Clinical trial NCT02982811: Intelligent Activity-based Client-centred Training
Official title: Intelligent Activity-based Client-centred Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Nervous System Diseases
Aged
Keywords: Activity-based
Client-centred
Rehabilitation
Quality of life
Lead sponsor: PXL University College
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: Ziekenhuis Oost-Limburg
name: Hasselt University
First posted: 2016-12-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).


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

Primary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
measure: Short Form 36 (SF-36)
timeFrame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
Secondary outcomes:
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: After 6 weeks of training, only persons in experimental group
measure: Manual Ability Measure (MAM-36)
timeFrame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
measure: Trunk Impairment Scale (TIS)
timeFrame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
measure: Active Range of Motion (AROM)
timeFrame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: At baseline, after 6 weeks of training, and 6 weeks follow-up
Other outcomes:
Locations:
city: Herk-de-Stad
country: Belgium
facility: Jessa Hospital - rehabilitation campus St-Ursula
state: Limburg
city: Lanaken
country: Belgium
facility: Ziekenhuis Oost Limburg
state: Limburg
city: Overpelt
country: Belgium
facility: Revalidatie en MS centrum
state: Limburg
city: Sint-Truiden
country: Belgium
facility: St-Trudo hospital
state: Limburg
Study officials:
affiliation: Centre of Expertise - Innovation in Care
name: Annemie Spooren, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.