Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation (i-ACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Neurological Rehabilitation
• Intervention / Treatment: Device: an intelligent client-centred task-oriented training; Other: Semi-structured interview

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Persons with central nervous system diseases; 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; 3 x 45min of training with i-ACT system; Other Names: i-ACT; Other: Semi-structured interview; Participants, patients and therapists, were invited to a semi-structured interview after training period.
Other: Occupational therapists; Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT.	Other: Semi-structured interview; Participants, patients and therapists, were invited to a semi-structured interview after training period.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: PXL University College
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Hasselt University; Jessa Hospital; Ziekenhuis Oost-Limburg; Revalidatie & MS Centrum Overpelt; Hogeschool West-Vlaanderen
• Investigators: Study Chair: Annemie Spooren, Prof.Dr, PXL University College

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: i-ACT pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon reasonable request, the data (in Dutch) can be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No