None listed
Conditions
Brief summary
This trial is investigating whether a new physiotherapy device used in children with cystic fibrosis meets the needs of clients better than the current technology and thus is used more often and effectively used than the standard device. Cystic fibrosis is a genetic condition associated with significant lung disease. Chest physiotherapy helps move infected secretions out the lung and is a standard part of daily therapy. However, adherence with this therapy is low for many reasons. This device has been designed to address many of these problems and hopefully will improve adherence. The type of physiotherapy being addressed in thus study is call PEP (which stands for positive expiratory pressure) and would be well known to patients and those involve in patient care. The prototype device measures the pressure produced during each blow. The active device connects wirelessly to a tablet computer. Each blow is displayed on the screen. There are features including a game controlled by the blows, an alarm function, points which are earned with each correct blow which can be redeemed and the capacity to download adherence data at clinical reviews. Subjects will be randomly allocated to use either the new device or a control device which measures adherence but otherwise looks the same as a normal device for 6 weeks. Subjects will be aged 4-16 years. The main outcome will be adherence with the device. Those who don't get to use the device in the first 6 weeks will get to use it during a second 6 week period.
Interventions
The PEP Personal Trainer is a newly developed device which has been designed to provide both PEP (positive end expiratory pressure) chest physiotherapy and some key additional functions. A PEP mask is held to the face by the user. The user inhales gently through the mask and then exhales against resistance because of a one way valve and resistor. This provides pressure back down their airway. It is suggested that the subject reach and maintain 10-20cm water pressure for 3 seconds. This is a stan
The PEP Personal Trainer is a newly developed device which has been designed to provide both PEP (positive end expiratory pressure) chest physiotherapy and some key additional functions. A PEP mask is held to the face by the user. The user inhales gently through the mask and then exhales against resistance because of a one way valve and resistor. This provides pressure back down their airway. It is suggested that the subject reach and maintain 10-20cm water pressure for 3 seconds. This is a standard and well proven form of chest physiotherapy. During a session a user will normal perform 100 exhalations. The PEP PT measures the pressure associated with each blow using a electronic sensor contained within the mask. The PEP PT connects wirelessly to a tablet device. The key features of the device include: 1. An alarm to remind the subject to perform their PEP (typically done twice daily), 2. The screen displays the ideal pressure curve which the subject can follow to ensure an ideal technique, 3. The subject can play games on the device which again require and encourage an ideal technique (for example piloting a space ships which collects asteroids), 4. The device counts the number of blows performed and provides prompts and encouragement, 5. The devices scores each blow and assigns a point for each effective blow (PEP points) which the child's parent can redeem for rewards, 6. The device stores information about both adherence and technique which can be reviewed at consultations. In this trial subjects will be randomised to either the PEP PT or a control device which measures adherence and technique but does not connect to a screen or have the other features. The subjects use either device for 6 weeks. Subjects assigned to the control device then use the PEP PT for six weeks (wait list control method).
Sponsors
Mater Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Cystic Fibrosis, using PEP and currently well.
Exclusion criteria
FEV1 less than 40% predicted
Outcome results
None listed