Physical TherapyFIMAPACENCT04778930
Physical Therapy for Improving Functionality, Gait and Participation in Cerebral Palsy
A study testing Physical Therapy and THERAPEUTIC EDUCATION PROGRAM in people with Physical Therapy and Cerebral Palsy, run by University of Alcala at 1 site in Spain.
Trial summary
Cerebral Palsy is a non-progressive nature lesion of the Central Nervous System, with a wide spectrum of impairments at body structure and function, which has a great impact at activity and participation in the environment. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Physical Therapy, Cerebral Palsy, Therapeutic Education
- What is being tested?
- Physical Therapy and THERAPEUTIC EDUCATION PROGRAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 31 Dec 2023
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GMFCS (I-III); MACS (I-III); CFCS (I-III)
Who cannot join
- having undergone surgery on lower limbs in the 6 months prior to his participation in the study; having surgery during the study; inability to follow the planned program due to moving to other city or other reason.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Physiotherapy Neuromusculoskeletal in life stages Research Group - FINEMEV
Alcalá de Henares, Madrid, 28005
Soraya Pacheco da Costa, 661855923, soraya.pacheco@uah.es
About this study
Official title: Effectiveness of Physical Therapy for Improving the Functionality, Gait and Participation in the Environment in Children and Adolescents With Cerebral Palsy: Randomized Clinical Trial
Cerebral Palsy is a non-progressive nature lesion of the Central Nervous System, with a wide spectrum of impairments at body structure and function, which has a great impact at activity and participation in the environment. The intensity of participation is influenced by multiple factors, among which independent mobility stands out, through the functional activity of walking. Children and adolescents with Cerebral Palsy present limitations in gait function both at the level of body structure and activity and improving these aspects is one of the main therapeutic objectives in their treatment.
Physical Therapy interventions based on task learning and achieving objectives have proven to be effective in improving functional skills, gait and participation.
Read more
Due to COVID-19, interventions have been interrupted or reduced in periodicity. For this reason, it is essential to provide alternatives to Physical Therapy interventions for children and adolescents with Cerebral Palsy. Telehealth may play an important role both in maintaining function and in monitoring individuals, in addition to bringing the Physical Therapist closer to the natural environment of the child / adolescent through digital platforms.
Therefore the aim of this clinical trial is to verify that a Physiotherapy intervention that combines face-to-face sessions with telecare in natural settings is effective in improving the functional activity of walking and participation in the environment of children and adolescents with Cerebral Palsy.
The study population are children and adolescents diagnosed with Cerebral Palsy; ages 6-17 years old. The sample of 50 subjects (25 in each group) will be recruited in care centers for children and adolescents with Cerebral Palsy in Alcalá de Henares.
The outcome variables are: participation in the environment (Spanish version of the Children's Assessment of Participation and Enjoyment - CAPE), gait speed (10-meter walk test - 10MM), gait endurance (6-minute walk test - 6MM), gross motor function (Spanish version of the Gross Motor Function Measure - GMFM-SP) and static and dynamic balance (Spanish version of the Pediatric Balance Scale - PBS). They will be collected in three moments: baseline assessment (V0); intermediate assessment (V1) at 6 weeks at the end of each group intervention; Final assessment (V2) 3 months after baseline.
Read the detailed description
Group A Physical Therapy intervention group will receive 18 sessions, 3 times a week, for 6 consecutive weeks; on the one hand, 12 face-to-face sessions of approximately 90 minutes duration, in which the Physical Therapy treatment will be carried out based on training of specific tasks directed to objectives and training of gait with a treadmill; In addition, a therapeutic education program will be carried out, with 6 telehealth sessions, which will include action observation therapy. Subjects in Group B (control group) will receive their usual Physiotherapy intervention regimen for 6 weeks at their referral center and the same telehealth Therapeutic Education program of the intervention group. The face-to-face sessions of the intervention group will be carried out in the Physiotherapy Teaching Unit of the University of Alcalá, and the telehealth sessions of the Therapeutic Education program of both groups will be carried out by remote assistance through a digital platform. All will be carried out by specialist Physiotherapists, members of the research team.
Statistical Analysis: After assessments, the data will be analyzed to verify the results. It will be done: descriptive analysis of the sample (means, medians, standard deviations and quartiles; normality test; frequency distributions): homogeneity check of the groups (t-Student or Mann Withney's U - quantitative variables; Chi square or F of Fisher - categorical variables); effectiveness analysis (parametric tests or not of paired samples; multivariate models to adjust for possible confounding factors; multivariate model of repeated measures to evaluate the result of the intervention. The statistical package Statistical Package for the Social Sciences software (25 version , SPSS Inc, Chicago, USA) or the statistical package STATA MP v14.2 (StataCo)
- Conditions
- Physical Therapy, Cerebral Palsy, Therapeutic Education, Telehealth
- Being tested
- Physical Therapy, THERAPEUTIC EDUCATION PROGRAM
- Keywords
- Physical Therapy, Cerebral Palsy, Telehealth, Therapeutic Education
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Also called Therapeutic Education, Family centered model, Action Observation Therapy, Goal-directed training
FACE-TO FACE SESSIONS: approximately 90 minutes of Goal-directed training (activities for the activation of the muscles of the trunk, pelvis and lower limbs; and training of activities will be carried out in a functional and meaningful context, aimed at specific functional objectives, according to the interests of each participant and agreed with the participants and their families) and gait training on the treadmill for 20 minutes.
TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation.
THERAPEUTIC EDUCATION PROGRAMOther
TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Group A_Intervention Group | Experimental | It will consist of 18 sessions, 3 times a week, for 6 consecutive weeks; on the one hand, 12 face-to-face sessions of approximately 90 minutes duration, in which the Physical Therapy treatment will be carried out based on training of specific tasks directed to objectives and training of gait with a treadmill; In addition, a therapeutic education program will be carried out, with 6 telehealth sessions lasting approximately 60 minutes, which will include action observation activities. The face-to-face sessions will be held at the Physical Therapy Teaching Unit at University of Alcalá, and the telehealth sessions of the Therapeutic Education program will be carried out by remote assistance through a digital platform. All will be carried out by specialist Physical Therapists, members of the research team. Receives: Other: Physical Therapy; Other: THERAPEUTIC EDUCATION PROGRAM |
| Group B_Control Group | Experimental | The subjects in this group will receive their usual Physical Therapy intervention regimen for 6 weeks at their referral center and the same telehealth Therapeutic Education program of the intervention group. Receives: Other: THERAPEUTIC EDUCATION PROGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Environmental participation at 6 weeks and 3 months
Spanish version of Children's Assessment of Participation and Enjoyment (CAPE)
Measured: Baseline assessment
Change in baseline Gait speed at 6 weeks and 3 months
10 meter walk Test
Measured: Baseline assessment
Change in baseline Gait endurance at 6 weeks and 3 months
6 minutes walk test
Measured: Baseline assessment
Change in baseline Gross Motor Function at 6 weeks and 3 months
Spanish version of Gross Motor Function Measure (GMFM-SP)
Measured: Baseline assessment
Change in baseline Static and Dynamic Balance at 6 weeks and 3 months
Spanish version of Pediatric Balance Scale (PBS)
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Feb 2022
- Primary completion30 Jan 2023
- Study completion31 Dec 2023 (estimated)
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 Physical TherapyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soraya Pacheco da Costa, University of Alcala
- Investigators
- Soraya Pacheco da Costa, PhD, Principal investigator, University Professor Physical Therapy Degree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778930
- Sponsor's protocol ID
- SCosta
- Acronym
- FIMAPACE
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
PubMed 32086598Sellier E, McIntyre S, Smithers-Sheedy H, Platt MJ; SCPE and ACPR Groups. European and Australian Cerebral Palsy Surveillance Networks Working Together for Collaborative Research. Neuropediatrics. 2020 Apr;51(2):105-112. doi: 10.1055/s-0039-3402003. Epub 2020 Jan 7.
PubMed 31910452Schiariti V, Mahdi S, Bolte S. International Classification of Functioning, Disability and Health Core Sets for cerebral palsy, autism spectrum disorder, and attention-deficit-hyperactivity disorder. Dev Med Child Neurol. 2018 Sep;60(9):933-941. doi: 10.1111/dmcn.13922. Epub 2018 May 30.
PubMed 29845609Chakraborty S, Nandy A, Kesar TM. Gait deficits and dynamic stability in children and adolescents with cerebral palsy: A systematic review and meta-analysis. Clin Biomech (Bristol). 2020 Jan;71:11-23. doi: 10.1016/j.clinbiomech.2019.09.005. Epub 2019 Oct 18.
PubMed 31677546Toovey R, Bernie C, Harvey AR, McGinley JL, Spittle AJ. Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review. BMJ Paediatr Open. 2017 Aug 11;1(1):e000078. doi: 10.1136/bmjpo-2017-000078. eCollection 2017.
PubMed 29637118Han YG, Yun CK. Effectiveness of treadmill training on gait function in children with cerebral palsy: meta-analysis. J Exerc Rehabil. 2020 Feb 26;16(1):10-19. doi: 10.12965/jer.1938748.374. eCollection 2020 Feb.
PubMed 32161730Pacheco-da-Costa S, Rodriguez-Costa I, Abuin-Porras V, Asunsolo-Del-Barco A, Calvo-Fuente V, Soto-Vidal C. Effectiveness of Physiotherapy for Improving Participation, Gross Motor Function, Gait and Balance in Children and Adolescents with Cerebral Palsy: Study Protocol for a Randomized Controlled Trial. J Clin Med. 2025 Mar 24;14(7):2214. doi: 10.3390/jcm14072214.
PubMed 40217665
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy for Improving the Functionality, Gait and Participation in the Environment in Children and Adolescents With Cerebral Palsy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04778930
- Acronym / sponsor ID
- FIMAPACE / SCosta
- Conditions
- Physical Therapy, Cerebral Palsy, Therapeutic Education, Telehealth
- Keywords
- Physical Therapy, Cerebral Palsy, Telehealth, Therapeutic Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Mar 2021 (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.
Cerebral Palsy is a non-progressive nature lesion of the Central Nervous System, with a wide spectrum of impairments at body structure and function, which has a great impact at activity and participation in the environment. The intensity of participation is influenced by multiple factors, among which independent mobility stands out, through the functional activity of walking. Children and adolescents with Cerebral Palsy present limitations in gait function both at the level of body structure and activity and improving these aspects is one of the main therapeutic objectives in their treatment.
Physical Therapy interventions based on task learning and achieving objectives have proven to be effective in improving functional skills, gait and participation.
Due to COVID-19, interventions have been interrupted or reduced in periodicity. For this reason, it is essential to provide alternatives to Physical Therapy interventions for children and adolescents with Cerebral Palsy. Telehealth may play an important role both in maintaining function and in monitoring individuals, in addition to bringing the Physical Therapist closer to the natural environment of the child / adolescent through digital platforms.
Therefore the aim of this clinical trial is to verify that a Physiotherapy intervention that combines face-to-face sessions with telecare in natural settings is effective in improving the functional activity of walking and participation in the environment of children and adolescents with Cerebral Palsy.
The study population are children and adolescents diagnosed with Cerebral Palsy; ages 6-17 years old. The sample of 50 subjects (25 in each group) will be recruited in care centers for children and adolescents with Cerebral Palsy in Alcalá de Henares.
The outcome variables are: participation in the environment (Spanish version of the Children's Assessment of Participation and Enjoyment - CAPE), gait speed (10-meter walk test - 10MM), gait endurance (6-minute walk test - 6MM), gross motor function (Spanish version of the Gross Motor Function Measure - GMFM-SP) and static and dynamic balance (Spanish version of the Pediatric Balance Scale - PBS). They will be collected in three moments: baseline assessment (V0); intermediate assessment (V1) at 6 weeks at the end of each group intervention; Final assessment (V2) 3 months after baseline.
Detailed description
Group A Physical Therapy intervention group will receive 18 sessions, 3 times a week, for 6 consecutive weeks; on the one hand, 12 face-to-face sessions of approximately 90 minutes duration, in which the Physical Therapy treatment will be carried out based on training of specific tasks directed to objectives and training of gait with a treadmill; In addition, a therapeutic education program will be carried out, with 6 telehealth sessions, which will include action observation therapy. Subjects in Group B (control group) will receive their usual Physiotherapy intervention regimen for 6 weeks at their referral center and the same telehealth Therapeutic Education program of the intervention group. The face-to-face sessions of the intervention group will be carried out in the Physiotherapy Teaching Unit of the University of Alcalá, and the telehealth sessions of the Therapeutic Education program of both groups will be carried out by remote assistance through a digital platform. All will be carried out by specialist Physiotherapists, members of the research team.
Statistical Analysis: After assessments, the data will be analyzed to verify the results. It will be done: descriptive analysis of the sample (means, medians, standard deviations and quartiles; normality test; frequency distributions): homogeneity check of the groups (t-Student or Mann Withney's U - quantitative variables; Chi square or F of Fisher - categorical variables); effectiveness analysis (parametric tests or not of paired samples; multivariate models to adjust for possible confounding factors; multivariate model of repeated measures to evaluate the result of the intervention. The statistical package Statistical Package for the Social Sciences software (25 version , SPSS Inc, Chicago, USA) or the statistical package STATA MP v14.2 (StataCo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A_Intervention Group | Experimental | Other: Physical Therapy, Other: THERAPEUTIC EDUCATION PROGRAMIt will consist of 18 sessions, 3 times a week, for 6 consecutive weeks; on the one hand, 12 face-to-face sessions of approximately 90 minutes duration, in which the Physical Therapy treatment will be carried out based on training of specific tasks directed to objectives and training of gait with a treadmill; In addition, a therapeutic education program will be carried out, with 6 telehealth sessions lasting approximately 60 minutes, which will include action observation activities. The face-to-face sessions will be held at the Physical Therapy Teaching Unit at University of Alcalá, and the telehealth sessions of the Therapeutic Education program will be carried out by remote assistance through a digital platform. All will be carried out by specialist Physical Therapists, members of the research team. |
| Group B_Control Group | Experimental | Other: THERAPEUTIC EDUCATION PROGRAMThe subjects in this group will receive their usual Physical Therapy intervention regimen for 6 weeks at their referral center and the same telehealth Therapeutic Education program of the intervention group. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- GMFCS (I-III); MACS (I-III); CFCS (I-III)
Key exclusion criteria (1 listed)
- having undergone surgery on lower limbs in the 6 months prior to his participation in the study; having surgery during the study; inability to follow the planned program due to moving to other city or other reason.
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 |
|---|---|---|
| Physical TherapyAlso: Therapeutic Education, Family centered model, Action Observation Therapy, Goal-directed trainingFACE-TO FACE SESSIONS: approximately 90 minutes of Goal-directed training (activities for the activation of the muscles of the trunk, pelvis and lower limbs; and training of activities will be carried out in a functional and meaningful context, aimed at specific functional objectives, according to the interests of each participant and agreed with the participants and their families) and gait training on the treadmill for 20 minutes. TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation. | Other | Group A_Intervention Group |
| THERAPEUTIC EDUCATION PROGRAMTELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation. | Other | Group A_Intervention Group, Group B_Control Group |
Primary outcome
Change in baseline Environmental participation at 6 weeks and 3 months
Time frame: Baseline assessment
Spanish version of Children's Assessment of Participation and Enjoyment (CAPE)
Change in baseline Gait speed at 6 weeks and 3 months
Time frame: Baseline assessment
10 meter walk Test
Change in baseline Gait endurance at 6 weeks and 3 months
Time frame: Baseline assessment
6 minutes walk test
Change in baseline Gross Motor Function at 6 weeks and 3 months
Time frame: Baseline assessment
Spanish version of Gross Motor Function Measure (GMFM-SP)
Change in baseline Static and Dynamic Balance at 6 weeks and 3 months
Time frame: Baseline assessment
Spanish version of Pediatric Balance Scale (PBS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Results publication: PubMed 32086598Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
- Results publication: PubMed 31910452Sellier E, McIntyre S, Smithers-Sheedy H, Platt MJ; SCPE and ACPR Groups. European and Australian Cerebral Palsy Surveillance Networks Working Together for Collaborative Research. Neuropediatrics. 2020 Apr;51(2):105-112. doi: 10.1055/s-0039-3402003. Epub 2020 Jan 7.
- Results publication: PubMed 29845609Schiariti V, Mahdi S, Bolte S. International Classification of Functioning, Disability and Health Core Sets for cerebral palsy, autism spectrum disorder, and attention-deficit-hyperactivity disorder. Dev Med Child Neurol. 2018 Sep;60(9):933-941. doi: 10.1111/dmcn.13922. Epub 2018 May 30.
- Results publication: PubMed 31677546Chakraborty S, Nandy A, Kesar TM. Gait deficits and dynamic stability in children and adolescents with cerebral palsy: A systematic review and meta-analysis. Clin Biomech (Bristol). 2020 Jan;71:11-23. doi: 10.1016/j.clinbiomech.2019.09.005. Epub 2019 Oct 18.
- Results publication: PubMed 29637118Toovey R, Bernie C, Harvey AR, McGinley JL, Spittle AJ. Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review. BMJ Paediatr Open. 2017 Aug 11;1(1):e000078. doi: 10.1136/bmjpo-2017-000078. eCollection 2017.
- Results publication: PubMed 32161730Han YG, Yun CK. Effectiveness of treadmill training on gait function in children with cerebral palsy: meta-analysis. J Exerc Rehabil. 2020 Feb 26;16(1):10-19. doi: 10.12965/jer.1938748.374. eCollection 2020 Feb.
- Derived from this study: PubMed 40217665Pacheco-da-Costa S, Rodriguez-Costa I, Abuin-Porras V, Asunsolo-Del-Barco A, Calvo-Fuente V, Soto-Vidal C. Effectiveness of Physiotherapy for Improving Participation, Gross Motor Function, Gait and Balance in Children and Adolescents with Cerebral Palsy: Study Protocol for a Randomized Controlled Trial. J Clin Med. 2025 Mar 24;14(7):2214. doi: 10.3390/jcm14072214.
- 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.
Soraya Pacheco da Costa, PhD principal investigator
University Professor Physical Therapy Degree
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and THERAPEUTIC EDUCATION PROGRAM in people with Physical Therapy and Cerebral Palsy, run by University of Alcala at 1 site 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 1 inclusion and 1 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 9 Feb 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 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?
Contact Soraya Pacheco da Costa, PhD (661855923, soraya.pacheco@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline Environmental participation at 6 weeks and 3 months (time frame: Baseline assessment). The study lists 5 primary outcomes in all. 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 NCT04778930, 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 9 Feb 2023.