Home-Based Virtual Reality Rehabilitation after Stroke: A Multicenter Randomized Controlled Trial of RGS@home

Technical Summary: Home-Based Virtual Reality Rehabilitation after Stroke (RGS@home)

Problem Statement

Stroke survivors frequently face a critical gap in rehabilitation access once they transition from clinical settings to the home environment. Traditional post-discharge therapy is often reduced, unsupervised, and hindered by logistical and motivational barriers. While digital health solutions like virtual reality (VR) and telerehabilitation have shown promise, existing literature is limited by single-site designs, short-term follow-ups, lack of objective adherence metrics, and insufficient validation in real-world, uncontrolled environments. There is a specific need for rigorous, multicenter randomized controlled trials (RCTs) that evaluate the clinical effectiveness, feasibility, and long-term sustainability of autonomous home-based rehabilitation systems, particularly regarding their ability to maintain engagement and reduce symptom burdens like fatigue in chronic populations.

Methodology

Study Design:
The RGS@home study was a multicenter, randomized controlled trial conducted across three European countries (Spain, France, and Sweden). Participants were randomized in a 2:1 ratio to either the intervention group (RGS@home plus standard care) or the control group (standard care alone). The larger intervention arm was designed to facilitate a robust assessment of feasibility, usability, and adherence.

Participants:
The study recruited stroke survivors in subacute and chronic phases (age 20–85) with mild-to-moderate upper-limb motor impairments (MRC scale ≥2) and no severe cognitive deficits (MoCA ≥19). Recruitment was impacted by the COVID-19 pandemic, resulting in a final analytic cohort of 40 participants (RGS N=30; Control N=10) after excluding one influential observation based on pre-specified diagnostics.

Intervention:
The intervention group utilized the Rehabilitation Gaming System (RGS@home), a VR-based platform grounded in motor learning and neuroplasticity principles.

• Delivery: Daily, gamified VR exercises delivered via a personal computer application.
• Protocol: Sessions lasted ~25 minutes, comprising 4–9 tasks targeting upper-limb motor and cognitive function. Difficulty was automatically adapted to maintain a ~70% success rate.
• Adherence: Participants were provided with the RGSwear, a wearable device to monitor adherence and encourage paretic limb use (though kinematic data from this device was not included in the final analysis due to inconsistent use).

Control:
The control group received standard rehabilitation care according to local clinical practices, including guidance for continued rehabilitation, without RGS-based training.

Outcomes and Analysis:

• Primary Outcome: Functional independence measured by the Barthel Index (BI) at 12 months.
• Secondary Outcomes: Upper-limb motor function (Fugl-Meyer Assessment, FM-UE), activity capacity (CAHAI), grip force, fatigue (Fatigue Severity Scale, FSS), quality of life (SS-QoL, SF-36), mood (HDRS-17), and pain (VAS).
• Feasibility Metrics: Usability (System Usability Scale, SUS), adherence (logged training hours), and healthcare resource utilization (therapist time, travel burden, costs).
• Statistical Approach: Linear mixed-effects models (REML) were used for longitudinal analysis with Group, Time, and their interaction as fixed effects. Non-parametric tests (Mann-Whitney U) were used for skewed resource use data.

Key Results

Primary Outcome (Functional Independence):
No statistically significant between-group difference was observed for the primary outcome (BI) at 12 months (p = 0.476). However, the authors note that interpretation was severely limited by substantial ceiling effects, particularly in the RGS group where 50% of participants had baseline BI scores ≥95.

• Longitudinal Trajectory: Despite the ceiling effect, exploratory analysis of the 3-to-12-month trajectory revealed a significant Group × Time interaction (β = +4.68, p = 0.004). The RGS group maintained or slightly improved functional independence (+1.51 points), whereas the Control group declined (-3.00 points).
• Recovery Efficiency: The RGS group demonstrated significantly higher "Normalized Potential Gain" (capturing 29.0% of remaining functional potential) compared to controls (p = 0.016).

Secondary Outcomes:

• Fatigue: A significant between-group difference emerged at 12 months. The RGS group showed a reduction in fatigue scores, while the Control group experienced an increase. The adjusted difference was -11.86 points (95% CI -22.09 to -1.64; p = 0.023).
• Motor Function: Within-group improvements in FM-UE, CAHAI, and grip force were observed in the RGS group over time (significant at 12 months). Between-group differences did not reach statistical significance, likely due to sample size constraints and the high baseline function of the RGS group.
• Usability: The system demonstrated exceptionally high usability, with mean System Usability Scale (SUS) scores of 86.0 at 3 months and 82.3 at 12 months (Grade A), indicating high accessibility for unsupervised home use.
• Resource Use: The RGS intervention significantly reduced therapist contact time (median 2.5 vs. 27.0 hours; p = 0.044) and travel burden (median 0.0 vs. 3.9 hours; p = 0.045) compared to standard care.

Adherence and Predictors:
Training dose varied widely (27% to 296% of prescribed dose). Baseline fatigue was identified as a significant negative predictor of training dose (β = -0.66, p = 0.030), suggesting that higher fatigue levels hindered self-directed engagement.

Significance and Claims

The paper claims that while the primary outcome measure (BI) failed to detect a significant between-group difference—largely due to measurement insensitivity in a high-functioning population—the RGS@home intervention was feasible, safe, and usable in a real-world, unsupervised home setting.

The study's significance lies in demonstrating that home-based VR rehabilitation can:

1. Sustain Engagement: Maintain high usability and adherence over a 12-month period without direct therapist supervision.
2. Mitigate Symptom Burden: Significantly reduce post-stroke fatigue, a debilitating symptom often exacerbated by inactivity, suggesting that low-intensity, self-directed activity can interrupt the cycle of deconditioning.
3. Optimize Resources: Substantially reduce the demand on therapist time and patient travel, offering a scalable model for long-term care.
4. Support Long-Term Recovery: Provide evidence that functional recovery trajectories can be sustained or improved in the chronic phase, even when standard functional scales reach their ceiling.

The authors conclude that RGS@home represents a viable complementary approach to standard care, particularly for the chronic phase of stroke recovery, aligning with European priorities for scalable, community-based rehabilitation strategies. They emphasize that future trials should prioritize outcome measures sensitive to domain-specific activity and participation rather than general independence scales that may suffer from ceiling effects in this demographic.