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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392802
• Other study ID #: RehabAtHome_Osona
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Universitat Politècnica de Catalunya
• Contact: Gil Serrancolí, PhD
• Phone: +34620372629
• Email: gil.serrancoli[@]upc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Disorders
• Physical Disability
• Stroke

Intervention

Device:
• Rehabilitation treatment using Muvity
The users have the support of the telerehabilitation system Muvity

Locations

Country	Name	City	State
Spain	Universitat Politècnica de Catalunya	Barcelona
Spain	Associació Disminuïts Físics d'Osona	Vic	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Universitat Politècnica de Catalunya	Associació Disminuïts Físics d'Osona, Consorci Hospitalari de Vic, EAP Vic (CAP Remei), Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer	Standard Fugl-Meyer score to assess motor functionality. Sections A (upper limbs, up to 36 points), D (coordination, up to 6 points), H (sensation, up to 6 points), I (joint movement (up to 16 points), and J (joint pain, up to 16 points). The total score could be up to 80 points (the higher score, the higher functionality).	Within one week before and within one week after the treatments for both groups.
Primary	Berg score	The Standard Berg Balance Scale is used to assess balance control. Scores range from 0 (equilibrium heavily affected) to 56 (excellent equilibrium capacity).	Within one week before and within one week after the treatments for both groups.
Primary	Brief Pain Inventory	Standard score to assess joint pain. It consists of 11 questions related to pain intensity. A score of 0 indicates pain absence, and 10 high pain intensity.	Within one week before and within one week after the treatments for both groups.
Primary	Ranges of motion	The ranges of motion of upper and lower limb joint angles are computed before and after the treatments for both control and intervention groups during the assessment face-to-face sessions. This information is also gathered for the intervention group during the 12-week treatment.	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	Ranges of motion	The ranges of motion of upper and lower limb joint angles are computed before and after the treatments for both control and intervention groups during the assessment face-to-face sessions. This information is also gathered for the intervention group during the 12-week treatment	During the 12-week treatment for the intervention group.
Secondary	Time spent for the rehabilitation sessions	The time spent for the rehabilitation sessions is monitored for both groups (by a simple mobile app for the Control group and by Muvity for the intervention group)	During the 12-week treatment for the intervention group.
Secondary	ECVI-38	Quality of life is monitored by the standard test ECVI-38. This stands for "Escala de calidad de vida para el ictus" (ECVI) in Spanish (Quality of Life Scale for Stroke), It ranges between 0 (no impairment) to 100 (maximum impairment).	Within one week before and within one week after the 12-week treatment
Secondary	UCLA Self-Rating Depression Scale	Self-rating depression score. It ranges between 3 (low perception of loneliness) to 9 (high perception of loneliness).	Within one week before and within one week after the 12-week treatment