Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation
- Conditions
- Neurological RehabilitationCentral Nervous System Diseases
- Interventions
- Device: an intelligent client-centred task-oriented trainingOther: Semi-structured interview
- Registration Number
- NCT04692311
- Lead Sponsor
- PXL University College
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Persons with central nervous system diseases an intelligent client-centred task-oriented training 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. Persons with central nervous system diseases Semi-structured interview 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 Semi-structured interview Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT.
- Primary Outcome Measures
Name Time Method Intrinsic Motivation Inventory 12 weeks (i.e. 6 weeks follow-up) Motivation towards a therapy, in this i-ACT
Credibility/Expectancy Questionnaire 12 weeks (i.e. 6 weeks follow-up) 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 12 weeks (i.e. 6 weeks follow-up) 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.System Usability Scale 12 weeks (i.e. 6 weeks follow-up) Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Wolf Motor Function Test 12 weeks (i.e. 6 weeks follow-up) 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
Name Time Method Active Range of Motion 12 weeks (i.e. 6 weeks follow-up) Active range of motion
Modified Fatigue Impact Scale 12 weeks (i.e. 6 weeks follow-up) 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. .
Manual Ability Measure-36 12 weeks (i.e. 6 weeks follow-up) Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
Trunk Impairment Scale 12 weeks (i.e. 6 weeks follow-up) Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.