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

Upper Extremity Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02966990
• Other study ID #: PPGRDF-FMRP-USP
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 15, 2016
• Start date: December 2016
• Est. completion date: June 2018

Study information

• Verified date: November 2016
• Source: University of Sao Paulo
• Contact: Flávia Ricci, MSc
• Phone: +55 16 991058971
• Email: flavia.macedo[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients who are using hand orthosis for functional purposes

Exclusion Criteria:

• neurological problems; cognitive deficits

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biomechanical Phenomena
• Electromyography
• Hand
• Musculoskeletal Diseases
• Orthotic Devices
• Upper Extremity Dysfunction

Intervention

Device:
• Hand Orthotic Devices
Orthotic device made to provide the patient with better hand function

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Functional assessment	The DASH questionnaire will be applied and Grip strength will be measured	one day	Yes