Intelligent Activity-based Client-centred Training

NCT ID: NCT02982811

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-06-26

Brief Summary

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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.).

Detailed Description

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Conditions

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Central Nervous System Diseases Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

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

Group Type EXPERIMENTAL

i-ACT

Intervention Type DEVICE

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.)

Interventions

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i-ACT

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.)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role collaborator

PXL University College

OTHER

Sponsor Role lead

Responsible Party

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Els Knippenberg

Researcher and PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annemie Spooren, Prof. Dr.

Role: STUDY_DIRECTOR

Centre of Expertise - Innovation in Care

Locations

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Jessa Hospital - rehabilitation campus St-Ursula

Herk-de-Stad, Limburg, Belgium

Site Status

Ziekenhuis Oost Limburg

Lanaken, Limburg, Belgium

Site Status

Revalidatie en MS centrum

Overpelt, Limburg, Belgium

Site Status

St-Trudo hospital

Sint-Truiden, Limburg, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 34961531 (View on PubMed)

Other Identifiers

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i-ACT2

Identifier Type: -

Identifier Source: org_study_id

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