Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital respiratory intervention program.
- Who it may be relevant to
- Registry conditions: Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Muscular Dystrophy. Basic parameters: 5 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy.
Overview
The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy.
Detailed description
It will be done 4 times a week for a period of 5 weeks, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. An intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery.
It is advisable during intervention program to have a playful environment stimulated for the children, and that the intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as with a weekly follow-up using WhatsApp as forms of communication, or a telephone call to ensure correct follow-up of the intervention program.
It is essential that to carry out the intervention, videos obtained from YouTube, own videos prepared to explain the exercises in a playful way applied to children, and even other applications such as Spotify to work with music, will be used, being offered in case of Zoom calls may be necessary to help optimally resolve doubts that arise when carrying out the program by video call.
At the end of the respiratory digital physiotherapy program, variables will be evaluated by the principal examiner.
Interventions
- Other Digital respiratory intervention program
A 4 times a week for a period of 5 weeks will be done, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. Moreover, an intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery. The intervention program is carried out and stimulated t
Primary outcome measures
- Analyze the improvement of the forced vital capacity (FVC). [Time frame: Baseline, up to 5 weeks.]
Secondary outcome measures (10)
- Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination. [Time frame: Baseline, up to 5 weeks.]
- Perform an anthropometric study of the patient's characteristics, taking into account age. [Time frame: Baseline, up to 5 weeks.]
- Perform an anthropometric study of the patient's characteristics, taking into account height. [Time frame: Baseline, up to 5 weeks.]
- Perform an anthropometric study of the patient's characteristics, taking into account sex. [Time frame: Baseline, up to 5 weeks.]
- Examine changes in forced expiratory pressure [Time frame: Baseline, up to 5 weeks.]
- Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). [Time frame: Baseline, up to 5 weeks.]
- Check if there are changes in the sniff nasal inspiratory pressure (SNIP) [Time frame: Baseline, up to 5 weeks.]
- Evaluate the fatigue in patients using an EPInfant test. [Time frame: Baseline, up to 5 weeks.]
- Evaluate the quality of life of patients using a scale called "Kindscreen-52". [Time frame: Baseline, up to 5 weeks.]
- North Star Ambulatory Assessment o NSAA [Time frame: Baseline, up to 5 weeks.]
Eligibility criteria
Inclusion criteria
- Participants with Duchenne muscular dystrophy and patients with Becker muscular dystrophy will be chosen.
- Aged between 5 and 20 years.
- Child who could walk and follow the intervention program, and were diagnosed according to the International Classification of Diseases, 10 Revision. code (G71-01); and who had an NSSA score greater than 20.
Exclusion criteria
- Patients who present associated heart disease.
- Patients who presentor fractures, a heart rate greater than 120 beats per minute, or an oxygen saturation less than 89% will be excluded.
- Participants who do not have the capacity to have internet at home to perform the intervention, as well as all patients whose caregivers did not agree to sign the informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Rocío Martín-Valero — Málaga
Identifiers
NCT: NCT06363526 · UMalagaDRIP