NCT01967290

Stroke Wearable Operative Rehabilitation Device Impact Trial

Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Centro Hospitalar de Entre o Douro e Vouga · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. For that purpose the investigators use the SWORD system that combines 3D motion quantification wearable sensors and a vibratory module. The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time. The design of the study is a cross-over randomized clinical trial. With the SWORD system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. The number of correct movements and other motor outcomes will be assessed continuously under both conditions.

Conditions

• Ischemic Stroke
• Upper Extremity Hemiparesis

Interventions

Type	Name	Description
DEVICE	Vibratory feedback and 3D movement analysis	Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
DEVICE	Only 3D movement analysis	Hand-to-mouth task performed under 3D continuous movement analysis only

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2013-10-22
• Last updated: 2013-11-28

Locations

3 sites across 1 country: Portugal