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Clinical Trials/NCT05313295
NCT05313295CompletedNot Applicable

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

Universidad de Almeria1 site in 1 country30 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Motor Function Measure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
3 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Home-based Physiotherapy

Experimental

Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) + 3 hours extra of home-based physiotherapy (stretching, active mobilizations)

Intervention: Home-based physiotherapy (Other)

Usual physiotherapy

Active Comparator

Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques)

Intervention: Usual Physiotherapy (Other)

Outcomes

Primary Outcomes

Motor Function Measure

Time Frame: One Year

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)

Secondary Outcomes

  • Brooke Upper Extremity Scale(One Year)
  • Vignos Scale(One Year)
  • Timed Up and Go Test(One Year)
  • Six Minutes Walk Distance(One Year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

María del Mar Sánchez Joya

Associate Professor

Universidad de Almeria

Study Sites (1)

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