Emergent Therapies in OBP. Pilot Study

Neonatal Brachial Plexus Palsy Clinical Trial

Official title:

Conventional Mirror Therapy and Mirror Therapy Virtual Reality in Obstetric Brachial Palsy: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412603
• Other study ID #: Obstetric Brachial Palsy
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: April 28, 2020

Study information

• Verified date: July 2020
• Source: CEU San Pablo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the affected upper limb within the child's natural environment. The therapeutic interventions of Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the rehabilitation of the affected upper limb and the quality life improvement.

To quantify the increase in the affected upper limb spontaneous use and the quality of life of children with upper OBP from 6-12 years, when They are treated with Conventional MT or Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.

Description:

The intervention protocol was permorfed for four weeks, three days per week applying Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4 weeks. Designed to be done at home.

Two measurements of the affected upper limb spontaneous use and quality of life were performed, a pre-treatment assessment corresponding to the baseline situation, and another post-treatment Assessment to observe the results after the therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 28, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Ages between 6 and 12 years old, upper Obstetric Brachial Palsy type Erb-Duchenne (C5-C6) and extended Erb-Duchenne (C5-C7), preserved functionality to do the activities, adequate cognitive level to follow the proposed activities.

Exclusion Criteria:

• associated pathologies, medical complications or cognitive and / or visual impairment that prevent the activities performance, affected upper limb surgeries in the last year, treatment with botulinum toxin in the last three months, no possession of a device with Android operating system for the application of Virtual Reality therapy, families and children no partners.

Related Conditions & MeSH terms

• Neonatal Brachial Plexus Palsy

Intervention

Other:
• Conventional Mirror Therapy
The Conventional Mirror Therapy was carried out with a mirror box and the Mirror Therapy Virtual Reality was carried out with virtual reality glasses and mobile application: Mirror Therapy VR.

Locations

Country	Name	City	State
Spain	San Pablo-CEU Univerity	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
CEU San Pablo University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Hand-use Experience Questionnaire	To measure the affected upper limb spontaneous use, validated for children with unilateral involvement or disuse of one of their upper limbs from 6 to 18 years in which the experience of children using the affectected upper limb.	Four weeks
Primary	Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0	Modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18.	Four weeks