Protocol for a single-blind randomized controlled clinical trial to investigate the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke.

BACKGROUND

The dosage and intensity of physical therapy are crucial factors influencing the motor recovery of the hemiplegic lower limb in patients with subacute stroke. Biofeedback using wearable sensors may provide opportunities for patients with stroke to effectively guide self-exercises with monitoring of muscular activities in hemiplegic lower limbs. This study aims to explore the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke.

METHODS

This is a pilot randomized controlled trial comparing conventional physical therapy with additional in-bed self-exercises based on electromyography sensor feedback and conventional physical therapy alone. The interventions will be adjusted according to the muscle strength and Brunnstrom recovery stage in the hemiplegic lower limbs. The primary outcome measure is the Pittsburgh Rehabilitation Participation Scale. The secondary outcome measures include the number and percentage of participating sessions, number and percentage of effortful sessions, number and percentage of successful sessions, mean amplitude of muscle contractions in a session, duration and percentage of participating sessions during self-exercises, Rivermead Motor Assessment, Manual Muscle Test, Brunnstrom recovery stage, Fugl-Meyer assessment, Berg Balance Scale, Functional Ambulation Category, modified Rankin scale, and Short-Form Health Survey 36 version 2.

RESULTS

The results will be described in future studies.

CONCLUSION

This clinical trial will estimate the feasibility and safety of in-bed self-exercises based on electromyography sensor feedback in patients with subacute stroke. If the expected results are achieved in this study, stroke rehabilitation methods will be enriched.

TRIAL REGISTRATION: clinicialtrials.gov, NCT05820815.