Clinical trial NCT05313295: Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies
Official title: Effects of the Physical Therapy Treatment on Children and Adolescents With Chronic and Neurological Pathologies Affecting Their Sensorimotor Abilities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Disorder
Duchenne
Pediatric Disorder
Sensorimotor Disorder Nos
Keywords: Childhood
Neurologic disorder
Duchenne
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment.


Eligibility criteria: Inclusion Criteria:

* Parents agree to include their children on the study
* Affiliated to the Duchenne Parents Project Association (Spain)
* Between 3-18 years old

Exclusion Criteria:

* Other pathological conditions
* Parents refuse the participation on the study

Primary outcomes:
measure: Motor Function Measure
timeFrame: One Year
Secondary outcomes:
measure: Brooke Upper Extremity Scale
timeFrame: One Year
measure: Vignos Scale
timeFrame: One Year
measure: Timed Up and Go Test
timeFrame: One Year
measure: Six Minutes Walk Distance
timeFrame: One Year
Other outcomes:
Locations:
city: Almería
country: Spain
facility: María del Mar Sánchez-Joya
Study officials:
affiliation: Universidad de Almeria
name: María del Mar Sánchez-Joya, PhD
role: STUDY_CHAIR
References:
citation: Alemdaroglu I, Karaduman A, Yilmaz OT, Topaloglu H. Different types of upper extremity exercise training in Duchenne muscular dystrophy: effects on functional performance, strength, endurance, and ambulation. Muscle Nerve. 2015 May;51(5):697-705. doi: 10.1002/mus.24451. Epub 2015 Mar 5.
citation: Alkan H, Mutlu A, Firat T, Bulut N, Karaduman AA, Yilmaz OT. Effects of functional level on balance in children with Duchenne Muscular Dystrophy. Eur J Paediatr Neurol. 2017 Jul;21(4):635-638. doi: 10.1016/j.ejpn.2017.02.005. Epub 2017 Feb 20.
citation: Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E, Epps H, Main M, Geary M, McMurchie H, Pallant L, Woods D, Freeman J, Lee E, Eagle M, Willis T, Muntoni F, Baxter P. Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation. Health Technol Assess. 2017 May;21(27):1-120. doi: 10.3310/hta21270.
citation: Goemans N, Vanden Hauwe M, Signorovitch J, Swallow E, Song J; Collaborative Trajectory Analysis Project (cTAP). Individualized Prediction of Changes in 6-Minute Walk Distance for Patients with Duchenne Muscular Dystrophy. PLoS One. 2016 Oct 13;11(10):e0164684. doi: 10.1371/journal.pone.0164684. eCollection 2016.
citation: Jansen M, van Alfen N, Geurts AC, de Groot IJ. Assisted bicycle training delays functional deterioration in boys with Duchenne muscular dystrophy: the randomized controlled trial "no use is disuse". Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):816-27. doi: 10.1177/1545968313496326. Epub 2013 Jul 24.