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Evaluation of the Efficiency of Word Prediction Software to Text Input Speed for Tetraplegia (Smartwrite)

Primary Purpose

Settings Word Prediction Software, Rehabilitation Program

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rehabilitation program
Self - Training at home
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Settings Word Prediction Software focused on measuring word prediction software, text input speed, copm, occupational therapist, rehabilitation, spinal cord injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hopital Raymond Poincare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Rehabilitation Group

Self Training at Home Group

No treatment Group

Arm Description

People with spinal cord injury who have a rehabilitation program on a word prediction software with an occupational therapist.

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

People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software. They have no treatment.

Outcomes

Primary Outcome Measures

Change from Text Input Speed at 1 month
text input speed (characters/minute)

Secondary Outcome Measures

Change from Errors at 1 month
We record errors in text entry test
Change from Prediction use at 1 month
Number of use of word prediction software
Change from Satisfaction
Satisfaction of people with spinal cord injury about word prediction software (visual analogue scale)
Change from Cognitive load at 1 month
Cognitive load of people with spinal cord injury (visual analogue scale)
Change from Speed sensation at 1 month
speed sensation of people with spinal cord injury with word prediction software (visual analogue scale)

Full Information

First Posted
September 17, 2013
Last Updated
September 4, 2018
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT01953666
Brief Title
Evaluation of the Efficiency of Word Prediction Software to Text Input Speed for Tetraplegia
Acronym
Smartwrite
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Settings Word Prediction Software, Rehabilitation Program
Keywords
word prediction software, text input speed, copm, occupational therapist, rehabilitation, spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation Group
Arm Type
Experimental
Arm Description
People with spinal cord injury who have a rehabilitation program on a word prediction software with an occupational therapist.
Arm Title
Self Training at Home Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
No treatment Group
Arm Type
No Intervention
Arm Description
People with spinal cord injury who don't have instructions, rehabilitation programm on word prediction software. They have no treatment.
Intervention Type
Other
Intervention Name(s)
Rehabilitation program
Intervention Description
Rehabilitation program with an occupational therpasit 3 training sessions (one hour) per week for a month (12 sessions)
Intervention Type
Other
Intervention Name(s)
Self - Training at home
Intervention Description
Only instructions for a self - training at home
Primary Outcome Measure Information:
Title
Change from Text Input Speed at 1 month
Description
text input speed (characters/minute)
Time Frame
Phase 1 After every test (10 minutes) Phase 2 : 1 months
Secondary Outcome Measure Information:
Title
Change from Errors at 1 month
Description
We record errors in text entry test
Time Frame
Phase 1 After every test (10 minutes) Phase 2 : 1 month
Title
Change from Prediction use at 1 month
Description
Number of use of word prediction software
Time Frame
Phase after every test (10 minutes) Phase 2 : 1 month
Title
Change from Satisfaction
Description
Satisfaction of people with spinal cord injury about word prediction software (visual analogue scale)
Time Frame
Phase 1 After every test (10 minutes) Phase 2 : 1 month
Title
Change from Cognitive load at 1 month
Description
Cognitive load of people with spinal cord injury (visual analogue scale)
Time Frame
Phase 1 After every test (10 minutes) Phase 2 : 1 month
Title
Change from Speed sensation at 1 month
Description
speed sensation of people with spinal cord injury with word prediction software (visual analogue scale)
Time Frame
Phase 1 After every test (10 minutes) Phase 2 : 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djamel Bensmail, MDPHD
Organizational Affiliation
HOPITAL RAYMOND POINCARE
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

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Evaluation of the Efficiency of Word Prediction Software to Text Input Speed for Tetraplegia

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