Central Nervous System Diseases Clinical Trial
— i-ACTOfficial title:
Motivation, Usability and Functionality of an Intelligent Activity-based Client-centred Training System in Neurological Rehabilitation: a Pilot Study
Verified date | December 2020 |
Source | PXL University College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | August 31, 2016 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
PXL University College | Hasselt University, Hogeschool West-Vlaanderen, Jessa Hospital, Revalidatie & MS Centrum Overpelt, Universitaire Ziekenhuizen Leuven, Ziekenhuis Oost-Limburg |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 2 weeks | |
Primary | Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 4 weeks | |
Primary | Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 6 weeks | |
Primary | Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 12 weeks (i.e. 6 weeks follow-up) | |
Primary | System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 2 weeks | |
Primary | System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 4 weeks | |
Primary | System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 6 weeks | |
Primary | System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 12 weeks (i.e. 6 weeks follow-up) | |
Primary | 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. | 2 weeks | |
Primary | 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. | 4 weeks | |
Primary | 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. | 6 weeks | |
Primary | 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. | 12 weeks (i.e. 6 weeks follow-up) | |
Primary | 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. |
Baseline | |
Primary | 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. |
4 weeks | |
Primary | 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. |
6 weeks | |
Primary | 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. |
12 weeks (i.e. 6 weeks follow-up) | |
Primary | 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). | Baseline | |
Primary | 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). | 2 weeks | |
Primary | 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). | 4 weeks | |
Primary | 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). | 6 weeks | |
Primary | 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). | 12 weeks (i.e. 6 weeks follow-up) | |
Secondary | Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | Baseline | |
Secondary | Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 2 weeks | |
Secondary | Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 4 Weeks | |
Secondary | Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 6 weeks | |
Secondary | Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 12 weeks (i.e. 6 weeks follow-up) | |
Secondary | 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. . | Baseline | |
Secondary | 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. . | 2 weeks | |
Secondary | 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. . | 4 weeks | |
Secondary | 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. . | 6 weeks | |
Secondary | 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. . | 12 weeks (i.e. 6 weeks follow-up) | |
Secondary | 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. | Baseline | |
Secondary | 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. | 2 weeks | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 12 weeks (i.e. 6 weeks follow-up) | |
Secondary | Active Range of Motion | Active range of motion | Baseline | |
Secondary | Active Range of Motion | Active range of motion | 2 weeks | |
Secondary | Active Range of Motion | Active range of motion | 4 weeks | |
Secondary | Active Range of Motion | Active range of motion | 6 weeks | |
Secondary | Active Range of Motion | Active range of motion | 12 weeks (i.e. 6 weeks follow-up) |
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