Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies

Study Overview
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Brief Summary
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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.

Official Title
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Effects of the Physical Therapy Treatment on Children and Adolescents With Chronic and Neurological Pathologies Affecting Their Sensorimotor Abilities.

Conditions
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Duchenne, Neurologic Disorder, Pediatric Disorder, Sensorimotor Disorder Nos

Intervention / Treatment
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* Other: Home-based physiotherapy
* Other: Usual Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based Physiotherapy<br>Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) + 3 hours extra of home-based physiotherapy (stretching, active mobilizations) | Other: Home-based physiotherapy<br>* Manual Therapy, passive and active mobilizations, stretching, respiratory techniques<br>|
| Active Comparator: Usual physiotherapy<br>Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) | Other: Usual Physiotherapy<br>* Usual care provided for the management of neurological disorders in children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Function Measure | Measurement scale for motor function applied to neuromuscular diseases (MFM): It was created in France in order to perform a better evaluation of global motor function in patients with Duchenne's muscular dystrophy (DMD), both for ambulatory and non-ambulatory patients. It has two versions, MFM 20 for children under 6 years of age and MFM 32 for children over 6 years of age. The scale considers three dimensions: (D1) standing station and transfers; (D2) axial and proximal motor skills and (D3) distal motor skills. The sum of the three results in a global percentage that provides an updated overview of the patient's functional diagnosis. (Trundell et al., 2020) | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vignos Scale | It is a functional classification that scores from 1 to 10, where the highest number represents the most intense progressive condition of DMD reflected in the patient's ambulation. The possible categories are: (1) walks and climbs stairs without assistance (2) walks and climbs stairs with assistance or handrails (3) walks and climbs stairs slowly with the assistance of handrails (4) walks without assistance and gets up from a chair but does not climb stairs (5) walks without assistance but cannot get up from a chair or climb stairs (6) walks only with the aid of long orthoses (7) walks with long orthoses but needs help to maintain balance (8) stands upright with orthoses but unable to walk or with assistance, (9) in a wheelchair and (10) confined to bed.(Fernandes et al., 2014; Martini et al., 2015) | One Year | 
| Timed Up and Go Test | Determines the patient's risk of falling. The test is performed under a stopwatch, asking the patient to get up from a chair (with or without support), stand up, walk 3 meters, turn around and come back to sit on the chair again. If the patient takes more than 20 seconds to perform, they have a high risk of falling; and between 10 and 20 seconds will indicate fragility. (Alkan et al., 2017) | One Year | 
| Six Minutes Walk Distance | It consists of quantifying in meters the distance traveled in 6 minutes by the patient. The more meters walked, the less impairment.(Mcdonald et al., 2013) Individualized periodic assessment of 6 Minutes Walking Distance (6MWD) is the most widely accepted primary clinical endpoint in Duchenne's muscular dystrophy (DMD) clinical trials(Goemans et al., 2016); and provides a better prognosis than those based solely on age. After analyzing its test-retest reliability in DMD, its ICC is 0.92. (Mcdonald et al., 2013) | One Year | 
| Brooke Upper Extremity Scale | It is a scale of levels from 1 to 5 for the motor functional classification of the upper limbs. (Brooke et al., 1989) It is graded according to the motor ability of the child evaluated in the following categories: (1) bring the arms towards the ceiling (2) raises arms above head but bends elbows (3) cannot raise hands above head, but can bring glass of water to mouth (4) holds pen or picks up coin and ( 5) It does not have any useful function with the hand. The lower the score, the better the upper extremity motor function. (Mayhew et al., 2013) In addition, this scale is frequently used in the DMD population and its intraclass correlation coefficient (ICC) is .99 .(Lue et al., 2006) | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood, Neurologic disorder, Duchenne