Physical Therapy for Improving Functionality, Gait and Participation in Cerebral Palsy
NCT ID: NCT04778930
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
66 participants
INTERVENTIONAL
2022-02-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
NCT03521427
Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study
NCT05608954
Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy
NCT06314776
Evidence-based Physical Therapy in Children With Cerebral Palsy
NCT02193386
A Physical Therapy Program Targeting Lower Extremity Selective Motor Control in Children With Spastic Cerebral Palsy
NCT07310550
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A_Intervention Group
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.
Physical Therapy
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 PROGRAM
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.
Group B_Control Group
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.
THERAPEUTIC EDUCATION PROGRAM
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Physical Therapy
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 PROGRAM
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alcala
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Soraya Pacheco da Costa
University Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Soraya Pacheco da Costa, PhD
Role: PRINCIPAL_INVESTIGATOR
University Professor Physical Therapy Degree
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Physiotherapy Neuromusculoskeletal in life stages Research Group - FINEMEV
Alcalá de Henares, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sellier 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.
Schiariti 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.
Chakraborty 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.
Toovey 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.
Han 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.
Pacheco-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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCosta
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.