore potential changes in users' emotional health throughout the intervention.
* Determine the impact of the application on the user's quality of life (QoL).
* Verify if subjects' expectations are met through the application's use.
* Compare treatment adherence using the application versus conventional methodology.
* Determine if using the application leads to greater satisfaction in offering home rehabilitation guidance.
The study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals experiencing post-stroke sequelae.
Objectives (General and Specific)
The general objective of this study is to evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation targeting subjects who have suffered a stroke for more than six months, comparing the effectiveness of conventional therapy with gamified therapy (using the developed computational application).
The specific objectives of the study are as follows:
* Observe changes in joint range of motion (flexion, abduction, horizontal abduction of the shoulder, and elbow flexion) before and after the intervention.
* Assess if game performance (scores, time, etc.) changes between week 2 and week 12.
* Analyze the effects of the computational application on users' balance. Compare balance results between both groups.
* Measure the evolution of the pain variable before and after the intervention and compare it between the two groups.
* Explore potential changes in users' emotional health throughout the intervention.
* Determine the impact of the application on the user's quality of life (QoL).
* Verify if subjects' expectations are met through the application's use.
* Compare treatment adherence using the application versus conventional methodology.
* Determine if using the application leads to greater satisfaction in offering home rehabilitation guidance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: