Stroke Wearable Operative Rehabilitation Device Impact Trial "SWORD-IT"

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • Vibratory feedback and 3D movement analysis Device
    Other Names: Propriocetive actuation; Vibratory stimulation; SWORD; Stroke Wearable Operative Rehabilitation Device
    Intervention Desc: Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
    ARM 1: Kind: Experimental
    Label: Hand-to-mouth task - vibratory feedback
    Description: Hand-to-mouth task under vibratory feedback and 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis and provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed a vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status.
  • Only 3D movement analysis Device
    Other Names: 3D movement quantification; 3D movement characterization; SWORD; Stroke Wearable Operative Rehabilitation Device
    Intervention Desc: Hand-to-mouth task performed under 3D continuous movement analysis only
    ARM 1: Kind: Experimental
    Label: Hand-to-mouth task - no vibratory feedback
    Description: Hand-to-mouth task in the same conditions as the experimental arm but without vibratory feedback, only 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis but does not provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed NO vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of correct movements At the end of each hand-to-mouth task. No
Secondary Total number of movements At the end of each hand-to-mouth task. No
Secondary Range of motion in degrees At the end of each hand-to-mouth task. No
Secondary Time between correct movements in seconds At the end of each hand-to-mouth task. No
Secondary Cumulative amplitude of correct movements in degrees At the end of each hand-to-mouth task No
Secondary Cumulative amplitude of all movements performed in degrees At the end of each hand-to-mouth task. No
Secondary Number of pause events during the task At the end of each hand-to-mouth task No
Secondary Fatigue At the end of each hand-to-mouth task. Yes
Secondary Pain At the end of each hand-to-mouth task. Yes
Secondary Number and type of other distresses At the end of each hand-to-mouth task. Yes

Sponsors