Emergent Therapies in OBP. Pilot Study

Not Applicable

Completed

• Conditions: Neonatal Brachial Plexus Palsy

• Registration Number: NCT04412603
• Lead Sponsor: CEU San Pablo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study Start: 2020-02-26
• Primary Completion: 2020-04-05
• Study Completion: 2020-04-28
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0	Four weeks	Modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18.
Children's Hand-use Experience Questionnaire	Four weeks	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.

Trial Locations

Locations (1)

San Pablo-CEU Univerity; 🇪🇸 Madrid, Spain