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Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation (i-ACT)

Primary Purpose

Central Nervous System Diseases, Neurological Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
an intelligent client-centred task-oriented training
Semi-structured interview
Sponsored by
PXL University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Central Nervous System Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age over 18 years old
  • a medical diagnosis of central nervous system disease
  • dysfunction in upper limb and/or core stability
  • Persons with multiple sclerosis (MS) had to be free of treatment with corticosteroids for one month.
  • Persons with stroke or spinal cord injury, had to be at least three months post injury.

Exclusion Criteria:

  • severe spasticity (when spasticity impedes movement)
  • severe cognitive impairment (person is not able to understand and follow instructions)
  • severe communicative impairment (person is not able to answer questions)
  • severe visual impairment (person is not able to see the television screen)
  • persons who use an electric wheelchair

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Persons with central nervous system diseases

    Occupational therapists

    Arm Description

    Persons with central nervous system diseases received additional training with i-ACT during 6 weeks. After final training, a semi-structured interview was performed. And at six weeks follow-up, a final assessment took place.

    Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT.

    Outcomes

    Primary Outcome Measures

    Intrinsic Motivation Inventory
    Motivation towards a therapy, in this i-ACT
    Intrinsic Motivation Inventory
    Motivation towards a therapy, in this i-ACT
    Intrinsic Motivation Inventory
    Motivation towards a therapy, in this i-ACT
    Intrinsic Motivation Inventory
    Motivation towards a therapy, in this i-ACT
    System Usability Scale
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    System Usability Scale
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    System Usability Scale
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    System Usability Scale
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    Credibility/Expectancy Questionnaire
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Credibility/Expectancy Questionnaire
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Credibility/Expectancy Questionnaire
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Credibility/Expectancy Questionnaire
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Canadian Occupational Performance Measure
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Canadian Occupational Performance Measure
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Canadian Occupational Performance Measure
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Canadian Occupational Performance Measure
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Wolf Motor Function Test
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Wolf Motor Function Test
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Wolf Motor Function Test
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Wolf Motor Function Test
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Wolf Motor Function Test
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).

    Secondary Outcome Measures

    Manual Ability Measure-36
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Manual Ability Measure-36
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Manual Ability Measure-36
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Manual Ability Measure-36
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Manual Ability Measure-36
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Modified Fatigue Impact Scale
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Modified Fatigue Impact Scale
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Modified Fatigue Impact Scale
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Modified Fatigue Impact Scale
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Modified Fatigue Impact Scale
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Trunk Impairment Scale
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Trunk Impairment Scale
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Trunk Impairment Scale
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Trunk Impairment Scale
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Trunk Impairment Scale
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Active Range of Motion
    Active range of motion
    Active Range of Motion
    Active range of motion
    Active Range of Motion
    Active range of motion
    Active Range of Motion
    Active range of motion
    Active Range of Motion
    Active range of motion

    Full Information

    First Posted
    December 21, 2020
    Last Updated
    December 30, 2020
    Sponsor
    PXL University College
    Collaborators
    Hasselt University, Hogeschool West-Vlaanderen, Jessa Hospital, Ziekenhuis Oost-Limburg, Revalidatie & MS Centrum Overpelt, Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04692311
    Brief Title
    Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation
    Acronym
    i-ACT
    Official Title
    Motivation, Usability and Functionality of an Intelligent Activity-based Client-centred Training System in Neurological Rehabilitation: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 4, 2016 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    August 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    PXL University College
    Collaborators
    Hasselt University, Hogeschool West-Vlaanderen, Jessa Hospital, Ziekenhuis Oost-Limburg, Revalidatie & MS Centrum Overpelt, Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The pilot study was performed to evaluate the usability, credibility and expectancy of an intelligent, activity-based client-centred training system (i-ACT), and the motivation towards its use in neurological rehabilitation over a short period of time.
    Detailed Description
    A mixed-method study was performed in four rehabilitation centres in Belgium. An homogenous convenience sample was recruited among persons with central nervous system disorders. Participants received 3 x 45 minutes of training with the i-ACT system during six weeks, additional to conventional care. The Canadian Occupational Performance Measure (COPM) was used to collect and evaluate patients' individual goals towards rehabilitation. These goals were discussed with the therapists before implementing movements and exercises for each patient in the i-ACT system. The following demographic data were obtained from the medical files: age, gender, and diagnosis. Outcomes measures were collected at baseline (T0), after 2 (T1), 4 (T2) and 6 (T3) weeks of training and at 9 weeks follow-up (T4). The primary outcome measures were the Intrinsic Motivation Inventory (IMI), the System Usability Scale (SUS), Credibility/Expectancy Questionnaire (CEQ), the Canadian Occupational Performance Measure (COPM), and Wolf Motor Function Test (WMFT). The secondary measures were the Manual Ability Measure-36 (MAM-36), Modified Fatigue Impact Scale (MFIS), Trunk Impairment Scale (TIS), and Active Range of Motion (AROM). After final training with i-ACT, a semi-structured interview was performed to gather more information about the participants' perception towards i-ACT. For quantitative data, within-group differences of all the assessments were analysed using Friedman's ANOVA and Wilcoxon signed-rank test. Alpha was set at 0.05; No Bonferroni correction was applied as it is not compulsory in an exploratory study and furthermore, results are regarded as hypothesis for further investigations. The qualitative data was collected and recorded with a voice recorder. No specific analysis was used as the interview collected data to support or oppose the findings of the quantitative data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Nervous System Diseases, Neurological Rehabilitation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Mixed-method pilot study in which persons with central nervous system diseases and occupational therapists were included
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Persons with central nervous system diseases
    Arm Type
    Experimental
    Arm Description
    Persons with central nervous system diseases received additional training with i-ACT during 6 weeks. After final training, a semi-structured interview was performed. And at six weeks follow-up, a final assessment took place.
    Arm Title
    Occupational therapists
    Arm Type
    Other
    Arm Description
    Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT.
    Intervention Type
    Device
    Intervention Name(s)
    an intelligent client-centred task-oriented training
    Other Intervention Name(s)
    i-ACT
    Intervention Description
    3 x 45min of training with i-ACT system
    Intervention Type
    Other
    Intervention Name(s)
    Semi-structured interview
    Intervention Description
    Participants, patients and therapists, were invited to a semi-structured interview after training period.
    Primary Outcome Measure Information:
    Title
    Intrinsic Motivation Inventory
    Description
    Motivation towards a therapy, in this i-ACT
    Time Frame
    2 weeks
    Title
    Intrinsic Motivation Inventory
    Description
    Motivation towards a therapy, in this i-ACT
    Time Frame
    4 weeks
    Title
    Intrinsic Motivation Inventory
    Description
    Motivation towards a therapy, in this i-ACT
    Time Frame
    6 weeks
    Title
    Intrinsic Motivation Inventory
    Description
    Motivation towards a therapy, in this i-ACT
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    System Usability Scale
    Description
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    Time Frame
    2 weeks
    Title
    System Usability Scale
    Description
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    Time Frame
    4 weeks
    Title
    System Usability Scale
    Description
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    Time Frame
    6 weeks
    Title
    System Usability Scale
    Description
    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    Credibility/Expectancy Questionnaire
    Description
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Time Frame
    2 weeks
    Title
    Credibility/Expectancy Questionnaire
    Description
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Time Frame
    4 weeks
    Title
    Credibility/Expectancy Questionnaire
    Description
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Time Frame
    6 weeks
    Title
    Credibility/Expectancy Questionnaire
    Description
    Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    Canadian Occupational Performance Measure
    Description
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Time Frame
    Baseline
    Title
    Canadian Occupational Performance Measure
    Description
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Time Frame
    4 weeks
    Title
    Canadian Occupational Performance Measure
    Description
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Time Frame
    6 weeks
    Title
    Canadian Occupational Performance Measure
    Description
    By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    Wolf Motor Function Test
    Description
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Time Frame
    Baseline
    Title
    Wolf Motor Function Test
    Description
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Time Frame
    2 weeks
    Title
    Wolf Motor Function Test
    Description
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Time Frame
    4 weeks
    Title
    Wolf Motor Function Test
    Description
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Time Frame
    6 weeks
    Title
    Wolf Motor Function Test
    Description
    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Secondary Outcome Measure Information:
    Title
    Manual Ability Measure-36
    Description
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Time Frame
    Baseline
    Title
    Manual Ability Measure-36
    Description
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Time Frame
    2 weeks
    Title
    Manual Ability Measure-36
    Description
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Time Frame
    4 Weeks
    Title
    Manual Ability Measure-36
    Description
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Time Frame
    6 weeks
    Title
    Manual Ability Measure-36
    Description
    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    Modified Fatigue Impact Scale
    Description
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Time Frame
    Baseline
    Title
    Modified Fatigue Impact Scale
    Description
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Time Frame
    2 weeks
    Title
    Modified Fatigue Impact Scale
    Description
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Time Frame
    4 weeks
    Title
    Modified Fatigue Impact Scale
    Description
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Time Frame
    6 weeks
    Title
    Modified Fatigue Impact Scale
    Description
    Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    Trunk Impairment Scale
    Description
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Time Frame
    Baseline
    Title
    Trunk Impairment Scale
    Description
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Time Frame
    2 weeks
    Title
    Trunk Impairment Scale
    Description
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Time Frame
    4 weeks
    Title
    Trunk Impairment Scale
    Description
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Time Frame
    6 weeks
    Title
    Trunk Impairment Scale
    Description
    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)
    Title
    Active Range of Motion
    Description
    Active range of motion
    Time Frame
    Baseline
    Title
    Active Range of Motion
    Description
    Active range of motion
    Time Frame
    2 weeks
    Title
    Active Range of Motion
    Description
    Active range of motion
    Time Frame
    4 weeks
    Title
    Active Range of Motion
    Description
    Active range of motion
    Time Frame
    6 weeks
    Title
    Active Range of Motion
    Description
    Active range of motion
    Time Frame
    12 weeks (i.e. 6 weeks follow-up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age over 18 years old a medical diagnosis of central nervous system disease dysfunction in upper limb and/or core stability Persons with multiple sclerosis (MS) had to be free of treatment with corticosteroids for one month. Persons with stroke or spinal cord injury, had to be at least three months post injury. Exclusion Criteria: severe spasticity (when spasticity impedes movement) severe cognitive impairment (person is not able to understand and follow instructions) severe communicative impairment (person is not able to answer questions) severe visual impairment (person is not able to see the television screen) persons who use an electric wheelchair
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Annemie Spooren, Prof.Dr
    Organizational Affiliation
    PXL University College
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Upon reasonable request, the data (in Dutch) can be shared with other researchers.

    Learn more about this trial

    Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation

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