Emergent Therapies in OBP. Pilot Study

NCT ID: NCT04412603

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2020-04-28

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.

Conditions

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Neonatal Brachial Plexus Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Conventional Mirror Therapy

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Conventional Mirror Therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Mirror Therapy Virtual Reality

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CEU San Pablo University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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RocĂ­o Palomo, Physiotherapist

Role: STUDY_DIRECTOR

San Pablo-CEU Univerity

Locations

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San Pablo-CEU Univerity

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Obstetric Brachial Palsy

Identifier Type: -

Identifier Source: org_study_id

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