Settings Word Prediction SoftwareSmartwriteNCT01953666
Evaluation of the Efficiency of Word Prediction Software to Text Input Speed for Tetraplegia
A study testing Rehabilitation program and Self - Training at home in people with Settings Word Prediction Software and Rehabilitation Program, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Settings Word Prediction Software, Rehabilitation Program
- What is being tested?
- Rehabilitation program and Self - Training at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Moving in progress or predictable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Being tested
- Rehabilitation program, Self - Training at home
- Keywords
- word prediction software, text input speed, copm, occupational therapist, rehabilitation, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
Rehabilitation program with an occupational therpasit
3 training sessions (one hour) per week for a month (12 sessions)
Self - Training at homeOther
Only instructions for a self - training at home
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | Experimental | People with spinal cord injury who have a rehabilitation program on a word prediction software with an occupational therapist. Receives: Other: Rehabilitation program |
| Self Training at Home Group | Active comparator | 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 Receives: Other: Self - Training at home |
| No treatment Group | No intervention | People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software. They have no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Text Input Speed at 1 month
text input speed (characters/minute)
Measured: Phase 1 After every test (10 minutes) Phase 2 : 1 months
Secondary outcomes (5)
Change from Errors at 1 month
We record errors in text entry test
Measured: Phase 1 After every test (10 minutes) Phase 2 : 1 month
Change from Prediction use at 1 month
Number of use of word prediction software
Measured: Phase after every test (10 minutes) Phase 2 : 1 month
Change from Satisfaction
Satisfaction of people with spinal cord injury about word prediction software (visual analogue scale)
Measured: Phase 1 After every test (10 minutes) Phase 2 : 1 month
Change from Cognitive load at 1 month
Cognitive load of people with spinal cord injury (visual analogue scale)
Measured: Phase 1 After every test (10 minutes) Phase 2 : 1 month
Change from Speed sensation at 1 month
speed sensation of people with spinal cord injury with word prediction software (visual analogue scale)
Measured: Phase 1 After every test (10 minutes) Phase 2 : 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Settings Word Prediction SoftwareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouplin Samuel, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Djamel Bensmail, MDPHD, Study director, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953666
- Sponsor's protocol ID
- 12053
- Acronym
- Smartwrite
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2013
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01953666
- Acronym / sponsor ID
- Smartwrite / 12053
- Keywords
- word prediction software, text input speed, copm, occupational therapist, rehabilitation, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | Experimental | Other: Rehabilitation programPeople with spinal cord injury who have a rehabilitation program on a word prediction software with an occupational therapist. |
| Self Training at Home Group | Active comparator | Other: Self - Training at homePeople 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 |
| No treatment Group | No intervention | –People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software. They have no treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Moving in progress or predictable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation programRehabilitation program with an occupational therpasit 3 training sessions (one hour) per week for a month (12 sessions) | Other | Rehabilitation Group |
| Self - Training at homeOnly instructions for a self - training at home | Other | Self Training at Home Group |
Primary outcome
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)
5 secondary outcomes
Change from Errors at 1 month
Time frame: 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
Change from Satisfaction
Time frame: 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
Change from Speed sensation at 1 month
Time frame: Phase 1 After every test (10 minutes) Phase 2 : 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamel Bensmail, MDPHD study director
HOPITAL RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program and Self - Training at home in people with Settings Word Prediction Software and Rehabilitation Program, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Text Input Speed at 1 month (time frame: Phase 1 After every test (10 minutes) Phase 2 : 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.