Early robotic gait training after stroke (ERA Stroke): study protocol for a randomized clinical trial

Area of Science:

• Rehabilitation Medicine
• Neuroscience
• Robotics

Background:

• Walking impairment post-stroke significantly limits functional independence, quality of life, and survival.
• Subacute stroke patients unable to walk may gain the most from robotic gait training (RGT).
• Current rehabilitation practices need further evidence on advanced interventions like RGT.

Purpose of the Study:

• To provide preliminary evidence on the clinical use and efficacy of RGT in subacute stroke recovery.
• To observe the safety, tolerability, feasibility, and cost-effectiveness of RGT during inpatient rehabilitation.
• To establish foundational data for optimizing RGT protocols in stroke rehabilitation.

Main Methods:

• A prospectively registered randomized controlled trial enrolling 54 subacute stroke patients.
• Patients randomized to RGT (90 min/week) or usual care, stratified by stroke severity.
• Comprehensive assessments of walking function, health outcomes, safety, and cost at multiple time points.

Main Results:

• The study is designed to evaluate safety metrics including adverse events and treatment completion rates.
• Walking function will be assessed using gait speed, functional ambulation, and endurance measures.
• Health outcomes will be evaluated using validated scales for neurological impairment, balance, and quality of life.

Conclusions:

• This research aims to establish foundational evidence for the clinical application of RGT in subacute stroke.
• Findings will detail the safety, tolerability, feasibility, and cost-analysis of RGT delivery in inpatient settings.
• The study will inform future, larger trials and clinical guidelines for robotic-assisted stroke rehabilitation.