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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Physical Disability; Motor Disorders
• Intervention / Treatment: Device: Rehabilitation treatment using Muvity

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gil Serrancolí, PhD; Phone Number: +34620372629; Email: gil.serrancoli@upc.edu
• Study Contact Backup: Name: Cris Molas, Msc; Email: muvity.rehab@adfo.cat

Study Locations

• Spain
  • Barcelona, Spain, 08019
    • Not yet recruiting
    • Universitat Politècnica de Catalunya
    • Contact: Gil Serrancolí, PhD; Phone Number: +34620372629; Email: gil.serrancoli@upc.edu
    • Principal Investigator: Gil Serrancolí, PhD
    • Sub-Investigator: Jordi Torner, PhD
  • Barcelona
    • Vic, Barcelona, Spain, 08500
      • Recruiting
      • Associació Disminuïts Físics d'Osona
      • Contact: Cris Molas, Msc; Email: muvity.rehab@adfo.cat
      • Contact: Ariadna Pamplona, Msc; Phone Number: +34682885675; Email: projectes@adfo.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Device: Rehabilitation treatment using Muvity; The users have the support of the telerehabilitation system Muvity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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
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

Collaborators and Investigators

• Sponsor: Universitat Politècnica de Catalunya
• Collaborators: Institut Català de la Salut; Consorci Hospitalari de Vic; EAP Vic (CAP Remei); Associació Disminuïts Físics d'Osona
• Investigators: Principal Investigator: Gil Serrancolí, PhD, Universitat Politècnica de Catalunya; Principal Investigator: Cris Molas, Msc, Associació Disminuïts Físics d'Osona

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: telerehabilitation; post-stroke; non-immersive virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Motor Disorders
• Other Study ID Numbers: RehabAtHome_Osona

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We aim to disseminate the aggregated results. The identification of each participant will not be possible for the researchers who will use these data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No