NCT04778930: FIMAPACE

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

Status unknown NA Last updated 9 February 2023

What this trial tests

NA trial testing Physical Therapy in Physical Therapy in 66 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
30 January 2023

31 December 2023

Quick facts

Lead sponsor	University of Alcala
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	66
Start date	1 February 2022
Primary completion	30 January 2023
Estimated completion	31 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• Physical Therapy
• THERAPEUTIC EDUCATION PROGRAM

Conditions studied

• Physical Therapy — all drugs for Physical Therapy →
• Cerebral Palsy — all drugs for Cerebral Palsy →
• Therapeutic Education — all drugs for Therapeutic Education →
• Telehealth — all drugs for Telehealth →

Sponsor

University of Alcala

Who can join

Adults 6 to 17, any sex, with Physical Therapy or Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of a Telecare Physical Therapy Program in Improving Functionality in Children and Adolescents with Cerebral Palsy: A Cases Study.
   Rodríguez-Costa I, Abuín-Porras V, Terán-García P, Férez-Sopeña A, et al · · 2023 · cited 3× · PMID 37189912 · DOI 10.3390/children10040663
2. 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.
   Pacheco-da-Costa S, Rodríguez-Costa I, Abuín-Porras V, Asúnsolo-Del-Barco Á, et al · · 2025 · PMID 40217665 · DOI 10.3390/jcm14072214