Emergent Therapies in OBP. Pilot Study

NCT04412603 | Completed

• 1 other identifier: Obstetric Brachial Palsy
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Brachial Plexus Palsy

Keywords

Virtual Reality.; family; Mirror Therapy; Obstetrical Brachial Palsy; Upper extremity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Conventional Mirror Therapy group

EXPERIMENTAL

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

Mirror Therapy Virtual Reality group

EXPERIMENTAL

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

Interventions

Conventional Mirror Therapy 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.

Also known as: Mirror Therapy Virtual Reality

Conventional Mirror Therapy group; Mirror Therapy Virtual Reality group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (1)

San Pablo-CEU Univerity

Madrid, 28668, Spain

Location

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Birth Injuries; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Rocío Palomo, Physiotherapist

  San Pablo-CEU Univerity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: June 2, 2020
• Study Start: February 26, 2020
• Primary Completion: April 5, 2020
• Study Completion: April 28, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)