ALS patients, etc. (patients with neuromuscular diseases including patients with myopathy) for whom speech, writing, and keyboard input are not practical, and are inputting letters using communication devices, etc. with existing switches.
Conditions
Interventions
Intervention type:
Name of intervention:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:
Sponsors
Takashi Nakajima
Akihiro Kawata,Yoshiki Adachi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient who is able to show his/her intention to consent with communication devices, etc. by himself/herself and is able to provide consent written by others on behalf of him/her, after receiving explanation on consent under a fair witness's presence and it is confirmed that the subject himself/herself agrees to participate in the study; 2.Patient aged 18 years or older at the time of providing consent; For patients under the age of 20, in addition to confirmation of his/her consent, name/seal or signature of a person who has parental authority, legal guardian, or spouse is required. 3.Patient who can input 20 characters by using communication devices, etc. with an existing switch. Also, patient who is practically limited to one part of operation with existing switches. In addition, when letters are selected by the gaze (stare) method and confirmed with existing switches, it is practically limited to one part. 4.Patient who can receive help from an AI02 attachment support person when using AI02 and the existing switch 5.Patient who is able to cooperate with the study in accordance with the clinical trial schedule
Exclusion criteria
Exclusion criteria: 1.Patients whose general condition is not stable due to dyspnea, cardiac failure, other complications, etc. 2.Patient who judges that AI02 is difficult to use at the same part as existing switch 3.Patients who cannot use the sensor (electrode) of AI02 due to skin diseases, etc. 4.Patients who have participated in other clinical trials over the past four weeks 5.Patients who the principal investigator deemed ineligible for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Accuracy Tool (TAT) input speed (times/minute) when using AI02 (main part) and existing switch | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of usable parts of AI02 (other than main part) 2.TAT input speed (times/minute) when using AI02 (other than main part) 3.Accuracy of TAT input timing (TAT average score) when AI02 (main part) and existing switch are used 4.Whether or not 20 characters can be entered in the communication devices, etc., the input time and adjusted time until completing the input of 20 characters, and the number of adjustments, when AI02 (main part) and existing switch are used. 5.Stability after one hour of TAT input speed (times/minute) when AI02 (main part) is used 6.Subjective evaluation by patients themselves (Japanese version of the Decision Regret Scale:DRS) 7.A 5-grade subjective comparative-evaluation with the existing switch by the patient him/herself and the AI02 attachment support person | — |
Countries
Japan
Contacts
Public ContactTakashi Nakajima
Niigata National Hospital,National Hospital Organization
Outcome results
None listed