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Physical Therapy for Improving Functionality, Gait and Participation in Cerebral Palsy

Effectiveness of Physical Therapy for Improving the Functionality, Gait and Participation in the Environment in Children and Adolescents With Cerebral Palsy: Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04778930
Acronym
FIMAPACE
Enrollment
66
Registered
2021-03-03
Start date
2022-02-01
Completion date
2023-12-31
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Physical Therapy, Telehealth, Therapeutic Education

Keywords

Physical Therapy, Cerebral Palsy, Telehealth, Therapeutic Education

Brief 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. 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)

Interventions

OTHERPhysical 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.

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.

Sponsors

University of Alcala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

As masking techniques, the persons responsible for the assessment of the subjects and the data collection, the random assignment and the intervention in each group will be independent from each other.

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* GMFCS (I-III); MACS (I-III); CFCS (I-III)

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in baseline Environmental participation at 6 weeks and 3 monthsBaseline assessmentSpanish version of Children's Assessment of Participation and Enjoyment (CAPE)
Change in baseline Gait speed at 6 weeks and 3 monthsBaseline assessment10 meter walk Test
Change in baseline Gait endurance at 6 weeks and 3 monthsBaseline assessment6 minutes walk test
Change in baseline Gross Motor Function at 6 weeks and 3 monthsBaseline assessmentSpanish version of Gross Motor Function Measure (GMFM-SP)
Change in baseline Static and Dynamic Balance at 6 weeks and 3 monthsBaseline assessmentSpanish version of Pediatric Balance Scale (PBS)

Countries

Spain

Contacts

Primary ContactSoraya Pacheco da Costa, PhD
soraya.pacheco@uah.es661855923
Backup ContactConcepción Soto Vidal, PhD
conchi.soto@uah.es918854838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026