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Uit balans


- candidate number28042
- NTR NumberNTR6763
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-okt-2017
- Secondary IDs17N140 METC
- Public TitleUit balans
- Scientific TitleEffects of dynamic supported standing practice on sit-and standingbalance in patients with sub-acute stroke: Pilotstudy
- ACRONYM
- hypothesisAccording to the current Dutch guidelines it is advised to train task-specific and goal-driven with stroke patients. This shows to be almost impossible with a lot of stroke patients in the early subacute phase, especially with the severely affected ones. Therefore only training in function remains. An essential part of this is to practice balance. The improvement of balance achieved by conventional physical therapy treatment are limited. The purpose of the study is to examine the effect of balance training with a dynamic supported standing frame compared to conventional physical therapy treatment on severely affected subacute stroke patients.
- Healt Condition(s) or Problem(s) studiedStroke, Physical therapy, Stroke, Balance, Neurological rehabilitation, Standing therapy
- Inclusion criteriaTrunk Control Test <100, Functional Ambulation Category °‹ 2, being able to stand in the dynamic supported standing frame for at least 15 minutes
- Exclusion criteriaDifferent diagnosis than stroke, more than three month after stroke, medically unstable, Glasgow Coma Scale <11, height <150 cm or >200 cm, weight >120 kg, vision disorder, aphasia, cognitive problems making the patient unable to understand instructions or giving informed consent, musculoskeletal problems of the lower extremity limiting standing or walking (e.g. fractur)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 26-okt-2017
- planned closingdate12-feb-2018
- Target number of participants30
- InterventionsIntervention: balance training with the dynamic supported standing frame
Control: conventional balance training within physical therapy treatment
- Primary outcomeSit and standing balance measured with the Berg Balance Scale (BBS) and the Trunk Control Test (TCT)
- Secondary outcomeMuscle strength of the lower extremity measured by the Motricity Index (MI), walking skills measured with the Functional Ambulation Category (FAC) and the independence on activities of daily living measured with the Barthel Index (BI)
- TimepointsT(0) intake
T(1) after 8 weeks of treatment
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES DaniŽlle Vreugdenburg
- CONTACT for SCIENTIFIC QUERIES Jeroen Dockx
- Sponsor/Initiator DaniŽlle Vreugdenburg
- Funding
(Source(s) of Monetary or Material Support)
DaniŽlle Vreugdenburg
- Publications
- Brief summaryObjective: To evaluate dynamic supported standig versus conventional balancetraining performed by patients with subacute stroke.
Design: pilotstudy
Setting: Geriatric rehabilitation centre
Participants: Non-ambulatory participants in the subacute phase after stroke
Intervention: Usual care that includes either balancetraining in a dynamic standing frame (intervention group) or conventional balancetraining (control group) for 6 weeks.
Main measures: Preliminary effectiveness was assessed with the Trunk Control Test and the Berg Blance Scale (primary outcome). Other measures of physical functioning are Barthel Index, Motricity Index of lower extremiy and the Functional Ambulation Category.
Recruitment in the Netherlands.
- Main changes (audit trail)
- RECORD24-okt-2017 - 4-nov-2017


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