NCT01953666

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 17, 2013

Last Update Submit

September 4, 2018

Conditions

Keywords

word prediction software, text input speed, copm, occupational therapist, rehabilitation, spinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Change from Text Input Speed at 1 month

    text input speed (characters/minute)

    Phase 1 After every test (10 minutes) Phase 2 : 1 months

Secondary Outcomes (5)

  • Change from Errors at 1 month

    Phase 1 After every test (10 minutes) Phase 2 : 1 month

  • Change from Prediction use at 1 month

    Phase after every test (10 minutes) Phase 2 : 1 month

  • Change from Satisfaction

    Phase 1 After every test (10 minutes) Phase 2 : 1 month

  • Change from Cognitive load at 1 month

    Phase 1 After every test (10 minutes) Phase 2 : 1 month

  • Change from Speed sensation at 1 month

    Phase 1 After every test (10 minutes) Phase 2 : 1 month

Study Arms (3)

Rehabilitation Group

EXPERIMENTAL

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

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

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.

Interventions

Rehabilitation program with an occupational therpasit 3 training sessions (one hour) per week for a month (12 sessions)

Rehabilitation Group

Only instructions for a self - training at home

Self Training at Home Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Moving in progress or predictable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Djamel Bensmail, MDPHD

    HOPITAL RAYMOND POINCARE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ergotherapeute (Occupational Therapist)

Study Record Dates

First Submitted

September 17, 2013

First Posted

October 1, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

July 1, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Locations