Clinical trial NCT04692311: Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation
Official title: Motivation, Usability and Functionality of an Intelligent Activity-based Client-centred Training System in Neurological Rehabilitation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Nervous System Diseases
Neurological Rehabilitation
Lead sponsor: PXL University College
Sponsor class: OTHER
Collaborators: name: Hasselt University
name: Hogeschool West-Vlaanderen
name: Jessa Hospital
name: Ziekenhuis Oost-Limburg
name: Revalidatie & MS Centrum Overpelt
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2020-12-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed-method pilot study in which persons with central nervous system diseases and occupational therapists were included
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intrinsic Motivation Inventory
timeFrame: 2 weeks
measure: Intrinsic Motivation Inventory
timeFrame: 4 weeks
measure: Intrinsic Motivation Inventory
timeFrame: 6 weeks
measure: Intrinsic Motivation Inventory
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: System Usability Scale
timeFrame: 2 weeks
measure: System Usability Scale
timeFrame: 4 weeks
measure: System Usability Scale
timeFrame: 6 weeks
measure: System Usability Scale
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: Credibility/Expectancy Questionnaire
timeFrame: 2 weeks
measure: Credibility/Expectancy Questionnaire
timeFrame: 4 weeks
measure: Credibility/Expectancy Questionnaire
timeFrame: 6 weeks
measure: Credibility/Expectancy Questionnaire
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: Canadian Occupational Performance Measure
timeFrame: Baseline
measure: Canadian Occupational Performance Measure
timeFrame: 4 weeks
measure: Canadian Occupational Performance Measure
timeFrame: 6 weeks
measure: Canadian Occupational Performance Measure
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: Wolf Motor Function Test
timeFrame: Baseline
measure: Wolf Motor Function Test
timeFrame: 2 weeks
measure: Wolf Motor Function Test
timeFrame: 4 weeks
measure: Wolf Motor Function Test
timeFrame: 6 weeks
measure: Wolf Motor Function Test
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
Secondary outcomes:
measure: Manual Ability Measure-36
timeFrame: Baseline
measure: Manual Ability Measure-36
timeFrame: 2 weeks
measure: Manual Ability Measure-36
timeFrame: 4 Weeks
measure: Manual Ability Measure-36
timeFrame: 6 weeks
measure: Manual Ability Measure-36
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: Modified Fatigue Impact Scale
timeFrame: Baseline
measure: Modified Fatigue Impact Scale
timeFrame: 2 weeks
measure: Modified Fatigue Impact Scale
timeFrame: 4 weeks
measure: Modified Fatigue Impact Scale
timeFrame: 6 weeks
measure: Modified Fatigue Impact Scale
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: Trunk Impairment Scale
timeFrame: Baseline
measure: Trunk Impairment Scale
timeFrame: 2 weeks
measure: Trunk Impairment Scale
timeFrame: 4 weeks
measure: Trunk Impairment Scale
timeFrame: 6 weeks
measure: Trunk Impairment Scale
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
measure: Active Range of Motion
timeFrame: Baseline
measure: Active Range of Motion
timeFrame: 2 weeks
measure: Active Range of Motion
timeFrame: 4 weeks
measure: Active Range of Motion
timeFrame: 6 weeks
measure: Active Range of Motion
timeFrame: 12 weeks (i.e. 6 weeks follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: PXL University College
name: Annemie Spooren, Prof.Dr
role: STUDY_CHAIR
References: