Emergent Therapies in OBP. Pilot Study

Sponsor

CEU San Pablo University (Other)

Overall Status

Completed

CT.gov ID

NCT04412603

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Brachial Plexus Palsy	Other: Conventional Mirror Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 26, 2020

Actual Primary Completion Date :

Apr 5, 2020

Actual Study Completion Date :

Apr 28, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.