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
About this trial
This is an interventional supportive care trial for Central Nervous System Diseases
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
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
NCT ID
NCT04692311
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
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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