Back to resultsEmergent Therapies in OBP. Pilot Study
Primary Purpose
Neonatal Brachial Plexus Palsy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional Mirror Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Brachial Plexus Palsy focused on measuring Virtual Reality., family, Mirror Therapy, Obstetrical Brachial Palsy, Upper extremity
Eligibility Criteria
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.
Sites / Locations
- San Pablo-CEU Univerity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional Mirror Therapy group
Mirror Therapy Virtual Reality group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04412603
First Posted
February 19, 2020
Last Updated
July 31, 2020
Sponsor
CEU San Pablo University
1. Study Identification
Unique Protocol Identification Number
NCT04412603
Brief Title
Emergent Therapies in OBP. Pilot Study
Official Title
Conventional Mirror Therapy and Mirror Therapy Virtual Reality in Obstetric Brachial Palsy: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEU San Pablo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Brachial Plexus Palsy
Keywords
Virtual Reality., family, Mirror Therapy, Obstetrical Brachial Palsy, Upper extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Mirror Therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Mirror Therapy Virtual Reality group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Mirror Therapy
Other Intervention Name(s)
Mirror Therapy Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Children's Hand-use Experience Questionnaire
Description
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.
Time Frame
Four weeks
Title
Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0
Description
Modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18.
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocío Palomo, Physiotherapist
Organizational Affiliation
San Pablo-CEU Univerity
Official's Role
Study Director
Facility Information:
Facility Name
San Pablo-CEU Univerity
City
Madrid
ZIP/Postal Code
28668
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Emergent Therapies in OBP. Pilot Study
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