Central Nervous System Diseasesi-ACTNCT02982811
Intelligent Activity-based Client-centred Training
A study testing i-ACT in people with Central Nervous System Diseases and Aged, run by PXL University College at 4 sites in Belgium.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Diseases, Aged
- What is being tested?
- i-ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesBelgium
- Study dates
- 1 Mar 2017to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Jessa Hospital - rehabilitation campus St-Ursula
Herk-de-Stad, Limburg, 3540
Ziekenhuis Oost Limburg
Lanaken, Limburg, 3620
Revalidatie en MS centrum
Overpelt, Limburg, 3900
St-Trudo hospital
Sint-Truiden, Limburg, 3800
About this study
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.).
- Conditions
- Central Nervous System Diseases, Aged
- Being tested
- i-ACT
- Keywords
- Activity-based, Client-centred, Rehabilitation, Quality of life
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-ACTDevice
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.)
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Therapy as usual, i.e. occupational therapy, physiotherapy, etc. |
| Experimental group | Experimental | Therapy as usual together with 3x45min training with i-ACT system during 6 weeks. Receives: Device: i-ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test (WMFT)
Evaluation of upper extremity
Measured: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Short Form 36 (SF-36)
Evaluation of general health status and quality of life
Measured: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Secondary outcomes (6)
Intrinsic Motivation Inventory (IMI)
Evaluation of motivation towards using the system in neurorehabilitation
Measured: After 6 weeks of training, only persons in experimental group
Manual Ability Measure (MAM-36)
Evaluation of performance of manual tasks
Measured: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Modified Fatigue Impact Scale (MFIS)
Evaluation of fatigue
Measured: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Trunk Impairment Scale (TIS)
Evaluation of sitting, standing and core stability
Measured: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Active Range of Motion (AROM)
Evaluation of active range of motion
Measured: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Canadian Occupational Performance Measure (COPM)
Evaluation of self-perception of performance of ADL tasks
Measured: At baseline, after 6 weeks of training, and 6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion31 May 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- PXL University College
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, Hasselt University
- Responsible party
- Principal investigator, Els Knippenberg, PXL University College
- Investigators
- Annemie Spooren, Prof. Dr., Study director, Centre of Expertise - Innovation in Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982811
- Sponsor's protocol ID
- i-ACT2
- Acronym
- i-ACT
- Status last verified
- Jul 2020
- First submitted
- 29 Nov 2016
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34961531
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Activity-based Client-centred Training
- ClinicalTrials.gov ID
- NCT02982811
- Acronym / sponsor ID
- i-ACT / i-ACT2
- Conditions
- Central Nervous System Diseases, Aged
- Keywords
- Activity-based, Client-centred, Rehabilitation, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PXL University CollegeUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, Hasselt University
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Therapy as usual, i.e. occupational therapy, physiotherapy, etc. |
| Experimental group | Experimental | Device: i-ACTTherapy as usual together with 3x45min training with i-ACT system during 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-ACT3x 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.) | Device | Experimental group |
Primary outcome
Wolf Motor Function Test (WMFT)
Time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Evaluation of upper extremity
Short Form 36 (SF-36)
Time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Evaluation of general health status and quality of life
6 secondary outcomes
Intrinsic Motivation Inventory (IMI)
Time frame: After 6 weeks of training, only persons in experimental group
Manual Ability Measure (MAM-36)
Time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Modified Fatigue Impact Scale (MFIS)
Time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Trunk Impairment Scale (TIS)
Time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Active Range of Motion (AROM)
Time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Canadian Occupational Performance Measure (COPM)
Time frame: At baseline, after 6 weeks of training, and 6 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Derived from this study: PubMed 34961531Knippenberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Spooren, Prof. Dr. study director
Centre of Expertise - Innovation in Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-ACT in people with Central Nervous System Diseases and Aged, run by PXL University College at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (WMFT) (time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.