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

NCT04692311 | Completed

• 1 other identifier: i-ACT pilot
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Nervous System Diseases; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (20)

• Manual Ability Measure-36

  Baseline

• Manual Ability Measure-36

  2 weeks

• Manual Ability Measure-36

  4 Weeks

• Manual Ability Measure-36

  6 weeks

• Manual Ability Measure-36

  12 weeks (i.e. 6 weeks follow-up)

Study Arms (2)

Persons with central nervous system diseases

EXPERIMENTAL

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; Other: Semi-structured interview

Occupational therapists

OTHER

Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT.

Other: Semi-structured interview

Interventions

an intelligent client-centred task-oriented training DEVICE

3 x 45min of training with i-ACT system

Also known as: i-ACT

Persons with central nervous system diseases

Semi-structured interview OTHER

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

Occupational therapists; Persons with central nervous system diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Annemie Spooren, Prof.Dr

  PXL University College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Mixed-method pilot study in which persons with central nervous system diseases and occupational therapists were included

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 31, 2020
• Study Start: January 4, 2016
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share