CancerNCT04070131
Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects
A study testing Horse-Assisted Rehabilitation in people with Cancer and Child, Only, run by Escoles Universitaries Gimbernat at 2 sites in Spain.
Trial summary
Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cancer, Child, Only, Child Behavior
- What is being tested?
- Horse-Assisted Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Oct 2019to 1 Jun 2022
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System
- With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability
- More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy)
Who cannot join
- Immunodepression
- Hypotonia with severe pelvic instability that does not allow seating on the horse safely
- Weight greater than 80Kg.
- Phobia to horses
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
About this study
Official title: Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics
Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.
Read the detailed description
Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.
- Being tested
- Horse-Assisted Rehabilitation
- Keywords
- Child Behavior, Neurologic Gait Disorder, Cancer, Physical Therapy Modalities, Physical Therapy Specialty, Physical and Rehabilitation Medicine, Rehabilitation
- Medical subject headings
- Neoplasms, Child Behavior, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horse-Assisted RehabilitationOther
Also called Equine-Assisted Rehabilitation, Hippotherapy
One hour weelky session of hippotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Regular follow ups. |
| Intervention Group | Experimental | One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks. Receives: Other: Horse-Assisted Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Quality Of Life Changes
Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).
Measured: Baseline and 25th week
Secondary outcomes (15)
Parent-Proxys Reported Quality Of Life Changes
Pediatric Quality of Life Inventory - Parent-Proxy Report (PedsQL-PC) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).
Measured: Baseline and 25th week
General Health Status Changes
Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).
Measured: Baseline and 25th week
Anxiety Changes
State Trait Ansiety IInventory for children (STAI-CH) - norm-referenced scores (T scores and percentile ranks) for each one of the two subscales: Anxiety-Trait \& Anxiety-State (scores 0-60 in each subscale, higher = worse).
Measured: Baseline and 25th week
Depression Changes
Childhood Depression Inventory (CDI), self report long version (28 items) to assess the presence and severity of depressive symptoms in children. Scores range from 0-56, with higher scores indicating higher levels of depression.
Measured: Baseline and 25th week
Behavior Changes
Behavior Assessment System for Children - Parent Rating Scale (BASC-PRS), second version (BASC-2) - BASC-2 is parent-reported, well-established scale for externalizing/internalizing problem of children and adolescents. Scoring manual and software is provided by the assessment developers; norm-referenced scores (T scores and percentile ranks) are available in the score reports, as are interpretations of strengths and weaknesses and target behaviors for intervention (mean of 50 and standard deviation of 10; for the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic).
Measured: Baseline and 25th week
Self-Reported Physical Function Changes
PedsQL-C (subscale Health and Activities: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Measured: Baseline and 25th week
Parents-Reported Physical Function Changes
PedsQL-PC (subscale Physical Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Measured: Baseline and 25th week
Self-Reported Emotional Function Changes
PedsQL-C (subscale Feelings: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Measured: Baseline and 25th week
Parent-Reported Emotional Function Changes
PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Measured: Baseline and 25th week
Self-Reported Sociability Function Changes
PedsQL-C (subscale Get Along with Others: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Measured: Baseline and 25th week
Parent-Reported Sociability Function Changes
PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Measured: Baseline and 25th week
Balance Changes
Pediatric Balance Scale (PBS: 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks; Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The highest score in PBS is 56, higher is better).
Measured: Baseline, 6th, 12th and 25th week
Position Changes
Sitting Assessment Scale (Sitting Assessment Scale (SAS) is a standardized observational instrument designed for assessment of sitting in children with cerebral palsy (CP); the scale is composed of five items evaluating head, trunk and foot control and arm and hand function, where each item is assessed with a score from 1 to 4 (1 =none; 2=poor; 3=fair; 4=good) and each score (1,2,3,4) has specific decriptors of each item of the SAS).
Measured: Baseline, 6th, 12th and 25th week
Proprioception-Coordination Changes
Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07: the DCDQ is a brief questionnaire designed to screen for coordination disorders in children, aged 5 to 15 years, and consists of 15 items grouped into three distinct factors (motor control during movement, fine motor and handwriting and general coordination; to reach scores, sum each column to compute the numbers onto the Score Sheet, and add all factor scores to compute a Total Score: 0-75, higher is better).
Measured: Baseline and 25th week
Autonomous Neurvous System activation function Changes
Heart Rate Variability (HRV, low/high frequency (LH/FH) power ratio; modulation of heart rate variability assessed through analysis of data collected by HRV wireless monitorisation and PolarH7(R) thoracic band (medical device), following the American and European Cardiological Societies).
Measured: Baseline, 6th, 12th and 25th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2019
- Primary completion1 Feb 2022
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escoles Universitaries Gimbernat
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Sant Joan de Deu
- Responsible party
- Sponsor
- Investigators
- Jordi Esquirol Caussa, PhD, MD, Study director, Escoles Universitàries GimbernatTeresa Xipell Prunés, PT, Principal investigator, Escoles Universitàries Gimbernat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070131
- Sponsor's protocol ID
- HARHB
- Status last verified
- Mar 2022
- First submitted
- 21 Aug 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Signorelli C, Wakefield CE, Fardell JE, Wallace WHB, Robertson EG, McLoone JK, Cohn RJ. The impact of long-term follow-up care for childhood cancer survivors: A systematic review. Crit Rev Oncol Hematol. 2017 Jun;114:131-138. doi: 10.1016/j.critrevonc.2017.04.007. Epub 2017 Apr 13.
PubMed 28477741Miller K, Mehta R, Abraham J, Opneja A, Jain RK. Patterns of Long-term Cancer Survivorship Care in a National Cancer Institute-Designated Comprehensive Cancer Center. Am J Clin Oncol. 2017 Dec;40(6):639-643. doi: 10.1097/COC.0000000000000217.
PubMed 26359697Ford JS, Chou JF, Sklar CA. Attendance at a survivorship clinic: impact on knowledge and psychosocial adjustment. J Cancer Surviv. 2013 Dec;7(4):535-43. doi: 10.1007/s11764-013-0291-9. Epub 2013 Jun 22.
PubMed 23793467Hooke MC, Gilchrist L, Foster L, Langevin M, Lee J. Yoga for Children and Adolescents After Completing Cancer Treatment. J Pediatr Oncol Nurs. 2016 Jan-Feb;33(1):64-73. doi: 10.1177/1043454214563936. Epub 2015 Feb 2.
PubMed 25643973Rigby BR, Grandjean PW. The Efficacy of Equine-Assisted Activities and Therapies on Improving Physical Function. J Altern Complement Med. 2016 Jan;22(1):9-24. doi: 10.1089/acm.2015.0171. Epub 2015 Dec 14.
PubMed 26654868Hilliere C, Collado-Mateo D, Villafaina S, Duque-Fonseca P, Parraca JA. Benefits of Hippotherapy and Horse Riding Simulation Exercise on Healthy Older Adults: A Systematic Review. PM R. 2018 Oct;10(10):1062-1072. doi: 10.1016/j.pmrj.2018.03.019. Epub 2018 Apr 5.
PubMed 29626616Koca TT, Ataseven H. What is hippotherapy? The indications and effectiveness of hippotherapy. North Clin Istanb. 2016 Jan 15;2(3):247-252. doi: 10.14744/nci.2016.71601. eCollection 2015.
PubMed 28058377Cerulli C, Minganti C, De Santis C, Tranchita E, Quaranta F, Parisi A. Therapeutic horseback riding in breast cancer survivors: a pilot study. J Altern Complement Med. 2014 Aug;20(8):623-9. doi: 10.1089/acm.2014.0061. Epub 2014 Jun 25.
PubMed 24963599Lee PT, Dakin E, McLure M. Narrative synthesis of equine-assisted psychotherapy literature: Current knowledge and future research directions. Health Soc Care Community. 2016 May;24(3):225-46. doi: 10.1111/hsc.12201. Epub 2015 Mar 2.
PubMed 25727575Kang KD, Jung TW, Park IH, Han DH. Effects of Equine-Assisted Activities and Therapies on the Affective Network of Adolescents with Internet Gaming Disorder. J Altern Complement Med. 2018 Aug;24(8):841-849. doi: 10.1089/acm.2017.0416. Epub 2018 Apr 26.
PubMed 29698054Pendry P, Carr AM, Smith AN, Roeter SM. Improving adolescent social competence and behavior: a randomized trial of an 11-week equine facilitated learning prevention program. J Prim Prev. 2014 Aug;35(4):281-93. doi: 10.1007/s10935-014-0350-7.
PubMed 24898318Garner BA, Rigby BR. Human pelvis motions when walking and when riding a therapeutic horse. Hum Mov Sci. 2015 Feb;39:121-37. doi: 10.1016/j.humov.2014.06.011. Epub 2014 Nov 28.
PubMed 25436916Fazio E, Medica P, Cravana C, Ferlazzo A. Hypothalamic-pituitary-adrenal axis responses of horses to therapeutic riding program: effects of different riders. Physiol Behav. 2013 Jun 13;118:138-43. doi: 10.1016/j.physbeh.2013.05.009. Epub 2013 May 15.
PubMed 23684906Herrero Gallego P, García Antón E, Monserrat Cantera ME, Oliván Blázquez B, Gómez Trullén EM, Trenado Molina J. Efectos terapéuticos de la hipoterapia en la parálisis cerebral, una revisión sistemática. Fisioterapia. 2012; 34:225-34.
Tseng SH, Chen HC, Tam KW. Systematic review and meta-analysis of the effect of equine assisted activities and therapies on gross motor outcome in children with cerebral palsy. Disabil Rehabil. 2013 Jan;35(2):89-99. doi: 10.3109/09638288.2012.687033. Epub 2012 May 26.
PubMed 22630812
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics
- ClinicalTrials.gov ID
- NCT04070131
- Acronym / sponsor ID
- HARHB
- Keywords
- Child Behavior, Neurologic Gait Disorder, Cancer, Physical Therapy Modalities, Physical Therapy Specialty, Physical and Rehabilitation Medicine, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Escoles Universitaries GimbernatUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Sant Joan de Deu
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 28 Aug 2019 (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.
Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.
Detailed description
Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Regular follow ups. |
| Intervention Group | Experimental | Other: Horse-Assisted RehabilitationOne weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System
- With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability
- More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy)
Key exclusion criteria (4 listed)
- Immunodepression
- Hypotonia with severe pelvic instability that does not allow seating on the horse safely
- Weight greater than 80Kg.
- Phobia to horses
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 |
|---|---|---|
| Horse-Assisted RehabilitationAlso: Equine-Assisted Rehabilitation, HippotherapyOne hour weelky session of hippotherapy. | Other | Intervention Group |
Primary outcome
Self-Reported Quality Of Life Changes
Time frame: Baseline and 25th week
Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).
15 secondary outcomes
Parent-Proxys Reported Quality Of Life Changes
Time frame: Baseline and 25th week
General Health Status Changes
Time frame: Baseline and 25th week
Anxiety Changes
Time frame: Baseline and 25th week
Depression Changes
Time frame: Baseline and 25th week
Behavior Changes
Time frame: Baseline and 25th week
Self-Reported Physical Function Changes
Time frame: Baseline and 25th week
Parents-Reported Physical Function Changes
Time frame: Baseline and 25th week
Self-Reported Emotional Function Changes
Time frame: Baseline and 25th week
Parent-Reported Emotional Function Changes
Time frame: Baseline and 25th week
Self-Reported Sociability Function Changes
Time frame: Baseline and 25th week
Parent-Reported Sociability Function Changes
Time frame: Baseline and 25th week
Balance Changes
Time frame: Baseline, 6th, 12th and 25th week
Position Changes
Time frame: Baseline, 6th, 12th and 25th week
Proprioception-Coordination Changes
Time frame: Baseline and 25th week
Autonomous Neurvous System activation function Changes
Time frame: Baseline, 6th, 12th and 25th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 28477741Signorelli C, Wakefield CE, Fardell JE, Wallace WHB, Robertson EG, McLoone JK, Cohn RJ. The impact of long-term follow-up care for childhood cancer survivors: A systematic review. Crit Rev Oncol Hematol. 2017 Jun;114:131-138. doi: 10.1016/j.critrevonc.2017.04.007. Epub 2017 Apr 13.
- Background: PubMed 26359697Miller K, Mehta R, Abraham J, Opneja A, Jain RK. Patterns of Long-term Cancer Survivorship Care in a National Cancer Institute-Designated Comprehensive Cancer Center. Am J Clin Oncol. 2017 Dec;40(6):639-643. doi: 10.1097/COC.0000000000000217.
- Background: PubMed 23793467Ford JS, Chou JF, Sklar CA. Attendance at a survivorship clinic: impact on knowledge and psychosocial adjustment. J Cancer Surviv. 2013 Dec;7(4):535-43. doi: 10.1007/s11764-013-0291-9. Epub 2013 Jun 22.
- Background: PubMed 25643973Hooke MC, Gilchrist L, Foster L, Langevin M, Lee J. Yoga for Children and Adolescents After Completing Cancer Treatment. J Pediatr Oncol Nurs. 2016 Jan-Feb;33(1):64-73. doi: 10.1177/1043454214563936. Epub 2015 Feb 2.
- Background: PubMed 26654868Rigby BR, Grandjean PW. The Efficacy of Equine-Assisted Activities and Therapies on Improving Physical Function. J Altern Complement Med. 2016 Jan;22(1):9-24. doi: 10.1089/acm.2015.0171. Epub 2015 Dec 14.
- Background: PubMed 29626616Hilliere C, Collado-Mateo D, Villafaina S, Duque-Fonseca P, Parraca JA. Benefits of Hippotherapy and Horse Riding Simulation Exercise on Healthy Older Adults: A Systematic Review. PM R. 2018 Oct;10(10):1062-1072. doi: 10.1016/j.pmrj.2018.03.019. Epub 2018 Apr 5.
- Background: PubMed 28058377Koca TT, Ataseven H. What is hippotherapy? The indications and effectiveness of hippotherapy. North Clin Istanb. 2016 Jan 15;2(3):247-252. doi: 10.14744/nci.2016.71601. eCollection 2015.
- Background: PubMed 24963599Cerulli C, Minganti C, De Santis C, Tranchita E, Quaranta F, Parisi A. Therapeutic horseback riding in breast cancer survivors: a pilot study. J Altern Complement Med. 2014 Aug;20(8):623-9. doi: 10.1089/acm.2014.0061. Epub 2014 Jun 25.
- Background: PubMed 25727575Lee PT, Dakin E, McLure M. Narrative synthesis of equine-assisted psychotherapy literature: Current knowledge and future research directions. Health Soc Care Community. 2016 May;24(3):225-46. doi: 10.1111/hsc.12201. Epub 2015 Mar 2.
- Background: PubMed 29698054Kang KD, Jung TW, Park IH, Han DH. Effects of Equine-Assisted Activities and Therapies on the Affective Network of Adolescents with Internet Gaming Disorder. J Altern Complement Med. 2018 Aug;24(8):841-849. doi: 10.1089/acm.2017.0416. Epub 2018 Apr 26.
- Background: PubMed 24898318Pendry P, Carr AM, Smith AN, Roeter SM. Improving adolescent social competence and behavior: a randomized trial of an 11-week equine facilitated learning prevention program. J Prim Prev. 2014 Aug;35(4):281-93. doi: 10.1007/s10935-014-0350-7.
- Background: PubMed 25436916Garner BA, Rigby BR. Human pelvis motions when walking and when riding a therapeutic horse. Hum Mov Sci. 2015 Feb;39:121-37. doi: 10.1016/j.humov.2014.06.011. Epub 2014 Nov 28.
- 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.
Jordi Esquirol Caussa, PhD, MD study director
Escoles Universitàries Gimbernat
Teresa Xipell Prunés, PT principal investigator
Escoles Universitàries Gimbernat
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horse-Assisted Rehabilitation in people with Cancer and Child, Only, run by Escoles Universitaries Gimbernat at 2 sites in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
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?
Self-Reported Quality Of Life Changes (time frame: Baseline and 25th week). 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 NCT04070131, which also lists 56 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 23 Mar 2022.