Cerebral PalsyNCT04554238
Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin
A study testing Armeo spring and Occupational Therapy in people with Cerebral Palsy and Upper Extremity Paresis, run by Sociedad Pro Ayuda del Niño Lisiado at 1 site in Chile.
Trial summary
Background: Unilateral spastic cerebral palsy (CP) generates an impact on daily activities, mainly due to the functional limitation of the affected upper limb. The use of technologies such as Armeo spring robotic therapy seeks to improve upper limb mobility through innovative and motivating training that facilitates… Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity Paresis
- What is being tested?
- Armeo spring and Occupational Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChile
- Study dates
- 1 Nov 2018to 30 Jul 2019
- Phase
- Interventional
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Unilateral spastic cerebral palsy
- Botulinum toxin infiltration 3 weeks before start
- Manual Ability Classification scale in level I, II and III
Who cannot join
- Fixed upper extremity contractures
- Not integrate their affected upper limb into activity.
- Difficult to follow instructions
- Epileptic seizures
- Osteoporosis
- Instability in vital pulmonary or cardiovascular functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin: Single-blind, Parallel Group Randomized Clinical Trial
Background: Unilateral spastic cerebral palsy (CP) generates an impact on daily activities, mainly due to the functional limitation of the affected upper limb. The use of technologies such as Armeo spring robotic therapy seeks to improve upper limb mobility through innovative and motivating training that facilitates movement.
Objective: To assess the effectiveness of Armeo spring robotic therapy versus conventional occupational therapy regarding the changes in upper limb functionality of children with unilateral spastic CP infiltrated simultaneously with botulinum toxin A (BTA).
Read more
Patients and methods: Randomized clinical trial of parallel groups, in children between 4 and 10 years of age diagnosed with unilateral spastic CP and infiltrates with BTA, who received treatment of conventional occupational therapy (group I) or Armeo spring robotic therapy (group II). The intervention consists of 15 sessions of 40 minutes for 5 weeks, 3 times a week. An initial evaluation is applied with QUEST, ABILHAND-Kids, and MACS, which are re-evaluated at 3 and 6 months.
Hypothesis: Armeo spring robotic therapy will obtain better results than conventional occupational therapy in relation to the functionality of the upper limb at the level of manipulative function, quality of movement of the limb and the performance of daily activities.
Expected results: The results of the QUEST and ABILHAND-Kids dimensions assessed before, after and at follow-up will be the primary outcome. The presence of adverse effects will correspond to secondary outcome.
Benefit and limitations: Direct social contribution for patient's rehabilitation by using technology and a contribution to research to update scientific evidence. Possible limitations could be presence of adverse effects and poor adherence to treatment.
Read the detailed description
The study will contemplate the description of the clinical characteristics of the patients to intervene (sex, age, locality and Manual Classification of Skills system in children with CP - MACS), and the main results consider the quality upper extremity skills test and the questionnaire of Abilhand-kids. Among the secondary outcomes, the presence of adverse effects and adherence to the intervention will be considered, through the record of attendance at the sessions.In relation to standard operating procedures, no statistical calculation of the sample size will be performed as the entire available population will be covered. All children with spastic unilateral Cerebral Palsy between 4 and 10 years of the year 2018 will be selected at Instituto Teletón in the city of Concepción, Chile. The list of those who have recently been infiltrated with botulinum toxin type A in the upper limb and those who have an indication for admission to treatment will be reviewed. A list will be made with the selected users, assigning the child a number for random selection to a specific study group. The list will be sent to the Subdirección de Investigación - Dirección Médica Nacional of Teletón Chile to maintain the masking.
Participants will be randomly assigned using specialized software to the study group (Armeo) and the control group (conventional therapy) to ensure that each participant has an equal probability of being assigned to either of the two groups. After finishing the Armeo spring group treatment and conventional Occupational Therapy, a post-intervention evaluation will be performed at 3 months and follow-up at 6 months.The data collection will be carried out later, through specific sources: clinical history, interview, evaluation guideline, clinical observation and attendance record. To guarantee the registration procedure, it will be determined that at the end of each evaluation period (initial evaluation, post intervention and follow-up) the evaluator will immediately transfer the information to the database, and it will be verified that it matches the evaluated user through the clinical history number assigned.
The processing and statistical analysis of the data will be coded in an Excel spreadsheet and will be processed using statistical software SPSS v17.0. A normality test will be performed to verify the distribution of the data. According to this result, the corresponding position and dispersion measures will be obtained. To contrast the values of the intragroup variables at the different evaluation times, repeated measures tests will be used and, to evaluate the differences between the study groups, T test or Kruskal Wallis tests will be used, considering a level of significance of 5%. As safety considerations for participants, it is that the treatment will be suspended in the event of the presence of adverse events, for example, skin lesions, pain and fatigue.
- Conditions
- Cerebral Palsy, Upper Extremity Paresis
- Being tested
- Armeo spring, Occupational Therapy
- Keywords
- Unilateral Cerebral Palsy, Upper extremity function, Armeo spring, Occupational Therapy.
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo springDevice
Armeo spring is an exoskeleton that allows intensive therapy aimed at upper extremity tasks, which can be regulated according to the anthropometric measurements of the child and the objective of the session. The software contains an extensive library of game-like exercises that are run in a motivating and informative virtual reality training environment, clearly showing the functional task to be performed through immediate feedback in a 3D work space.
Occupational TherapyOther
This treatment includes passive stretching exercises, weight bearing, stimulation of protective reactions, muscle strengthening exercises and different types of motivating bimanual games, favoring reaching, grasping, exploration and manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Armeo spring group | Experimental | Regarding masking, it is impossible for the treating occupational therapist to be unaware of the treatment to be carried out by the treated patient, just as it is impossible for the patient not to identify the treatment to which they access, therefore, this study is single-blind, considering only who performs the evaluations of the study will not know which group corresponds to the evaluated patient. Receives: Device: Armeo spring |
| Occupational Therapy group | Active comparator | It consists of 5 weeks of intervention, with 3 treatment sessions per week, 40 minutes each time. The patient performs active exercises of the paretic upper limb: bimanual play activities, weight bearing, reaches in various planes of motion that favor shoulder flexion, elbow extension, forearm supination, and dissociated finger movements. In addition to passive mobilizations of the shoulder, elbow and wrist and tactile and proprioceptive sensory stimulation and the use of paretic limbs as support or carrying out prehensions. Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of "Quality of Upper Extremity Skills Test" score at 3 and 6 months post intervention
The Quality Upper Extremity Ability Test (QUEST) assesses the quality of upper extremity function in four domains: dissociated movements, grip, protective extension, and weight-bearing. It was designed to evaluate children with neuromotor dysfunction with spasticity and has been validated in children 18 to 8 years of age.
The scale presents a specific score for each dimension, which is added, and the final value that is transformed into a final percentage (0-100%). This percentage obtained is the one that is statistically analyzed, understanding that a higher percentage represents a better quality of movement.
The QUEST allows an evaluation of the quality of the movements of one and two hands in individuals with CP but does not allow an evaluation of the quality of life.
Measured: Before, after the interventions (3 months) and 6 months follow-up
Secondary outcomes (1)
Change from Baseline of "Measure of manual ability for children with upper limb impairments; ABILHAND-kids" score at 3 and 6 months post intervention
The ABILHAND-Kids scale (measure of manual ability for children with upper limb impairments) consists of 21 items, mostly bimanual, rated by the parents. Parents report a better perception of their children's ability than the children themselves.
On this scale, each task had a numerical assignment according to the difficulty perceived by the father: easy = 1; difficult = 2 and impossible = 3, from which the average was obtained, which was statistically analyzed. It is considered that the decrease in the values corresponds to a perception of a greater number of activities that are easy to carry out by the child.
ABILHAND-Kids is responsive to detect changes after clinical trials using intensive training in children with unilateral CP. Therefore, this scale is potentially useful for assessing functional status.
Measured: Before, after the interventions (3 months) and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Nov 2018
- Primary completion1 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The type of study to be developed corresponds to a parallel group randomized clinical trial (RCT) with a superiority study framework, as it seeks to compare the effectiveness of Armeo spring robotic therapy versus conventional occupational therapy in terms of the functionality of the upper limb of children with hemiparesis infiltrated simultaneously with BTA. The trial phase corresponds to phase III.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Pro Ayuda del Niño Lisiado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554238
- Sponsor's protocol ID
- SDI2019026
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not, the information from the database will not be provided, since the tutors signed an authorization to participate and deliver the general results of the research, but authorization is not requested to deliver individual data.
Publications
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Klingels K, Demeyere I, Jaspers E, De Cock P, Molenaers G, Boyd R, Feys H. Upper limb impairments and their impact on activity measures in children with unilateral cerebral palsy. Eur J Paediatr Neurol. 2012 Sep;16(5):475-84. doi: 10.1016/j.ejpn.2011.12.008. Epub 2012 Jan 13.
PubMed 22244966Pierce SR, Daly K, Gallagher KG, Gershkoff AM, Schaumburg SW. Constraint-induced therapy for a child with hemiplegic cerebral palsy: a case report. Arch Phys Med Rehabil. 2002 Oct;83(10):1462-3. doi: 10.1053/apmr.2002.34832.
PubMed 12370887Brown JK, van Rensburg F, Walsh G, Lakie M, Wright GW. A neurological study of hand function of hemiplegic children. Dev Med Child Neurol. 1987 Jun;29(3):287-304. doi: 10.1111/j.1469-8749.1987.tb02482.x.
PubMed 3596065Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162.
PubMed 16780622El-Shamy SM. Efficacy of Armeo(R) Robotic Therapy Versus Conventional Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy. Am J Phys Med Rehabil. 2018 Mar;97(3):164-169. doi: 10.1097/PHM.0000000000000852.
PubMed 29059068Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, Detrembleur C, Lejeune TM, Stoquart G. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb;29(2):183-92. doi: 10.1177/1545968314541172. Epub 2014 Jul 11.
PubMed 25015650
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin: Single-blind, Parallel Group Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04554238
- Acronym / sponsor ID
- SDI2019026
- Conditions
- Cerebral Palsy, Upper Extremity Paresis
- Keywords
- Unilateral Cerebral Palsy, Upper extremity function, Armeo spring, Occupational Therapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sociedad Pro Ayuda del Niño LisiadoUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 18 Sep 2020 (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.
Background: Unilateral spastic cerebral palsy (CP) generates an impact on daily activities, mainly due to the functional limitation of the affected upper limb. The use of technologies such as Armeo spring robotic therapy seeks to improve upper limb mobility through innovative and motivating training that facilitates movement.
Objective: To assess the effectiveness of Armeo spring robotic therapy versus conventional occupational therapy regarding the changes in upper limb functionality of children with unilateral spastic CP infiltrated simultaneously with botulinum toxin A (BTA).
Patients and methods: Randomized clinical trial of parallel groups, in children between 4 and 10 years of age diagnosed with unilateral spastic CP and infiltrates with BTA, who received treatment of conventional occupational therapy (group I) or Armeo spring robotic therapy (group II). The intervention consists of 15 sessions of 40 minutes for 5 weeks, 3 times a week. An initial evaluation is applied with QUEST, ABILHAND-Kids, and MACS, which are re-evaluated at 3 and 6 months.
Hypothesis: Armeo spring robotic therapy will obtain better results than conventional occupational therapy in relation to the functionality of the upper limb at the level of manipulative function, quality of movement of the limb and the performance of daily activities.
Expected results: The results of the QUEST and ABILHAND-Kids dimensions assessed before, after and at follow-up will be the primary outcome. The presence of adverse effects will correspond to secondary outcome.
Benefit and limitations: Direct social contribution for patient's rehabilitation by using technology and a contribution to research to update scientific evidence. Possible limitations could be presence of adverse effects and poor adherence to treatment.
Detailed description
The study will contemplate the description of the clinical characteristics of the patients to intervene (sex, age, locality and Manual Classification of Skills system in children with CP - MACS), and the main results consider the quality upper extremity skills test and the questionnaire of Abilhand-kids. Among the secondary outcomes, the presence of adverse effects and adherence to the intervention will be considered, through the record of attendance at the sessions.In relation to standard operating procedures, no statistical calculation of the sample size will be performed as the entire available population will be covered. All children with spastic unilateral Cerebral Palsy between 4 and 10 years of the year 2018 will be selected at Instituto Teletón in the city of Concepción, Chile. The list of those who have recently been infiltrated with botulinum toxin type A in the upper limb and those who have an indication for admission to treatment will be reviewed. A list will be made with the selected users, assigning the child a number for random selection to a specific study group. The list will be sent to the Subdirección de Investigación - Dirección Médica Nacional of Teletón Chile to maintain the masking.
Participants will be randomly assigned using specialized software to the study group (Armeo) and the control group (conventional therapy) to ensure that each participant has an equal probability of being assigned to either of the two groups. After finishing the Armeo spring group treatment and conventional Occupational Therapy, a post-intervention evaluation will be performed at 3 months and follow-up at 6 months.The data collection will be carried out later, through specific sources: clinical history, interview, evaluation guideline, clinical observation and attendance record. To guarantee the registration procedure, it will be determined that at the end of each evaluation period (initial evaluation, post intervention and follow-up) the evaluator will immediately transfer the information to the database, and it will be verified that it matches the evaluated user through the clinical history number assigned.
The processing and statistical analysis of the data will be coded in an Excel spreadsheet and will be processed using statistical software SPSS v17.0. A normality test will be performed to verify the distribution of the data. According to this result, the corresponding position and dispersion measures will be obtained. To contrast the values of the intragroup variables at the different evaluation times, repeated measures tests will be used and, to evaluate the differences between the study groups, T test or Kruskal Wallis tests will be used, considering a level of significance of 5%. As safety considerations for participants, it is that the treatment will be suspended in the event of the presence of adverse events, for example, skin lesions, pain and fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The type of study to be developed corresponds to a parallel group randomized clinical trial (RCT) with a superiority study framework, as it seeks to compare the effectiveness of Armeo spring robotic therapy versus conventional occupational therapy in terms of the functionality of the upper limb of children with hemiparesis infiltrated simultaneously with BTA. The trial phase corresponds to phase III.
| Arm | Type | Receives |
|---|---|---|
| Armeo spring group | Experimental | Device: Armeo springRegarding masking, it is impossible for the treating occupational therapist to be unaware of the treatment to be carried out by the treated patient, just as it is impossible for the patient not to identify the treatment to which they access, therefore, this study is single-blind, considering only who performs the evaluations of the study will not know which group corresponds to the evaluated patient. |
| Occupational Therapy group | Active comparator | Other: Occupational TherapyIt consists of 5 weeks of intervention, with 3 treatment sessions per week, 40 minutes each time. The patient performs active exercises of the paretic upper limb: bimanual play activities, weight bearing, reaches in various planes of motion that favor shoulder flexion, elbow extension, forearm supination, and dissociated finger movements. In addition to passive mobilizations of the shoulder, elbow and wrist and tactile and proprioceptive sensory stimulation and the use of paretic limbs as support or carrying out prehensions. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of Unilateral spastic cerebral palsy
- Botulinum toxin infiltration 3 weeks before start
- Manual Ability Classification scale in level I, II and III
Key exclusion criteria (6 listed)
- Fixed upper extremity contractures
- Not integrate their affected upper limb into activity.
- Difficult to follow instructions
- Epileptic seizures
- Osteoporosis
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 springArmeo spring is an exoskeleton that allows intensive therapy aimed at upper extremity tasks, which can be regulated according to the anthropometric measurements of the child and the objective of the session. The software contains an extensive library of game-like exercises that are run in a motivating and informative virtual reality training environment, clearly showing the functional task to be performed through immediate feedback in a 3D work space. | Device | Armeo spring group |
| Occupational TherapyThis treatment includes passive stretching exercises, weight bearing, stimulation of protective reactions, muscle strengthening exercises and different types of motivating bimanual games, favoring reaching, grasping, exploration and manipulation. | Other | Occupational Therapy group |
Primary outcome
Change from Baseline of "Quality of Upper Extremity Skills Test" score at 3 and 6 months post intervention
Time frame: Before, after the interventions (3 months) and 6 months follow-up
The Quality Upper Extremity Ability Test (QUEST) assesses the quality of upper extremity function in four domains: dissociated movements, grip, protective extension, and weight-bearing. It was designed to evaluate children with neuromotor dysfunction with spasticity and has been validated in children 18 to 8 years of age. The scale presents a specific score for each dimension, which is added, and the final value that is transformed into a final percentage (0-100%). This percentage obtained is the one that is statistically analyzed, understanding that a higher percentage represents a better quality of movement. The QUEST allows an evaluation of the quality of the movements of one and two hands in individuals with CP but does not allow an evaluation of the quality of life.
1 secondary outcome
Change from Baseline of "Measure of manual ability for children with upper limb impairments; ABILHAND-kids" score at 3 and 6 months post intervention
Time frame: Before, after the interventions (3 months) and 6 months follow-up
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 18 Sep 2020.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 22244966Klingels K, Demeyere I, Jaspers E, De Cock P, Molenaers G, Boyd R, Feys H. Upper limb impairments and their impact on activity measures in children with unilateral cerebral palsy. Eur J Paediatr Neurol. 2012 Sep;16(5):475-84. doi: 10.1016/j.ejpn.2011.12.008. Epub 2012 Jan 13.
- Background: PubMed 12370887Pierce SR, Daly K, Gallagher KG, Gershkoff AM, Schaumburg SW. Constraint-induced therapy for a child with hemiplegic cerebral palsy: a case report. Arch Phys Med Rehabil. 2002 Oct;83(10):1462-3. doi: 10.1053/apmr.2002.34832.
- Background: PubMed 3596065Brown JK, van Rensburg F, Walsh G, Lakie M, Wright GW. A neurological study of hand function of hemiplegic children. Dev Med Child Neurol. 1987 Jun;29(3):287-304. doi: 10.1111/j.1469-8749.1987.tb02482.x.
- Background: PubMed 16780622Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162.
- Results publication: PubMed 29059068El-Shamy SM. Efficacy of Armeo(R) Robotic Therapy Versus Conventional Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy. Am J Phys Med Rehabil. 2018 Mar;97(3):164-169. doi: 10.1097/PHM.0000000000000852.
- Results publication: PubMed 25015650Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, Detrembleur C, Lejeune TM, Stoquart G. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb;29(2):183-92. doi: 10.1177/1545968314541172. Epub 2014 Jul 11.
- Individual participant dataSharing planned: No. Not, the information from the database will not be provided, since the tutors signed an authorization to participate and deliver the general results of the research, but authorization is not requested to deliver individual data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armeo spring and Occupational Therapy in people with Cerebral Palsy and Upper Extremity Paresis, 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 6 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 18 Sep 2020. 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.
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 from Baseline of "Quality of Upper Extremity Skills Test" score at 3 and 6 months post intervention (time frame: Before, after the interventions (3 months) and 6 months follow-up). 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 NCT04554238, which also lists 7 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 18 Sep 2020.