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

Central Nervous System Diseases Clinical Trial

— i-ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692311
• Other study ID #: i-ACT pilot
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: August 31, 2016

Study information

• Verified date: December 2020
• Source: PXL University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases
• Neurological Rehabilitation

Intervention

Device:
• an intelligent client-centred task-oriented training
3 x 45min of training with i-ACT system

Other:
• Semi-structured interview
Participants, patients and therapists, were invited to a semi-structured interview after training period.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
PXL University College	Hasselt University, Hogeschool West-Vlaanderen, Jessa Hospital, Revalidatie & MS Centrum Overpelt, Universitaire Ziekenhuizen Leuven, Ziekenhuis Oost-Limburg

Outcome

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)