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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Motivation, Usability and Functionality of an Intelligent Activity-based Client-centred Training System in Neurological Rehabilitation: a Pilot Study

Conditions
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Central Nervous System Diseases, Neurological Rehabilitation

Intervention / Treatment
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* Device: an intelligent client-centred task-oriented training
* Other: Semi-structured interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mixed-method pilot study in which persons with central nervous system diseases and occupational therapists were included
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persons with central nervous system diseases<br>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. | Device: an intelligent client-centred task-oriented training<br>* 3 x 45min of training with i-ACT system<br>* Other names: i-ACT;Other: Semi-structured interview<br>* Participants, patients and therapists, were invited to a semi-structured interview after training period.<br>|
| Other: Occupational therapists<br>Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT. | Other: Semi-structured interview<br>* Participants, patients and therapists, were invited to a semi-structured interview after training period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 2 weeks | 
| Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 4 weeks | 
| Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 6 weeks | 
| Intrinsic Motivation Inventory | Motivation towards a therapy, in this i-ACT | 12 weeks (i.e. 6 weeks follow-up) | 
| System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 2 weeks | 
| System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 4 weeks | 
| System Usability Scale | Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive). | 6 weeks | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | Baseline | 
| Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 2 weeks | 
| Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 4 Weeks | 
| Manual Ability Measure-36 | Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform) | 6 weeks | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| Active Range of Motion | Active range of motion | Baseline | 
| Active Range of Motion | Active range of motion | 2 weeks | 
| Active Range of Motion | Active range of motion | 4 weeks | 
| Active Range of Motion | Active range of motion | 6 weeks | 
| Active Range of Motion | Active range of motion | 12 weeks (i.e. 6 weeks follow-up) |