- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 .
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Garches, Frankrig, 92380
- Hôpital Raymond Poincaré
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Rehabilitation Group
People with spinal cord injury who have a rehabilitation program on a word prediction software with an occupational therapist.
|
Rehabilitation program with an occupational therpasit 3 training sessions (one hour) per week for a month (12 sessions) |
Aktiv komparator: 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
|
Only instructions for a self - training at home
|
Ingen indgriben: No treatment Group
People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software.
They have no treatment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from Text Input Speed at 1 month
Tidsramme: Phase 1 After every test (10 minutes) Phase 2 : 1 months
|
text input speed (characters/minute)
|
Phase 1 After every test (10 minutes) Phase 2 : 1 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from Errors at 1 month
Tidsramme: Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
We record errors in text entry test
|
Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Change from Prediction use at 1 month
Tidsramme: Phase after every test (10 minutes) Phase 2 : 1 month
|
Number of use of word prediction software
|
Phase after every test (10 minutes) Phase 2 : 1 month
|
Change from Satisfaction
Tidsramme: Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Satisfaction of people with spinal cord injury about word prediction software (visual analogue scale)
|
Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Change from Cognitive load at 1 month
Tidsramme: Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Cognitive load of people with spinal cord injury (visual analogue scale)
|
Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Change from Speed sensation at 1 month
Tidsramme: Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
speed sensation of people with spinal cord injury with word prediction software (visual analogue scale)
|
Phase 1 After every test (10 minutes) Phase 2 : 1 month
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Djamel Bensmail, MDPHD, Hôpital Raymond Poincaré
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12053
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Rehabiliteringsprogram
-
Healthy Relationships CaliforniaRekrutteringProgram ModalitetForenede Stater
-
Hospices Civils de LyonRekruttering
-
National Yang Ming UniversityAfsluttet
-
Geisinger ClinicAfsluttetSundhedsfremme | Wellness programForenede Stater
-
Healthy Relationships CaliforniaRekrutteringProgram ModalitetForenede Stater
-
Burdur Mehmet Akif Ersoy UniversityAfsluttet
-
Oregon Health and Science UniversityUniversity of Michigan; University of Texas; HealthPartners Institute; Case... og andre samarbejdspartnereAfsluttet
-
Badalona Serveis AssistencialsRosa Maria Sequera Requero; Sebastià J. Santaeugènia González; Francisco...UkendtHjemmepleje | Managed Care Program
-
Hospices Civils de LyonIkke rekrutterer endnu
-
Washington University School of MedicineNational Cancer Institute (NCI)AfsluttetBrug af tobak | Program BæredygtighedForenede Stater
Kliniske forsøg med Rehabilitation program
-
The Hong Kong Polytechnic UniversityAfsluttet
-
First Affiliated Hospital of Shantou University...RekrutteringRekonstruktion af forreste korsbånd (ACL). | Præoperativ genoptræningKina
-
University of AlbertaRekrutteringKronisk obstruktiv lungesygdomCanada
-
Karolinska InstitutetAfsluttetSlag | Afasi | Apraxia af taleSverige
-
Emory UniversityNational Institute on Aging (NIA)RekrutteringProdromal Alzheimers sygdomForenede Stater
-
Shirley Ryan AbilityLabWashington University School of MedicineRekruttering
-
Spaulding Rehabilitation HospitalNortheastern UniversityAfsluttetGanggenoptræning i sunde fag | Ganggenoplæring i slagtilfældeoverlevereForenede Stater
-
Universidad Pública de NavarraMutua NavarraUkendtSkulderpåvirkning | Rotator Cuff sygdomSpanien
-
Scuola Superiore Sant'Anna di PisaAzienda Ospedaliero, Universitaria PisanaAfsluttetKronisk sygdom | Genoptræning af slagtilfælde | Cerebrovaskulær ulykke (CVA)Italien
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalUkendt