Cystic Fibrosis in ChildrenPPCNCT04835376
Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis
A study testing Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis in people with Cystic Fibrosis in Children, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
Cystic Fibrosis is the most prevalent fatal genetic disease affecting Canadian children and it primarily characterized by a thickening of pulmonary secretions and impaired mucociliary clearance. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children with CF under the age of 6 and their parent/guardian/caregiver to perform chest percussions using percussor palm cups.
- Participants must currently require regular chest physiotherapy.
Who cannot join
- A comorbid condition that is a contraindication for the use of percussor palm cups.
- Inability of parent/guardian/caregiver to complete written questionnaires due to visual or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Children's Hospital Cystic Fibrosis Clinic
Hamilton, Ontario, L8S 2A5
About this study
Official title: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children With Cystic Fibrosis
Cystic Fibrosis is the most prevalent fatal genetic disease affecting Canadian children and it primarily characterized by a thickening of pulmonary secretions and impaired mucociliary clearance. Chest physiotherapy has been widely used as a standard treatment for sputum mobilization and clearance for individuals with CF. Percussion is one such technique of chest physiotherapy for loosening trapped music within the lungs and can be completed manually or facilitated with a percussion cup. Unfortunately, the exclusive Canadian supplier for the widely use percussor cup has stopped distributing the cups, leaving many hospitals and therapy clinics searching for alternatives to continue airway clearance treatment. The goal of this project is to compare alternative palm cup solutions to the standard, and recommend safe alternative(s) that caregivers can have easy access to.
Read the detailed description
An average adult hand may be too large and taxing for percussion on infants and children, therefore percussor palm cups facilitate caregivers and physiotherapists. The palm cup mimics the air compressed through cupped hands and can be used in conjunction with other physiotherapy techniques and has been shown to have a positive impact on symptoms. Engineers at McMaster University have developed 3D-printed prototypes to use with percussor cups that are made with material similar in consistency and flexibility to the no longer manufactured, standard cup. These cups will be tested in infants and children with cystic fibrosis recruited from the Cystic Fibrosis Clinic at McMaster Children's Hospital in Hamilton, Ontario.
Patients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days (one standard cup and two 3D-printed). Each cup will be trialed for 2 days, allowing for equal time dedicated to each. Demographic data and characteristics will be collected at baseline, and measures of safety and usability will be completed at the end of the week of use. Overall satisfaction will be recorded at the end of the questionnaire. Participants will be asked to rate percussion palm cups from least preferred to most preferred and an open-ended question to explain their reasoning on the experience.
Thus, the purpose of the study is to examine the safety, usability and user experience of newly designed percussion palm cups using 3-D printing. The results of this study will have important implication to the management of infants and children with CF given the percussion palm cup shortage.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Chest Physiotherapy, Percussion Palm Cup, Children and Infants
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic FibrosisDevice
Patients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days. Each cup will be trialed for 2 days, allowing for equal time dedicated to each.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 1 | Experimental | The standard percussor palm cups are made out of a soft vinyl material molded into shape. The outer diameter of the infant palm cup is 1-3/4 inches and there is a 1-inch diameter pocket inside this product similar to a suction cup. Receives: Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis |
| Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 2 | Experimental | This product was developed by MMRI personnel using a small custom 3D printed plastic handle and a 0.93-inch, single bellow, Buna-N rubber suction cup. The handle was made on the MMRI's 3D printer using ABS plastic and the suction cup was sourced from McMaster Carr (#5427A106). The handle is made up of three pieces; top, base and a pin that is designed to fix the top, base and suction cup to each other. There is a small hole through the pin which helps relieve some of the pressure that builds in the suction cup during use. It is not shown in the image to the right, but the handle will be coated in Plasti Dip for added user comfort. Receives: Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis |
| Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 3 | Experimental | This product was developed by MMRI personnel using a large custom 3D printed plastic handle and a 0.93-inch, single bellow, Buna-N rubber suction cup. The handle was made on the MMRI's 3D printer using ABS plastic and the suction cup was sourced from McMaster Carr (#5427A106). The handle is made up of three pieces; top, base and a pin that is designed to fix the top, base and suction cup to each other. There is a small hole through the pin which helps relieve some of the pressure that builds in the suction cup during use. It is not shown in the image to the right, but the handle will be coated in Plasti Dip for added user comfort. Receives: Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and user questionnaire
Participants and families will be asked to report any adverse effects of the use of the PCC. These could include erythema of the skin, bruising or general discomfort using a 5-point Likert scale (1 = very disatisfied, 5 = very satisfied) and open-ended questions. A higher value on the Likert scale indicates a better outcome as the participant identifies that they were satisfied when using the cup. This will also be used to compare satisfaction between cups.
Measured: Through study completion, average 1 year
Usability using the Pictorial Single-Item Usability Scale (PSIUS)
The Pictorial Single-Item Usability Scale (PSIUS) is an instrument used to measure perceived usability and satisfaction of each cup. This scale concludes three main visual elements that evaluate satisfaction and emotions experience while using a system or product. It uses visual images of disatisfaction to satisfaction, following a 9-point scale (-4 = very disatisfied, 4 = very satisfied). A higher number indicates a better experience when using the cup. This pictorial single-item scale will be used within our questionnaire to assess the overall rating of satisfaction and usability when using the Percussion Palm Cups.
Measured: Through study completion, average 1 year
Secondary outcomes (2)
Quebec User Evaluation Utility Questionnaire (QUEST)
The Quebec User Evaluation Utility Questionnaire (QUEST) is designed to evaluate user satisfaction and dissatisfaction with assistive devices. It is the most commonly used standardized instrument for measuring user satisfaction with a broad range of assistive technology devices. The revised QUEST 2.0 version includes a 12-item structure, with each item scored using a 5-point satisfaction scale (1= not satisfied at all, 5 = very satisfied). Additionally, the user is asked to comment on the source of their dissatisfaction or satisfaction on each item. We will use the applicable items (8 in total) Comfort, Dimensions, Simplicity of Use, Effectiveness, Durability, Adjustments, Safety, and Weight.
Measured: Through study completion, average 1 year
Overall satisfaction questionnaire
Overall satisfaction and user experience will be recorded. Participants will be asked to discuss any concerns, discomfort when using the palm cup and rate percussion palm cups from least preferred to most preferred with open-ended questions to explain their reasoning with no minimum or maximum values. Each cup will be ranked as either first, second, and third choice (cup #1,2,3 = first, second or third choice in ranking). First choice indicates the best overall experience, last choice indicates the worst overall expereince or least preferred.
Measured: Through study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Brooks, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835376
- Sponsor's protocol ID
- 13112
- Acronym
- PPC
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Button BM, Heine RG, Catto-Smith AG, Olinsky A, Phelan PD, Ditchfield MR, Story I. Chest physiotherapy in infants with cystic fibrosis: to tip or not? A five-year study. Pediatr Pulmonol. 2003 Mar;35(3):208-13. doi: 10.1002/ppul.10227.
PubMed 12567389Flume PA, Robinson KA, O'Sullivan BP, Finder JD, Vender RL, Willey-Courand DB, White TB, Marshall BC; Clinical Practice Guidelines for Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care. 2009 Apr;54(4):522-37.
PubMed 19327189Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066-73. doi: 10.1126/science.2475911.
PubMed 2475911Collins FS. Cystic fibrosis: molecular biology and therapeutic implications. Science. 1992 May 8;256(5058):774-9. doi: 10.1126/science.1375392.
PubMed 1375392Gursli S, Sandvik L, Bakkeheim E, Skrede B, Stuge B. Evaluation of a novel technique in airway clearance therapy - Specific Cough Technique (SCT) in cystic fibrosis: A pilot study of a series of N-of-1 randomised controlled trials. SAGE Open Med. 2017 Mar 17;5:2050312117697505. doi: 10.1177/2050312117697505. eCollection 2017.
PubMed 28540046O'Sullivan BP, Freedman SD. Cystic fibrosis. Lancet. 2009 May 30;373(9678):1891-904. doi: 10.1016/S0140-6736(09)60327-5. Epub 2009 May 4.
PubMed 19403164Orenstein DM, Boat TF, Stern RC, Tucker AS, Charnock EL, Matthews LW, Doershuk CF. The effect of early diagnosis and treatment in cystic fibrosis: a seven-year study of 16 sibling pairs. Am J Dis Child. 1977 Sep;131(9):973-5. doi: 10.1001/archpedi.1977.02120220039005.
PubMed 900085Warnock L, Gates A. Chest physiotherapy compared to no chest physiotherapy for cystic fibrosis. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD001401. doi: 10.1002/14651858.CD001401.pub3.
PubMed 26688006Punithavathi N, Ong LM, Irfhan Ali HA, Mohd Izmi IA, Dharminy T, Ang AH, Hadzlinda Z, Sivasangari S. A Pilot Randomized Control Cross over Study Evaluating the Effectiveness and Safety of Mechanical Percussor Compared with Conventional Chest Physiotherapy in Adults with Productive Cough. Med J Malaysia. 2014 Feb;69(1):16-20.
PubMed 24814623Blazey S, Jenkins S, Smith R. Rate and force of application of manual chest percussion by physiotherapists. Aust J Physiother. 1998;44(4):257-264. doi: 10.1016/s0004-9514(14)60385-8.
PubMed 11676741Gregson RK, Stocks J, Petley GW, Shannon H, Warner JO, Jagannathan R, Main E. Simultaneous measurement of force and respiratory profiles during chest physiotherapy in ventilated children. Physiol Meas. 2007 Sep;28(9):1017-28. doi: 10.1088/0967-3334/28/9/004. Epub 2007 Aug 21.
PubMed 17827650Hardy KA, Anderson BD. Noninvasive clearance of airway secretions. Respir Care Clin N Am. 1996 Jun;2(2):323-45.
PubMed 9390886Demers L, Weiss-Lambrou R, Ska B. Item analysis of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). Assist Technol. 2000;12(2):96-105. doi: 10.1080/10400435.2000.10132015.
PubMed 11508406Greulich T, Kehr K, Nell C, Koepke J, Haid D, Koehler U, Koehler K, Filipovic S, Kenn K, Vogelmeier C, Koczulla AR. A randomized clinical trial to assess the influence of a three months training program (gym-based individualized vs. calisthenics-based non-invidualized) in COPD-patients. Respir Res. 2014 Mar 25;15(1):36. doi: 10.1186/1465-9921-15-36.
PubMed 24666558Vaismoradi M, Turunen H, Bondas T. Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study. Nurs Health Sci. 2013 Sep;15(3):398-405. doi: 10.1111/nhs.12048. Epub 2013 Mar 11.
PubMed 23480423
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04835376
- Acronym / sponsor ID
- PPC / 13112
- Conditions
- Cystic Fibrosis in Children
- Keywords
- Cystic Fibrosis, Chest Physiotherapy, Percussion Palm Cup, Children and Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic Fibrosis is the most prevalent fatal genetic disease affecting Canadian children and it primarily characterized by a thickening of pulmonary secretions and impaired mucociliary clearance. Chest physiotherapy has been widely used as a standard treatment for sputum mobilization and clearance for individuals with CF. Percussion is one such technique of chest physiotherapy for loosening trapped music within the lungs and can be completed manually or facilitated with a percussion cup. Unfortunately, the exclusive Canadian supplier for the widely use percussor cup has stopped distributing the cups, leaving many hospitals and therapy clinics searching for alternatives to continue airway clearance treatment. The goal of this project is to compare alternative palm cup solutions to the standard, and recommend safe alternative(s) that caregivers can have easy access to.
Detailed description
An average adult hand may be too large and taxing for percussion on infants and children, therefore percussor palm cups facilitate caregivers and physiotherapists. The palm cup mimics the air compressed through cupped hands and can be used in conjunction with other physiotherapy techniques and has been shown to have a positive impact on symptoms. Engineers at McMaster University have developed 3D-printed prototypes to use with percussor cups that are made with material similar in consistency and flexibility to the no longer manufactured, standard cup. These cups will be tested in infants and children with cystic fibrosis recruited from the Cystic Fibrosis Clinic at McMaster Children's Hospital in Hamilton, Ontario.
Patients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days (one standard cup and two 3D-printed). Each cup will be trialed for 2 days, allowing for equal time dedicated to each. Demographic data and characteristics will be collected at baseline, and measures of safety and usability will be completed at the end of the week of use. Overall satisfaction will be recorded at the end of the questionnaire. Participants will be asked to rate percussion palm cups from least preferred to most preferred and an open-ended question to explain their reasoning on the experience.
Thus, the purpose of the study is to examine the safety, usability and user experience of newly designed percussion palm cups using 3-D printing. The results of this study will have important implication to the management of infants and children with CF given the percussion palm cup shortage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized crossover intervention
| Arm | Type | Receives |
|---|---|---|
| Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 1 | Experimental | Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic FibrosisThe standard percussor palm cups are made out of a soft vinyl material molded into shape. The outer diameter of the infant palm cup is 1-3/4 inches and there is a 1-inch diameter pocket inside this product similar to a suction cup. |
| Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 2 | Experimental | Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic FibrosisThis product was developed by MMRI personnel using a small custom 3D printed plastic handle and a 0.93-inch, single bellow, Buna-N rubber suction cup. The handle was made on the MMRI's 3D printer using ABS plastic and the suction cup was sourced from McMaster Carr (#5427A106). The handle is made up of three pieces; top, base and a pin that is designed to fix the top, base and suction cup to each other. There is a small hole through the pin which helps relieve some of the pressure that builds in the suction cup during use. It is not shown in the image to the right, but the handle will be coated in Plasti Dip for added user comfort. |
| Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 3 | Experimental | Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic FibrosisThis product was developed by MMRI personnel using a large custom 3D printed plastic handle and a 0.93-inch, single bellow, Buna-N rubber suction cup. The handle was made on the MMRI's 3D printer using ABS plastic and the suction cup was sourced from McMaster Carr (#5427A106). The handle is made up of three pieces; top, base and a pin that is designed to fix the top, base and suction cup to each other. There is a small hole through the pin which helps relieve some of the pressure that builds in the suction cup during use. It is not shown in the image to the right, but the handle will be coated in Plasti Dip for added user comfort. |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants and children with CF under the age of 6 and their parent/guardian/caregiver to perform chest percussions using percussor palm cups.
- Participants must currently require regular chest physiotherapy.
Key exclusion criteria (2 listed)
- A comorbid condition that is a contraindication for the use of percussor palm cups.
- Inability of parent/guardian/caregiver to complete written questionnaires due to visual or cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic FibrosisPatients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days. Each cup will be trialed for 2 days, allowing for equal time dedicated to each. | Device | Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 1, Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 2, Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 3 |
Primary outcome
Safety and user questionnaire
Time frame: Through study completion, average 1 year
Participants and families will be asked to report any adverse effects of the use of the PCC. These could include erythema of the skin, bruising or general discomfort using a 5-point Likert scale (1 = very disatisfied, 5 = very satisfied) and open-ended questions. A higher value on the Likert scale indicates a better outcome as the participant identifies that they were satisfied when using the cup. This will also be used to compare satisfaction between cups.
Usability using the Pictorial Single-Item Usability Scale (PSIUS)
Time frame: Through study completion, average 1 year
The Pictorial Single-Item Usability Scale (PSIUS) is an instrument used to measure perceived usability and satisfaction of each cup. This scale concludes three main visual elements that evaluate satisfaction and emotions experience while using a system or product. It uses visual images of disatisfaction to satisfaction, following a 9-point scale (-4 = very disatisfied, 4 = very satisfied). A higher number indicates a better experience when using the cup. This pictorial single-item scale will be used within our questionnaire to assess the overall rating of satisfaction and usability when using the Percussion Palm Cups.
2 secondary outcomes
Quebec User Evaluation Utility Questionnaire (QUEST)
Time frame: Through study completion, average 1 year
Overall satisfaction questionnaire
Time frame: Through study completion, average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 12567389Button BM, Heine RG, Catto-Smith AG, Olinsky A, Phelan PD, Ditchfield MR, Story I. Chest physiotherapy in infants with cystic fibrosis: to tip or not? A five-year study. Pediatr Pulmonol. 2003 Mar;35(3):208-13. doi: 10.1002/ppul.10227.
- Background: PubMed 19327189Flume PA, Robinson KA, O'Sullivan BP, Finder JD, Vender RL, Willey-Courand DB, White TB, Marshall BC; Clinical Practice Guidelines for Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care. 2009 Apr;54(4):522-37.
- Background: PubMed 2475911Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066-73. doi: 10.1126/science.2475911.
- Background: PubMed 1375392Collins FS. Cystic fibrosis: molecular biology and therapeutic implications. Science. 1992 May 8;256(5058):774-9. doi: 10.1126/science.1375392.
- Background: PubMed 28540046Gursli S, Sandvik L, Bakkeheim E, Skrede B, Stuge B. Evaluation of a novel technique in airway clearance therapy - Specific Cough Technique (SCT) in cystic fibrosis: A pilot study of a series of N-of-1 randomised controlled trials. SAGE Open Med. 2017 Mar 17;5:2050312117697505. doi: 10.1177/2050312117697505. eCollection 2017.
- Background: PubMed 19403164O'Sullivan BP, Freedman SD. Cystic fibrosis. Lancet. 2009 May 30;373(9678):1891-904. doi: 10.1016/S0140-6736(09)60327-5. Epub 2009 May 4.
- Background: PubMed 900085Orenstein DM, Boat TF, Stern RC, Tucker AS, Charnock EL, Matthews LW, Doershuk CF. The effect of early diagnosis and treatment in cystic fibrosis: a seven-year study of 16 sibling pairs. Am J Dis Child. 1977 Sep;131(9):973-5. doi: 10.1001/archpedi.1977.02120220039005.
- Background: PubMed 26688006Warnock L, Gates A. Chest physiotherapy compared to no chest physiotherapy for cystic fibrosis. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD001401. doi: 10.1002/14651858.CD001401.pub3.
- Background: PubMed 24814623Punithavathi N, Ong LM, Irfhan Ali HA, Mohd Izmi IA, Dharminy T, Ang AH, Hadzlinda Z, Sivasangari S. A Pilot Randomized Control Cross over Study Evaluating the Effectiveness and Safety of Mechanical Percussor Compared with Conventional Chest Physiotherapy in Adults with Productive Cough. Med J Malaysia. 2014 Feb;69(1):16-20.
- Background: PubMed 11676741Blazey S, Jenkins S, Smith R. Rate and force of application of manual chest percussion by physiotherapists. Aust J Physiother. 1998;44(4):257-264. doi: 10.1016/s0004-9514(14)60385-8.
- Background: PubMed 17827650Gregson RK, Stocks J, Petley GW, Shannon H, Warner JO, Jagannathan R, Main E. Simultaneous measurement of force and respiratory profiles during chest physiotherapy in ventilated children. Physiol Meas. 2007 Sep;28(9):1017-28. doi: 10.1088/0967-3334/28/9/004. Epub 2007 Aug 21.
- Background: PubMed 9390886Hardy KA, Anderson BD. Noninvasive clearance of airway secretions. Respir Care Clin N Am. 1996 Jun;2(2):323-45.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis in people with Cystic Fibrosis in Children, run by West Park Healthcare Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and user questionnaire (time frame: Through study completion, average 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835376, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.