Effectiveness of Jamboxx Respiratory Therapy Device: Study 1
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | May 1, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Nakesha Abel, PhD |
| Email: | abeln@amc.edu |
| Phone: | 518-262-2269 |
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 1: Spinal Cord Injury Patients for Long Term Evaluation
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with
Decreased Respiratory Function is a proposal for investigation of the application of gaming
to improving respiratory health. The Jamboxx device combines gaming with traditional
incentive spirometry to provide users with a fun experience to keep them engaged in their
respiratory therapy routine. The device allows users to play a series of mini-games that walk
them through their routines. The Jamboxx also records airflow and lung parameters with an
external mouthpiece attachment to provide users with real time feedback, and helps to assess
increases or decreases in relative lung function over time. The Jamboxx has the potential to
significantly impact the field of respiratory therapy by being one of the first gaming
devices for patient therapy, and the first respiratory therapy gaming device that is
accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost
alternative to the traditional therapy techniques used and aims to improve patient
compliance.
Decreased Respiratory Function is a proposal for investigation of the application of gaming
to improving respiratory health. The Jamboxx device combines gaming with traditional
incentive spirometry to provide users with a fun experience to keep them engaged in their
respiratory therapy routine. The device allows users to play a series of mini-games that walk
them through their routines. The Jamboxx also records airflow and lung parameters with an
external mouthpiece attachment to provide users with real time feedback, and helps to assess
increases or decreases in relative lung function over time. The Jamboxx has the potential to
significantly impact the field of respiratory therapy by being one of the first gaming
devices for patient therapy, and the first respiratory therapy gaming device that is
accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost
alternative to the traditional therapy techniques used and aims to improve patient
compliance.
Study 1 addresses the concerns of pneumonia risks in quadriplegics with compromised
respiratory pump mechanics. In cases of spinal cord injury or high-level motor neuron
disease, complications with respiratory function are a common concern. Lack of innervation to
the intercostal and abdominal muscles can cause a decline in respiratory capacity as well as
overall lung function, with associated increased risk of mortality. Shallow tidal breathing
and impaired or absent cough results in morbidity and mortality from pneumonia. Several
studies have found failure of the respiratory system, including pneumonia, to be a leading
cause of mortality among spinal cord injury patients. In order to maintain pulmonary health,
many people with quadriplegia and other high-level motor neuron diseases undergo routine
respiratory therapy to help stretch the muscles around the lungs, exercise the diaphragm, and
loosen mucus build-up. Incentive spirometry is one commonly used component of respiratory
therapy designed to mimic natural sighing or yawning by encouraging the patient to take long,
slow, deep breaths. This is done with an incentive spirometer device, which provides patients
with visual or other positive feedback with a piston or a ball that moves inside a gauge.
Respiratory therapy techniques are also used to help maintain pulmonary health in individuals
with a number of chronic or temporary respiratory diseases and conditions such as asthma,
chronic obstructive pulmonary disease, and emphysema. These techniques often become strenuous
and mundane for users with limited mobility, and thus patient compliance rates are low.
Gaming controlled by forceful respiratory maneuvers will be studied to ascertain if
respiratory mechanics can be improved in this group.
Testing Plan: Study participants will be randomized into 2 groups through drawing of sealed
envelopes. Group 1 (control group) will be given the standard Jamboxx musical device (see
appendix a for device details), while Group 2 (treatment group) will be given the Jamboxx
respiratory therapy device, which combines musical gameplay with incentive spirometry
exercises. Participants from both groups will have two 20 minute training sessions with the
device: one initial training visit and one follow up visit. Training sessions will take place
either in the home, or at Albany Medical Center. During the initial visit a simple spirometry
test (FEV1, FVC and PEF) and maximum inspiratory and expiratory pressures (MIP and MEP) will
be performed. These functions will be measured again at 3, 6, 9 & 12 months by a respiratory
therapist (RT). The Dyspnea-12 (D-12) questionnaire will be conducted at by the RT at months
0, 3, 6, 9, and 12. Self-Reported Patient Dyspnea and the Multidimensional Dyspnea Profile
(MDP) will be reported electronically by study participants on a weekly basis. Medical
records will be evaluated for relevant health history, medication use, and hospitalizations
including dates. Access to medical records will be obtained by a signed medical release form.
respiratory pump mechanics. In cases of spinal cord injury or high-level motor neuron
disease, complications with respiratory function are a common concern. Lack of innervation to
the intercostal and abdominal muscles can cause a decline in respiratory capacity as well as
overall lung function, with associated increased risk of mortality. Shallow tidal breathing
and impaired or absent cough results in morbidity and mortality from pneumonia. Several
studies have found failure of the respiratory system, including pneumonia, to be a leading
cause of mortality among spinal cord injury patients. In order to maintain pulmonary health,
many people with quadriplegia and other high-level motor neuron diseases undergo routine
respiratory therapy to help stretch the muscles around the lungs, exercise the diaphragm, and
loosen mucus build-up. Incentive spirometry is one commonly used component of respiratory
therapy designed to mimic natural sighing or yawning by encouraging the patient to take long,
slow, deep breaths. This is done with an incentive spirometer device, which provides patients
with visual or other positive feedback with a piston or a ball that moves inside a gauge.
Respiratory therapy techniques are also used to help maintain pulmonary health in individuals
with a number of chronic or temporary respiratory diseases and conditions such as asthma,
chronic obstructive pulmonary disease, and emphysema. These techniques often become strenuous
and mundane for users with limited mobility, and thus patient compliance rates are low.
Gaming controlled by forceful respiratory maneuvers will be studied to ascertain if
respiratory mechanics can be improved in this group.
Testing Plan: Study participants will be randomized into 2 groups through drawing of sealed
envelopes. Group 1 (control group) will be given the standard Jamboxx musical device (see
appendix a for device details), while Group 2 (treatment group) will be given the Jamboxx
respiratory therapy device, which combines musical gameplay with incentive spirometry
exercises. Participants from both groups will have two 20 minute training sessions with the
device: one initial training visit and one follow up visit. Training sessions will take place
either in the home, or at Albany Medical Center. During the initial visit a simple spirometry
test (FEV1, FVC and PEF) and maximum inspiratory and expiratory pressures (MIP and MEP) will
be performed. These functions will be measured again at 3, 6, 9 & 12 months by a respiratory
therapist (RT). The Dyspnea-12 (D-12) questionnaire will be conducted at by the RT at months
0, 3, 6, 9, and 12. Self-Reported Patient Dyspnea and the Multidimensional Dyspnea Profile
(MDP) will be reported electronically by study participants on a weekly basis. Medical
records will be evaluated for relevant health history, medication use, and hospitalizations
including dates. Access to medical records will be obtained by a signed medical release form.
Inclusion Criteria:
- Quadriplegic and other spinal cord injury outpatients will be included.
Exclusion Criteria:
- Individuals already adhering to a daily regimen of prescribed respiratory therapy
routine will be excluded.
We found this trial at
1
site
Click here to add this to my saved trials
