- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01953666
Evaluation of the Efficiency of Word Prediction Software to Text Input Speed for Tetraplegia (Smartwrite)
Phase 1 Evaluation of the Influence of Settings of Word Prediction Software (Phase 1)and the Efficiency of Rehabilitation Programm (Phase 2)to Text Input Speed for People With Spinal Cord Injury
Computers now play an important role in the lives of most individuals.Access to computers is crucial for people with disabilities and may improve their quality of life. The use of computers can facilitate mainstreaming at school, for example, and the Internet may provide a valuable means of communication. However, the use of computers requires a certain degree of motor ability. People with motor disabilities frequently experience difficulties using a standard keyboard and standard pointing input systems such as a mouse. Many solutions exist to facilitate computer access, depending on the person's specific impairments and the purpose for which the computer is used. The most common solution relies on the use of a virtual keyboard which is directly displayed on the computer screen. The selection of the desired key on the virtual keyboard can be handled by a large variety of input devices, from a microgravity mouse to single switch devices supplemented by a process of dynamic scanning of the keyboard.Although such assistive devices render computers accessible to people with disabilities, the actual inputting of text can be very slow. A method to increase text input speed is to display words which are predicted from the letters previously typed. Word prediction reduces the number of necessary key strokes by avoiding having to type the whole word. The effect on text input speed is, however uncertain and results in the literature are inconclusive. Indeed, word prediction software provide a enhancement of cognitive load which decrease text input speed.The reduction of cognitive load could therefore be based in part on the optimization settings of the software and / or achievement of a rehabilitation program.Our hypothesis are for people with spinal cord injury : i) optimization settings word prediction software and ii) a rehabilitation program could improve the text input speed.The investigators propose to study the influence of settings word prediction software on text input speed and the influence of a rehabilitation program provided by a therapist, focused on word prediction software to help integrate them. The aim is to increase the performance of people with spinal cord injury and their satisfaction.
The first phase of this research is to select the word prediction software and configuration that provides the best user support.The second phase corresponds to the objective of evaluating the efficiency of a rehabilitation program .
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
PHASE 1 : The first phase studied the repeated measurement of the efficiency of typing text topics in various situations. Each subject will copy a text different in each test and in a random order. Similarly, if the word prediction software has a capacity for self-improvement the internal dictionary, it will be disabled.
the investigators will study one setting of the configuration word prediction software. Are available the length of the list of proposals for which three options are selected: 1, 3 or 5 words, according to the literature and to the results of a questionnaire.This questionnaire was sent to identify the use of people with spinal cord injury and professionals about word prediction software.
The list of words is in the upper position of the screen based on the results of the questionnaire.
Four combinations will be tested on each subject. Twelve Tetraplegics will be required in each group (one group using a virtual keyboard and one group using the physical keyboard) Each combination will be tried for 10 minutes.
PHASE 2 :
The second phase will evaluate the effeciency of a rehabilitation program reduced cognitive load generated by the software predictions words.
The investigators propose an evaluation of the effects of 12 training sessions in a controlled, randomized, three parallel groups (experimental group : rehabilitation program, a group : a self-learning and a group : no learning).
Text input tests will be performed before and after the training sessions for people who have rehabilitation program. For the other two groups, those will be reviewed one month after the first test.
For this evaluation, a different text but with the same difficulty will be used. The order of execution will be randomized.
At the end of the month the three groups will be evaluated according to the same procedures for the firts test.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Garches, Francia, 92380
- Hôpital Raymond Poincaré
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Tetraplegia (between C4 and C8 ASIA) more than 6 months.
- Can read and write
- No visual problems preventing the use of computers.
- Recipient of a Health Insurance Plan
- Having read information note.
Exclusion Criteria:
- Moving in progress or predictable
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Rehabilitation Group
People with spinal cord injury who have a rehabilitation program on a word prediction software with an occupational therapist.
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Rehabilitation program with an occupational therpasit 3 training sessions (one hour) per week for a month (12 sessions) |
|
Comparatore attivo: Self Training at Home Group
People with spinal cord injury who don't have a rehabilitation program with an occupational therapist but who have instructions for learning at home on a word prediction software
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Only instructions for a self - training at home
|
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Nessun intervento: No treatment Group
People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software.
They have no treatment.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Text Input Speed at 1 month
Lasso di tempo: Phase 1 After every test (10 minutes) Phase 2 : 1 months
|
text input speed (characters/minute)
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Phase 1 After every test (10 minutes) Phase 2 : 1 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Errors at 1 month
Lasso di tempo: Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
We record errors in text entry test
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Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
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Change from Prediction use at 1 month
Lasso di tempo: Phase after every test (10 minutes) Phase 2 : 1 month
|
Number of use of word prediction software
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Phase after every test (10 minutes) Phase 2 : 1 month
|
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Change from Satisfaction
Lasso di tempo: Phase 1 After every test (10 minutes) Phase 2 : 1 month
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Satisfaction of people with spinal cord injury about word prediction software (visual analogue scale)
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Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
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Change from Cognitive load at 1 month
Lasso di tempo: Phase 1 After every test (10 minutes) Phase 2 : 1 month
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Cognitive load of people with spinal cord injury (visual analogue scale)
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Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
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Change from Speed sensation at 1 month
Lasso di tempo: Phase 1 After every test (10 minutes) Phase 2 : 1 month
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speed sensation of people with spinal cord injury with word prediction software (visual analogue scale)
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Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Djamel Bensmail, MDPHD, Hôpital Raymond Poincaré
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12053
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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