- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 .
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Garches, France, 92380
- Hôpital Raymond Poincaré
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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) |
Active Comparator: 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
|
No Intervention: No treatment Group
People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software.
They have no treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Text Input Speed at 1 month
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Errors at 1 month
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Study Director: Djamel Bensmail, MDPHD, Hôpital Raymond Poincaré
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rehabilitation Program
-
Chulalongkorn UniversityThammasat UniversityCompletedHydrotherapy | Ankle Instability | Sports Rehabilitation ProgramThailand
-
University Hospital, Clermont-FerrandClinique Médicale Cardio-Pneumologique de DurtolTerminatedRehabilitation Program | Chronic Heart Failure PatientFrance
-
University of MosulCompletedRehabilitation | Spinal Cord Injury | Exercises ProgramTunisia
-
Pusan National University Yangsan HospitalNot yet recruitingRehabilitation | Spinal Cord Injuries | Exercise Program
-
University of OuluOulu University Hospital; University of Eastern Finland; Verve Research, Oulu...UnknownCost-effectiveness of Exercise-based Rehabilitation ProgramFinland
-
University Hospital, BordeauxRecruitingCardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCADFrance
-
University of TorontoCompletedPrenatal Community Program | Vulnerable Population | Postnatal Community ProgramCanada
-
University Hospital, LilleUnknownLow Back Pain | Muscular Weakness | Rehabilitation ProgramFrance
-
Healthy Relationships CaliforniaRecruitingProgram ModalityUnited States
-
Hospices Civils de LyonRecruiting
Clinical Trials on Rehabilitation program
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...Completed
-
University Hospital, LimogesRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingQuality of Life | Facial Palsy | Motor Recovery | Self-rehabilitationFrance
-
University Hospital, GrenobleCompletedPeripheral Arterial Disease | ClaudicationFrance
-
Borja Alcobía-Díaz MD, PhDNot yet recruiting
-
Fundación Pública Andaluza para la gestión de la...Unknown
-
Assuta Hospital SystemsCompletedMyocardial Infarction | Return to Work | Sick Leave | Case ManagerIsrael
-
Istanbul UniversityCompletedRotator Cuff Tear | Pain, ShoulderTurkey
-
University of CalgaryAirCast LLC; Calgary Health Region; Olympic Oval Endowment Fund; Fitter International...Completed
-
University Hospital, BrestCompleted