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Intelligent Activity-based Client-centred Training (i-ACT)

Primary Purpose

Central Nervous System Diseases, Aged

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
i-ACT
Sponsored by
PXL University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Diseases focused on measuring Activity-based, Client-centred, Rehabilitation, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medical diagnosis of central nervous system disease (e.g. multiple sclerosis, stroke, spinal cord, etc.)
  • Be able to understand and respond to questions in Dutch
  • Actively involved in a rehabilitation programme in the participating rehabilitation centres
  • Have a dysfunction in upper and/or lower limb and/or core stability
  • Specifically for multiple sclerosis: min. of one month without corticosteroids
  • Specifically for stroke and spinal cord: min. 3 months post injury

Exclusion Criteria:

  • Severe spasticity which prevent performing basic functional exercises
  • Severe cognitive and communicative impairment which prevent the person to understand and respond to Dutch instructions
  • Severe visual impairment, e.g. blindness, cataract, etc.
  • Pregnancy
  • Persons who use an electrical wheelchair, who can not transfer safely into a normal chair and perform the exercises

Sites / Locations

  • Jessa Hospital - rehabilitation campus St-Ursula
  • Ziekenhuis Oost Limburg
  • Revalidatie en MS centrum
  • St-Trudo hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Therapy as usual, i.e. occupational therapy, physiotherapy, etc.

Therapy as usual together with 3x45min training with i-ACT system during 6 weeks.

Outcomes

Primary Outcome Measures

Wolf Motor Function Test (WMFT)
Evaluation of upper extremity
Short Form 36 (SF-36)
Evaluation of general health status and quality of life

Secondary Outcome Measures

Intrinsic Motivation Inventory (IMI)
Evaluation of motivation towards using the system in neurorehabilitation
Manual Ability Measure (MAM-36)
Evaluation of performance of manual tasks
Modified Fatigue Impact Scale (MFIS)
Evaluation of fatigue
Trunk Impairment Scale (TIS)
Evaluation of sitting, standing and core stability
Active Range of Motion (AROM)
Evaluation of active range of motion
Canadian Occupational Performance Measure (COPM)
Evaluation of self-perception of performance of ADL tasks

Full Information

First Posted
November 29, 2016
Last Updated
July 23, 2020
Sponsor
PXL University College
Collaborators
Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT02982811
Brief Title
Intelligent Activity-based Client-centred Training
Acronym
i-ACT
Official Title
Intelligent Activity-based Client-centred Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
PXL University College
Collaborators
Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether additional therapy with i-ACT system is effective in the training of functional skills in persons with central neurological diseases (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Diseases, Aged
Keywords
Activity-based, Client-centred, Rehabilitation, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Therapy as usual, i.e. occupational therapy, physiotherapy, etc.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Therapy as usual together with 3x45min training with i-ACT system during 6 weeks.
Intervention Type
Device
Intervention Name(s)
i-ACT
Intervention Description
3x 45 min training with i-ACT system (analytical and functional training) during 6 weeks, additional to therapy as usual (i.e. occupational therapy, physiotherapy, etc.)
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
Evaluation of upper extremity
Time Frame
At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Title
Short Form 36 (SF-36)
Description
Evaluation of general health status and quality of life
Time Frame
At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Secondary Outcome Measure Information:
Title
Intrinsic Motivation Inventory (IMI)
Description
Evaluation of motivation towards using the system in neurorehabilitation
Time Frame
After 6 weeks of training, only persons in experimental group
Title
Manual Ability Measure (MAM-36)
Description
Evaluation of performance of manual tasks
Time Frame
At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Title
Modified Fatigue Impact Scale (MFIS)
Description
Evaluation of fatigue
Time Frame
At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Title
Trunk Impairment Scale (TIS)
Description
Evaluation of sitting, standing and core stability
Time Frame
At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Title
Active Range of Motion (AROM)
Description
Evaluation of active range of motion
Time Frame
At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Title
Canadian Occupational Performance Measure (COPM)
Description
Evaluation of self-perception of performance of ADL tasks
Time Frame
At baseline, after 6 weeks of training, and 6 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medical diagnosis of central nervous system disease (e.g. multiple sclerosis, stroke, spinal cord, etc.) Be able to understand and respond to questions in Dutch Actively involved in a rehabilitation programme in the participating rehabilitation centres Have a dysfunction in upper and/or lower limb and/or core stability Specifically for multiple sclerosis: min. of one month without corticosteroids Specifically for stroke and spinal cord: min. 3 months post injury Exclusion Criteria: Severe spasticity which prevent performing basic functional exercises Severe cognitive and communicative impairment which prevent the person to understand and respond to Dutch instructions Severe visual impairment, e.g. blindness, cataract, etc. Pregnancy Persons who use an electrical wheelchair, who can not transfer safely into a normal chair and perform the exercises
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Spooren, Prof. Dr.
Organizational Affiliation
Centre of Expertise - Innovation in Care
Official's Role
Study Director
Facility Information:
Facility Name
Jessa Hospital - rehabilitation campus St-Ursula
City
Herk-de-Stad
State/Province
Limburg
ZIP/Postal Code
3540
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg
City
Lanaken
State/Province
Limburg
ZIP/Postal Code
3620
Country
Belgium
Facility Name
Revalidatie en MS centrum
City
Overpelt
State/Province
Limburg
ZIP/Postal Code
3900
Country
Belgium
Facility Name
St-Trudo hospital
City
Sint-Truiden
State/Province
Limburg
ZIP/Postal Code
3800
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34961531
Citation
Knippenberg E, Timmermans A, Coolen J, Neven K, Hallet P, Lemmens J, Spooren A. Efficacy of a technology-based client-centred training system in neurological rehabilitation: a randomised controlled trial. J Neuroeng Rehabil. 2021 Dec 28;18(1):184. doi: 10.1186/s12984-021-00977-2.
Results Reference
derived

Learn more about this trial

Intelligent Activity-based Client-centred Training

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