Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392802
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-01-17
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:
Universitat Politècnica de Catalunya
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 n25
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 005
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 n25
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 005
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 users quality of life QoL
Verify if subjects expectations are met through the applications 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 users quality of life QoL
Verify if subjects expectations are met through the applications 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:
None
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?:
None