Physical Therapy for Improving Functionality, Gait and Participation in Cerebral Palsy (FIMAPACE)
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Soraya Pacheco da Costa, PhD
- Phone Number: 661855923
- Email: soraya.pacheco@uah.es
Study Contact Backup
- Name: Concepción Soto Vidal, PhD
- Phone Number: 918854838
- Email: conchi.soto@uah.es
Study Locations
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Madrid
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Alcalá de Henares, Madrid, Spain, 28005
- Recruiting
- Physiotherapy Neuromusculoskeletal in life stages Research Group - FINEMEV
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Contact:
- Soraya Pacheco da Costa
- Phone Number: 661855923
- Email: soraya.pacheco@uah.es
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 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.
|
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.
Other Names:
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.
|
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EXPERIMENTAL: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline Environmental participation at 6 weeks and 3 months
Time Frame: Baseline assessment
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Spanish version of Children's Assessment of Participation and Enjoyment (CAPE)
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Baseline assessment
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Change in baseline Gait speed at 6 weeks and 3 months
Time Frame: Baseline assessment
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10 meter walk Test
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Baseline assessment
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Change in baseline Gait endurance at 6 weeks and 3 months
Time Frame: Baseline assessment
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6 minutes walk test
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Baseline assessment
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Change in baseline Gross Motor Function at 6 weeks and 3 months
Time Frame: Baseline assessment
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Spanish version of Gross Motor Function Measure (GMFM-SP)
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Baseline assessment
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Change in baseline Static and Dynamic Balance at 6 weeks and 3 months
Time Frame: Baseline assessment
|
Spanish version of Pediatric Balance Scale (PBS)
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Baseline assessment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soraya Pacheco da Costa, PhD, University Professor Physical Therapy Degree
Publications and helpful links
General 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.
- 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, Avon). 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCosta
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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