Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury
NCT ID: NCT03780322
Last Updated: 2023-11-24
Study Results
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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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2018-12-18
2023-07-10
Brief Summary
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Detailed Description
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Armeo Spring Pediatric is a robotic tool that enables upper extremity training using virtual reality. Virtual reality is usually well tolerated and highly motivating to school age children. Since it's a relatively new tool, its effectiveness in the treatment of obstetric brachial plexus injury has not been documented.
This study aims to evaluate the effectiveness of Armeo Spring Pediatric training as compared to conventional therapy (occupational and physical therapy), in improving the upper extremity function of children with Narakas I (C5-C6) obstetric brachial plexus injury.
It will study two parallel groups of children ages 5-8. Both groups will receive 45 minute sessions, 3 times a week, for a total of 5 weeks (15 sessions). One group will train upper extremity function using Armeo Spring Pediatric and the other group will receive occupational and physical therapy, as detailed in protocol. They will be reevaluated at 3 and 6 months.
The appearance of adverse events, such as pain, fatigue or muscle contracture, will be documented during intervention, post intervention, and at 3 and 6 months. In the presence of one such adverse event, the training session will be suspended and the patient evaluated by physiatrist or orthopedic surgeon, with treatment if necessary. If the symptoms resolve before the next session, the patient will complete training as planned. If the symptoms are not resolved by the next session, the patient will be removed from the clinical trial until recovery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Armeo Spring Pediatric
This group will receive training with Armeo Spring Pediatric in 45 minute sessions, 3 times a week, for a total of 15 sessions
Armeo Spring Pediatric
Before intervention, the robotic device will be adjusted to the user's unique dimensions to avoid injury.
Each 45 minute session will include active upper extremity shoulder abduction, shoulder external rotation and/or elbow extension exercises, led by virtual reality game and supported by robotic arm. Sessions will take place 3 times a week for a total of 15 sessions.
Conventional physical and occupational therapy
This group will receive combined physical and occupational therapy in 45 minute sessions, 3 times a week, for a total of 15 sessions.
Conventional physical and occupational therapy
Conventional therapy will combine physical and occupational therapy, including the following activities:
1. Upper extremity weight bearing exercises.
2. Approximation techniques on wrist, elbow and shoulder.
3. Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
4. Scapulothoracic joint mobilization.
5. Stretching of shoulder abductors and external rotators.
6. Hand/wrist facilitation exercises (with ball). This will be carried out in 45 minute sessions, 3 times a week, for a total of 15 sessions.
Interventions
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Armeo Spring Pediatric
Before intervention, the robotic device will be adjusted to the user's unique dimensions to avoid injury.
Each 45 minute session will include active upper extremity shoulder abduction, shoulder external rotation and/or elbow extension exercises, led by virtual reality game and supported by robotic arm. Sessions will take place 3 times a week for a total of 15 sessions.
Conventional physical and occupational therapy
Conventional therapy will combine physical and occupational therapy, including the following activities:
1. Upper extremity weight bearing exercises.
2. Approximation techniques on wrist, elbow and shoulder.
3. Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
4. Scapulothoracic joint mobilization.
5. Stretching of shoulder abductors and external rotators.
6. Hand/wrist facilitation exercises (with ball). This will be carried out in 45 minute sessions, 3 times a week, for a total of 15 sessions.
Eligibility Criteria
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Inclusion Criteria
* Obstetric brachial plexus injury classified as Narakas I
* Legal guardian signs informed consent form
Exclusion Criteria
* Elbow flexion contracture of 40º or more
* Pain during shoulder or elbow manipulation
5 Years
8 Years
ALL
No
Sponsors
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Sociedad Pro Ayuda del Niño Lisiado
OTHER
Responsible Party
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Leslie Stuardo
Principal Investigator
Principal Investigators
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Ines Salas, MD
Role: STUDY_CHAIR
Sociedad Pro Ayuda del Niño Lisiado
Locations
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Instituto Teleton
Concepción, Región del Biobío, Chile
Countries
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References
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Evans-Jones G, Kay SP, Weindling AM, Cranny G, Ward A, Bradshaw A, Hernon C. Congenital brachial palsy: incidence, causes, and outcome in the United Kingdom and Republic of Ireland. Arch Dis Child Fetal Neonatal Ed. 2003 May;88(3):F185-9. doi: 10.1136/fn.88.3.f185.
Varas et al, Eventos Adversos Perinatales: Indicadores epidemiológicos, Revista Obstetricia y Ginecología 2008: 3 (2): 117-122.9
Al-Qattan MM, El-Sayed AA, Al-Zahrani AY, Al-Mutairi SA, Al-Harbi MS, Al-Mutairi AM, Al-Kahtani FS. Narakas classification of obstetric brachial plexus palsy revisited. J Hand Surg Eur Vol. 2009 Dec;34(6):788-91. doi: 10.1177/1753193409348185. Epub 2009 Sep 28.
Vaquero G, Ramos A, Martinez JC, Valero P, Nunez-Enamorado N, Simon-De Las Heras R, Camacho-Salas A. [Obstetric brachial plexus palsy: incidence, monitoring of progress and prognostic factors]. Rev Neurol. 2017 Jul 1;65(1):19-25. Spanish.
Andersen J, Watt J, Olson J, Van Aerde J. Perinatal brachial plexus palsy. Paediatr Child Health. 2006 Feb;11(2):93-100. doi: 10.1093/pch/11.2.93.
Corkum JP, Kuta V, Tang DT, Bezuhly M. Sensory outcomes following brachial plexus birth palsy: A systematic review. J Plast Reconstr Aesthet Surg. 2017 Aug;70(8):987-995. doi: 10.1016/j.bjps.2017.05.007. Epub 2017 May 18.
El-Shamy S, Alsharif R. Effect of virtual reality versus conventional physiotherapy on upper extremity function in children with obstetric brachial plexus injury. J Musculoskelet Neuronal Interact. 2017 Dec 1;17(4):319-326.
Pellegrino G. Eficacia del tratamiento conservador en niños con parálisis braquial obstétrica. Una revisión bibliográfica. [Tesis para optar al grado de fisioterapeuta]. Tenerife España: Universidad de la Laguna; 2018. 46 p.
Arad E, Stephens D, Curtis CG, Clarke HM. Botulinum toxin for the treatment of motor imbalance in obstetrical brachial plexus palsy. Plast Reconstr Surg. 2013 Jun;131(6):1307-1315. doi: 10.1097/PRS.0b013e31828bd487.
Yanes V, Sandobal E, Camero D, Ojeda L. Parálisis braquial obstétrica en el contexto de la rehabilitación física temprana. MediSur. 2014; 12(4): 635-649
Gonzalez JC, Pulido JC, Fernandez F, Suarez-Mejias C. Planning, execution and monitoring of physical rehabilitation therapies with a robotic architecture. Stud Health Technol Inform. 2015;210:339-43.
Sladekova N, Kresanek J. Case report of a patient with cerebral palsy using non-robotic equipment for reeducation movements of paretic upper limb. Prz Med Uniw Rzesz Inst Leków 2014;(1):115-118
Padyšaková H, Repková A, Sládeková N, Žiaková E, Pacek O, Musilová E, Klobucka S. Re-Education Movements of the Paretic Upper Extremity in Children age by Using Non-robotic Equipment. European Journal of Medicine 2015;8(2):106-114
Lum PS, Burgar CG, Shor PC, Majmundar M, Van der Loos M. Robot-assisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Arch Phys Med Rehabil. 2002 Jul;83(7):952-9. doi: 10.1053/apmr.2001.33101.
Ladenheim B, Altenburger P, Cardinal R, Monterroso L, Dierks T, Mast J, Krebs HI. The effect of random or sequential presentation of targets during robot-assisted therapy on children. NeuroRehabilitation. 2013;33(1):25-31. doi: 10.3233/NRE-130924.
You SH, Jang SH, Kim YH, Kwon YH, Barrow I, Hallett M. Cortical reorganization induced by virtual reality therapy in a child with hemiparetic cerebral palsy. Dev Med Child Neurol. 2005 Sep;47(9):628-35.
van der Sluijs JA, van Doorn-Loogman MH, Ritt MJ, Wuisman PI. Interobserver reliability of the Mallet score. J Pediatr Orthop B. 2006 Sep;15(5):324-7. doi: 10.1097/01202412-200609000-00004.
Alba-Martín, R. Fiabilidad y validez de las mediciones en hombro y codo: análisis de una aplicación de Android y un goniómetro. Rehabilitación 2016;50(2): 71-74
Quincho, F. A., Cruz-Castillo, A. A., & Moscoso-Porras, M. G. Fiabilidad y validez de las mediciones en hombro y codo: análisis de una aplicación de Android y un goniómetro. Rehabilitación 2017; 51 (2):137
Cole T, Robinson L, Romero L, O'Brien L. Effectiveness of interventions to improve therapy adherence in people with upper limb conditions: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):175-183.e2. doi: 10.1016/j.jht.2017.11.040. Epub 2017 Dec 29.
Other Identifiers
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ArmeoOBPIConcepcion
Identifier Type: -
Identifier Source: org_study_id