NCT04767360

Effects of BIONESS in Rehabilitation of Stroke

Short-term Therapeutic Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Representation in the Rehabilitation of Patients After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.

Detailed description

Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke is generally based on clinical examination. However, according to former studies neurophysiological measures may also have a predictive value. In the acute phase, the combination of the motor score and SEPs are best predictive of outcome. Neurophysiological measures alone are of limited value in predicting long term outcome. However, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables. A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Bioness-300	Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.

Timeline

• Start date: 2021-02-10
• Primary completion: 2021-10-19
• Completion: 2022-12-12
• First posted: 2021-02-23
• Last updated: 2023-03-15

Locations

1 site across 1 country: Germany