Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury

NCT03780322 | Completed Phase 4 DMC

• 1 other identifier: ArmeoOBPIConcepcion
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators seek to evaluate the effectiveness of Armeo®Spring Pediatric training, as compared to conventional treatment, in improving upper extremity function in children with Narakas I brachial plexus injury, aged 5-8 years, using the Mallet modified scale and passive range of movement, immediately post intervention and at 3 and 6 months´ follow up. The investigators will also monitor the appearance of adverse effects during and post intervention, with a follow up at 3 and 6 months.

Conditions

Brachial Plexus Neuropathies; Brachial Plexus Birth Palsy

Keywords

brachial plexus birth palsy; Armeo®Spring Pediatric; physical therapy

Outcome Measures

Primary Outcomes (1)

• Change in Modified Mallet Scale

  It measures arm function in 7 different positions: arm at rest, shoulder external rotation, shoulder abduction, hand to neck, hand to mouth, hand to back and supination. Each position can be given a subscore from 1 (very altered) to 5 (almost normal), with a total score of 35. A higher score means better function (closer to normal movement or position). In this case, the investigators will evaluate change in Modified Mallet Scale between baseline (0 weeks), post treatment (5 weeks) and follow up (17 and 29 weeks). It will take into account changes in total scores and subscores in different positions.

  0 weeks, 5 weeks, 17 weeks, 29 weeks

Secondary Outcomes (4)

• Upper extremity passive range of movement

  0 weeks, 5 weeks, 17 weeks and 29 weeks

• Adverse events: pain.

  5 weeks, 17 weeks and 29 weeks

• Adverse events: fatigue

  5 weeks, 17 weeks and 29 weeks

• Adverse events: muscle contracture

  5 weeks, 17 weeks and 29 weeks

Study Arms (2)

Armeo Spring Pediatric

EXPERIMENTAL

This group will receive training with Armeo Spring Pediatric in 45 minute sessions, 3 times a week, for a total of 15 sessions

Device: Armeo Spring Pediatric

Conventional physical and occupational therapy

ACTIVE COMPARATOR

This group will receive combined physical and occupational therapy in 45 minute sessions, 3 times a week, for a total of 15 sessions.

Other: Conventional physical and occupational therapy

Interventions

Armeo Spring Pediatric DEVICE

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.

Armeo Spring Pediatric

Conventional physical and occupational therapy OTHER

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.

Conventional physical and occupational therapy

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages between 5 and 8 years 11 months at beginning of intervention
• Obstetric brachial plexus injury classified as Narakas I
• Legal guardian signs informed consent form

You may not qualify if:

• Evident shoulder or elbow dislocation during physical or radiological examination
• Elbow flexion contracture of 40º or more
• Pain during shoulder or elbow manipulation

Sponsors & Collaborators

• Sociedad Pro Ayuda del Niño Lisiado: lead

Study Sites (1)

Instituto Teleton

Concepción, Región del Biobío, Chile

Location

Related Publications (20)

• 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.

  PMID: 12719390 BACKGROUND

• Varas et al, Eventos Adversos Perinatales: Indicadores epidemiológicos, Revista Obstetricia y Ginecología 2008: 3 (2): 117-122.9

  BACKGROUND

• 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.

  PMID: 19786407 BACKGROUND

• 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.

  PMID: 28650063 BACKGROUND

• 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.

  PMID: 19030261 BACKGROUND

• 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.

  PMID: 28602269 BACKGROUND

• 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.

  PMID: 29199193 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23714792 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25991162 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12098155 BACKGROUND

• 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.

  PMID: 23949025 BACKGROUND

• 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.

  PMID: 16138671 BACKGROUND

• 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.

  PMID: 16891958 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29292028 BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Ines Salas, MD

  Sociedad Pro Ayuda del Niño Lisiado

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 19, 2018
• Study Start: December 18, 2018
• Primary Completion: January 31, 2019
• Study Completion: July 10, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)