Brachial Plexus NeuropathiesPhase 4NCT03780322
Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury
A Phase 4 study testing Armeo Spring Pediatric and Conventional physical and occupational therapy in people with Brachial Plexus Neuropathies and Brachial Plexus Birth Palsy, run by Sociedad Pro Ayuda del Niño Lisiado at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Brachial Plexus Neuropathies, Brachial Plexus Birth Palsy
- What is being tested?
- Armeo Spring Pediatric and Conventional physical and occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChile
- Study dates
- 18 Dec 2018to 10 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Evident shoulder or elbow dislocation during physical or radiological examination
- Elbow flexion contracture of 40º or more
- Pain during shoulder or elbow manipulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Armeo Spring Pediatric in Children With Narakas I Obstetric Brachial Plexus Injury
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.
Read the detailed description
Obstetric brachial plexus injury is caused by damage of the cervical nerve roots C5-T1 during delivery. It has traditionally been treated with occupational and physical therapy during the first few months, evaluating at 1, 3 and 6 months if primary surgery is required. The goal of primary surgery is to repair the damaged nerve roots and restore neural function. Despite surgery, a large percentage of children will remain with varying degrees of paralysis. Since Narakas I ("Erb's") paralysis is the most common, motor sequelae usually involve limited shoulder abduction, restricted shoulder external rotation and elbow flexion contracture. This sequelae requires ongoing physical and occupational therapy, especially during school age, to ensure adequate upper extremity function and participation.
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.
- Being tested
- Armeo Spring Pediatric, Conventional physical and occupational therapy
- Keywords
- brachial plexus birth palsy, Armeo®Spring Pediatric, physical therapy
- Medical subject headings
- Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo Spring PediatricDevice
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 therapyOther
Conventional therapy will combine physical and occupational therapy, including the following activities:
- Upper extremity weight bearing exercises.
- Approximation techniques on wrist, elbow and shoulder.
- Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
- Scapulothoracic joint mobilization.
- Stretching of shoulder abductors and external rotators.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Conventional physical and occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 weeks, 5 weeks, 17 weeks, 29 weeks
Secondary outcomes (4)
Upper extremity passive range of movement
Will be measured by goniometry
Measured: 0 weeks, 5 weeks, 17 weeks and 29 weeks
Adverse events: pain.
Will be measured by Visual Analogue Scale. The visual analogue scale is a unidimensional measure of pain intensity. The patient marks on the line the point that they feel represents their perception of their current state. The investigator will then measure in millimeters the distance from left to right (0-100 mm) to quantify the amount of pain. A low score means less intense pain and a high score means more severe pain.
The Visual Analogue Scale uses many formats (straight line, boxes, happy/sad faces). Because of the age of the study population in this clinical trial, the investigators have decided to use the happy/sad faces scale.
At 5, 17 and 29 weeks, the patient will be asked to document the pain they feel at that moment, not during the treatment.
Measured: 5 weeks, 17 weeks and 29 weeks
Adverse events: fatigue
Will be measured by Borg Scale The Borg Scale is an instrument that quantifies the exertion perceived by the patient with a score from 0-10, as follows: 0 = at rest; 1 = very easy, 2 = somewhat easy, 3 = moderate; 4 = somewhat hard, 5-6 = hard; 7-8 = really, really hard; 8-9 = really, really, really hard; 10 = maximal effort.
At 5 weeks, the patient will be asked to document the fatigue they felt during the treatment.
At 17 and 29 weeks, they will be asked to document the fatigue they feel at that moment.
Measured: 5 weeks, 17 weeks and 29 weeks
Adverse events: muscle contracture
Will only be recorded if present/absent, since there is no scale to measure it
Measured: 5 weeks, 17 weeks and 29 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start18 Dec 2018
- Primary completion31 Jan 2019
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Pro Ayuda del Niño Lisiado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Stuardo, Sociedad Pro Ayuda del Niño Lisiado
- Investigators
- Ines Salas, MD, Study chair, Sociedad Pro Ayuda del Niño Lisiado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780322
- Sponsor's protocol ID
- ArmeoOBPIConcepcion
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12719390Varas 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.
PubMed 19786407Vaquero 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.
PubMed 28650063Andersen 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.
PubMed 19030261Corkum 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.
PubMed 28602269El-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.
PubMed 29199193Pellegrino 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.
PubMed 23714792Yanes 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.
PubMed 25991162Sladekova 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.
PubMed 12098155Ladenheim 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.
PubMed 23949025
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Armeo Spring Pediatric in Children With Narakas I Obstetric Brachial Plexus Injury
- ClinicalTrials.gov ID
- NCT03780322
- Acronym / sponsor ID
- ArmeoOBPIConcepcion
- Keywords
- brachial plexus birth palsy, Armeo®Spring Pediatric, physical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sociedad Pro Ayuda del Niño LisiadoUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstetric brachial plexus injury is caused by damage of the cervical nerve roots C5-T1 during delivery. It has traditionally been treated with occupational and physical therapy during the first few months, evaluating at 1, 3 and 6 months if primary surgery is required. The goal of primary surgery is to repair the damaged nerve roots and restore neural function. Despite surgery, a large percentage of children will remain with varying degrees of paralysis. Since Narakas I ("Erb's") paralysis is the most common, motor sequelae usually involve limited shoulder abduction, restricted shoulder external rotation and elbow flexion contracture. This sequelae requires ongoing physical and occupational therapy, especially during school age, to ensure adequate upper extremity function and participation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armeo Spring Pediatric | Experimental | Device: Armeo Spring PediatricThis group will receive training with Armeo Spring Pediatric in 45 minute sessions, 3 times a week, for a total of 15 sessions |
| Conventional physical and occupational therapy | Active comparator | Other: Conventional physical and occupational therapyThis group will receive combined physical and occupational therapy in 45 minute sessions, 3 times a week, for a total of 15 sessions. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Evident shoulder or elbow dislocation during physical or radiological examination
- Elbow flexion contracture of 40º or more
- Pain during shoulder or elbow manipulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Armeo Spring PediatricBefore 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. | Device | Armeo Spring Pediatric |
| Conventional physical and occupational therapyConventional 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. | Other | Conventional physical and occupational therapy |
Primary outcome
Change in Modified Mallet Scale
Time frame: 0 weeks, 5 weeks, 17 weeks, 29 weeks
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.
4 secondary outcomes
Upper extremity passive range of movement
Time frame: 0 weeks, 5 weeks, 17 weeks and 29 weeks
Adverse events: pain.
Time frame: 5 weeks, 17 weeks and 29 weeks
Adverse events: fatigue
Time frame: 5 weeks, 17 weeks and 29 weeks
Adverse events: muscle contracture
Time frame: 5 weeks, 17 weeks and 29 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 12719390Evans-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.
- BackgroundVaras et al, Eventos Adversos Perinatales: Indicadores epidemiológicos, Revista Obstetricia y Ginecología 2008: 3 (2): 117-122.9
- Background: PubMed 19786407Al-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.
- Background: PubMed 28650063Vaquero 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.
- Background: PubMed 19030261Andersen 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.
- Background: PubMed 28602269Corkum 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.
- Background: PubMed 29199193El-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.
- BackgroundPellegrino 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: PubMed 23714792Arad 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.
- BackgroundYanes 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: PubMed 25991162Gonzalez 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.
- BackgroundSladekova 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Salas, MD study chair
Sociedad Pro Ayuda del Niño Lisiado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Armeo Spring Pediatric and Conventional physical and occupational therapy in people with Brachial Plexus Neuropathies and Brachial Plexus Birth Palsy, run by Sociedad Pro Ayuda del Niño Lisiado at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Mallet Scale (time frame: 0 weeks, 5 weeks, 17 weeks, 29 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780322, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.