Clinical trial NCT06392802: Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase
Official title: Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Motor Disorders
Physical Disability
Keywords: post-stroke
telerehabilitation
non-immersive virtual reality
Lead sponsor: Universitat Politècnica de Catalunya
Sponsor class: OTHER
Collaborators: name: Consorci Hospitalari de Vic
name: Institut Català de la Salut
name: EAP Vic (CAP Remei)
name: Associació Disminuïts Físics d'Osona
First posted: 2024-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of 25 subjects follow a motor rehabilitation treatment during 12 weeks. One group (Control group) uses the typical rehabilitation process (just doing exercises at home, written on a sheet of paper). The intervention group uses the telerehabilitation system Muvity during 12 weeks at home to perform motor exercises and play exergames.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Engaging in intense physical therapies.
* Severe aphasia: inability or difficulty communicating through speech.
* Cognitive impairments affecting short and mid-term memory.
* Vision: having visual deficits in either eye that may impair screen visualization.
* Vision: experiencing hemispatial neglect, meaning difficulty processing stimuli on the side opposite to the injury.

Primary outcomes:
measure: Fugl-Meyer
timeFrame: Within one week before and within one week after the treatments for both groups.
measure: Berg score
timeFrame: Within one week before and within one week after the treatments for both groups.
measure: Brief Pain Inventory
timeFrame: Within one week before and within one week after the treatments for both groups.
measure: Ranges of motion
timeFrame: Within one week before and within one week after the treatment for both groups and during the 12-week treatment for the intervention group.
Secondary outcomes:
measure: Ranges of motion
timeFrame: During the 12-week treatment for the intervention group.
measure: Time spent for the rehabilitation sessions
timeFrame: During the 12-week treatment for the intervention group.
measure: ECVI-38
timeFrame: Within one week before and within one week after the 12-week treatment
measure: UCLA Self-Rating Depression Scale
timeFrame: Within one week before and within one week after the 12-week treatment
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Associació Disminuïts Físics d'Osona
state: Barcelona
city: Barcelona
country: Spain
facility: Universitat Politècnica de Catalunya
Study officials:
affiliation: Universitat Politècnica de Catalunya
name: Gil Serrancolí, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associació Disminuïts Físics d'Osona
name: Cris Molas, Msc
role: PRINCIPAL_INVESTIGATOR
References: