Skip to main content
OpenTrials
Completed

NCT Number: NCT04692311

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Nervous System Diseases Nervous System Diseases Neurological Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

an intelligent client-centred task-oriented training

Device

3 x 45min of training with i-ACT system

Other names: i-ACT

semi-structured interview

Other

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

Primary outcomes

  1. Intrinsic Motivation Inventory

    Time frame: 2 weeks

    Motivation towards a therapy, in this i-ACT

  2. Intrinsic Motivation Inventory

    Time frame: 4 weeks

    Motivation towards a therapy, in this i-ACT

  3. Intrinsic Motivation Inventory

    Time frame: 6 weeks

    Motivation towards a therapy, in this i-ACT

  4. Intrinsic Motivation Inventory

    Time frame: 12 weeks (i.e. 6 weeks follow-up)

    Motivation towards a therapy, in this i-ACT

  5. System Usability Scale

    Time frame: 2 weeks

    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).

  6. System Usability Scale

    Time frame: 4 weeks

    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).

  7. System Usability Scale

    Time frame: 6 weeks

    Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).

  8. System Usability Scale

    Time frame: 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).

  9. Credibility/Expectancy Questionnaire

    Time frame: 2 weeks

    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.

  10. Credibility/Expectancy Questionnaire

    Time frame: 4 weeks

    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.

  11. Credibility/Expectancy Questionnaire

    Time frame: 6 weeks

    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. Credibility/Expectancy Questionnaire

    Time frame: 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.

  13. Canadian Occupational Performance Measure

    Time frame: Baseline

    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.

  14. Canadian Occupational Performance Measure

    Time frame: 4 weeks

    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.

  15. Canadian Occupational Performance Measure

    Time frame: 6 weeks

    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.

  16. Canadian Occupational Performance Measure

    Time frame: 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.

  17. Wolf Motor Function Test

    Time frame: Baseline

    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).

  18. Wolf Motor Function Test

    Time frame: 2 weeks

    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).

  19. Wolf Motor Function Test

    Time frame: 4 weeks

    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).

  20. Wolf Motor Function Test

    Time frame: 6 weeks

    Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).

  21. Wolf Motor Function Test

    Time frame: 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 outcomes

  1. Manual Ability Measure-36

    Time frame: Baseline

    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)

  2. Manual Ability Measure-36

    Time frame: 2 weeks

    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)

  3. Manual Ability Measure-36

    Time frame: 4 Weeks

    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)

  4. Manual Ability Measure-36

    Time frame: 6 weeks

    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)

  5. Manual Ability Measure-36

    Time frame: 12 weeks (i.e. 6 weeks follow-up)

    Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)

  6. Modified Fatigue Impact Scale

    Time frame: Baseline

    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. .

  7. Modified Fatigue Impact Scale

    Time frame: 2 weeks

    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. .

  8. Modified Fatigue Impact Scale

    Time frame: 4 weeks

    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. .

  9. Modified Fatigue Impact Scale

    Time frame: 6 weeks

    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. .

  10. Modified Fatigue Impact Scale

    Time frame: 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. .

  11. Trunk Impairment Scale

    Time frame: Baseline

    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.

  12. Trunk Impairment Scale

    Time frame: 2 weeks

    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.

  13. Trunk Impairment Scale

    Time frame: 4 weeks

    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.

  14. Trunk Impairment Scale

    Time frame: 6 weeks

    Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.

  15. Trunk Impairment Scale

    Time frame: 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.

  16. Active Range of Motion

    Time frame: Baseline

    Active range of motion

  17. Active Range of Motion

    Time frame: 2 weeks

    Active range of motion

  18. Active Range of Motion

    Time frame: 4 weeks

    Active range of motion

  19. Active Range of Motion

    Time frame: 6 weeks

    Active range of motion

  20. Active Range of Motion

    Time frame: 12 weeks (i.e. 6 weeks follow-up)

    Active range of motion

Sponsors and collaborators

Lead sponsor

PXL University College

Other

Collaborators

  • Hasselt University
  • Hogeschool West-Vlaanderen
  • Jessa Hospital
  • Revalidatie & MS Centrum Overpelt
  • Universitaire Ziekenhuizen KU Leuven
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: i-ACT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2020
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.