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

NCT02966990 | Unknown

• 1 other identifier: PPGRDF-FMRP-USP
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Orthotic Devices; Electromyography; Biomechanical Phenomena; Hand; Upper Extremity Dysfunction

Outcome Measures

Primary Outcomes (2)

• Electromyographic assessment

  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

  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 Outcomes (1)

• Functional assessment

  one day

Study Arms (1)

hand orthosis patients

OTHER

Patients using hand orthosis for better hand function

Device: Hand Orthotic Devices

Interventions

Hand Orthotic Devices DEVICE

Orthotic device made to provide the patient with better hand function

hand orthosis patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who are using hand orthosis for functional purposes

You may not qualify if:

• neurological problems; cognitive deficits

Sponsors & Collaborators

• University of Sao Paulo: lead

Central Study Contacts

Flávia Ricci, MSc

CONTACT

+55 16 991058971; flavia.macedo@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 17, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: November 17, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share