Emergent Therapies in OBP. Pilot Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Brachial Plexus Palsy

Intervention / Treatment
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* Other: Conventional Mirror Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Mirror Therapy group<br>Therapy: -With the affected upper limb into the mirror box, perform the exercise with the non-affected extremity which is reflected in the mirror box. -The affected side must perform the corresponding movement within its possibilities, according to the exercise that is being performed with the healthy arm. - It is very important to look at the mirror at all times, which reflects the non-affected side while doing the exercises. | Other: Conventional Mirror Therapy<br>* 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.<br>* Other names: Mirror Therapy Virtual Reality;|
| Experimental: Mirror Therapy Virtual Reality group<br>Therapy: -Perform the exercises with the non-affected limb, which must be watched constantly with virtual reality glasses, to interpret that this limb corresponds to the affected side. - The affected side accompanies the movement within its possibilities (out of sight of the patient, it can be covered with a handkerchief). - It is very important to look at the non-affected side. The affected side should be out of the visual field to avoid confusion. | Other: Conventional Mirror Therapy<br>* 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.<br>* Other names: Mirror Therapy Virtual Reality;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality., family, Mirror Therapy, Obstetrical Brachial Palsy, Upper extremity