Emergent Therapies in OBP. Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Brachial Plexus Palsy
• Intervention / Treatment: Other: Conventional Mirror Therapy

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28668
    • San Pablo-CEU Univerity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Mirror Therapy group; 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; 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.; Other Names: Mirror Therapy Virtual Reality
Experimental: Mirror Therapy Virtual Reality group; 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; 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.; Other Names: Mirror Therapy Virtual Reality

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CEU San Pablo University
• Investigators: Study Director: Rocío Palomo, Physiotherapist, San Pablo-CEU Univerity

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): April 5, 2020
• Study Completion (Actual): April 28, 2020

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: family; Upper extremity; Mirror Therapy; Virtual Reality.; Obstetrical Brachial Palsy
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Birth Injuries; Brachial Plexus Neuropathies; Neonatal Brachial Plexus Palsy
• Other Study ID Numbers: Obstetric Brachial Palsy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No