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Motor activation for people with profound intellectual and multiple disabilities


- candidate number26683
- NTR NumberNTR6627
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-feb-2017
- Secondary IDsVJ2015-04 Programmaraad visuele sector
- Public TitleMotor activation for people with profound intellectual and multiple disabilities
- Scientific TitleFeasibility and effects of an individualized motor activation program for people with profound intellectual and multiple disabilities
- ACRONYM
- hypothesisA motor activation program benefits the number of motor activities which can improve several domains of human functioning
- Healt Condition(s) or Problem(s) studiedMotor activation, Intellectual deficits
- Inclusion criteria1. Severe / profound intellectual disability: estimated IQ below 35 or a developmental age up to 36 months.
2. Severe / profound motor disability: not able to walk (GMFCS IV-V) and the functional use of the arms is very limited.
3. Visual impairment: visus < 0.3
- Exclusion criteria1. Dementia
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2017
- planned closingdate1-sep-2019
- Target number of participants30
- InterventionsIndividualized motor activation program:
- Motor activation within ADL
- 3-5 motor activities per week
- Primary outcomeNumber and type of motor activities (diary)
- Secondary outcome1. Alertness (video)
2. Challenging behaviour (video and Behaviour Problems Inventory (Dutch translation))
3. Obstipation (Bristol Stool Scale)
4. Sleep (Actiwatch)
5. Functional possibilities (Gedragstaxatie instrument)
6. Saturation (Nonin GO2)
7. Body mass index (weigh plateau for wheelchairs, measuring tape)
- Timepoints- Baseline 1 (T0)
- Baseline 2 after 8 weeks (T1)
- Staff will be trained during 8 weeks
- Measurement of primary and seconday outcomes after 12 weeks (T2)
- Measurement of primary outcome again after 8 weeks (T3)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Leentje van Alphen
- CONTACT for SCIENTIFIC QUERIES Leentje van Alphen
- Sponsor/Initiator University of Groningen - Faculty of Behavioural and Social Sciences
- Funding
(Source(s) of Monetary or Material Support)
Programmaraad Visuele sector, University of Groningen - Faculty of Behavioural and Social Sciences
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD10-feb-2017 - 20-aug-2017


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