Biomechanical Analysis of the Effects of Upper Limb Orthosis During the Execution of a Functional Task

November 15, 2016 updated by: Flavia Pessoni Faleiros Macedo Ricci, University of Sao Paulo
The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves functional standard or correction of deformities. There is a lack of studies that analyze the biomechanical changes promoted by the Orthotics in functional pattern of the upper limb. The objective of this proposal is to analyse biomechanical changes in the functional upper limb pattern with the use of orthoses for patients with dysfunctions arising from musculoskeletal system trauma or burns, aiming to contribute with scientific evidence to clinical practice. The project will analyze the changes in the pattern of the upper limb functional through the use of dynamic and static Orthotics by means of kinematic and electromyographic analysis while conducting a functional task. These comparisons will be carried out with and without the use of functional Orthotics, and the controls are the patients themselves. Methods: 25 patients will be included over 18 years with malfunctions resulting from orthopaedic trauma and Burns of the upper limb with indication and Orthotics for improving functional pattern. For characterization of the sample will be performed: esthesiometric , hand and the (Disabilities of the Arm, Shoulder and Hand) DASH Questionnaire. Biomechanical assessment will be used for the analysis and electromyographic kinematics. For statistical analysis will be applied the method of analysis of variance (ANOVA) for repeated measures, and when necessary, the post hoc Bonferroni test. Will be adopted as significance level p ≤ 0.05.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who are using hand orthosis for functional purposes

Exclusion Criteria:

  • neurological problems; cognitive deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: hand orthosis patients
Patients using hand orthosis for better hand function
Device: Hand Orthotic Devices
Orthotic device made to provide the patient with better hand function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyographic assessment
Time Frame: one day
Muscle activity will be measured using surface EMG (TrignoTM Wireless System, Delsys, USA), collected at a sample rate of 2000 Hz.
one day
Kinematic analysis
Time Frame: one day
Movements will be recorded with a ViconTM (Oxford Metrics, UK) motion capture eight-camera system operating at a frequency of 200 Hz.
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional assessment
Time Frame: one day
The DASH questionnaire will be applied and Grip strength will be measured
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PPGRDF-FMRP-USP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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