Stroke Wearable Operative Rehabilitation Device Impact Trial

NCT01967290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-11-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centro Hospitalar de Entre o Douro e Vouga

    lead OTHER

Principal Investigators

  • Vítor T. Cruz, MD · Centro Hospitalar de Entre o Douro e Vouga

  • Paula Coutinho, PhD · IBMC - University of Oporto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967290 on ClinicalTrials.gov