|- candidate number||27573|
|- NTR Number||NTR6557|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jul-2017|
|- Secondary IDs||NL53300.091.15 CMO|
|- Public Title||Effect van looptraining op het evenwicht na een beroerte|
|- Scientific Title||The effect of dynamic balance training on balance capacity in people after stroke|
|- ACRONYM||Balance capacity in people after stroke|
|- hypothesis||We hypothesize that persons who receive dynamic balance training with visual perturbations (Visual Perturbed intervention) will show larger improvements on the ability to make step adjustments (and thus show a larger difference in foot placement error between pre and post intervention) compared to persons in the Mechanical Perturbed intervention and Inactive Control intervention. Furthermore, we expect that persons receiving the Mechanical Perturbed intervention will show the largest improvements on the stepping test, as shown by a larger difference between pre and post intervention in the leg angle at stepping foot contact.|
|- Healt Condition(s) or Problem(s) studied||Stroke, Balans, Balans training|
|- Inclusion criteria||-Having sustained a unilateral supratentorial stroke more than 6 months ago with
hemiparesis involving the leg.|
- Consequences of the stroke were severe enough to get inpatient rehabilitation in a
- Having the capacity to stand and walk ‘independently’ as defined by a Functional
Ambulation Categories scores 4 or 5.
- 18 years or older.
|- Exclusion criteria||- Any other neurological or musculoskeletal conditions affecting balance.|
- Current orthopaedic problems; current hip or knee replacement, or limb
- Severe cognitive problems (Montreal Cognitive Assessment < 24).
- Persistent visuo-spatial neglect (Star-Cancellation Test < 44) .
- Use of psychotropic drugs or other medication negatively affecting balance.
- Behavioural problems interfering with compliance to the study protocol.
- Unable to stand for 15 minutes without orthosis or walking aid.
- Unable to give a personal consent.
- Conditions in which physical exercise is contra-indicated.
- Unable to walk for 10 minutes without walking aid.
- Receiving physiotherapy focusing at balance or gait which cannot be cancelled
during participation in this study, except for participants receiving the Inactive
Control intervention. (These participants do not have to cancel usual physiotherapy focusing on balance or gait during participation in this study).
- Having received dynamic balance training with visual and/or mechanical perturbations beforehand.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-aug-2017|
|- planned closingdate||28-feb-2019|
|- Target number of participants||60|
|- Interventions||• Participants will be randomized in one of the three interventions; two interventions consist of dynamic balance training on the C-mill (treadmill) and one intervention consist of no training (Inactive Control intervention). Participants will receive dynamic balance training during training sessions of 60 minutes, two times a week, during 5 weeks. Dynamic balance training consists of walking on the C-mill with augmented visual context (Visual Perturbed intervention), or walking on the C-mill with mechanical perturbations (Mechanical Perturbed intervention).|
|- Primary outcome||Main outcome variables are the frequency response function (feet-in-place test), leg angle at stepping foot contact (stepping test) and foot placement error (step adjustment test).|
|- Secondary outcome||Secondary outcomes of the feet-in-place test are values for the parameters describing the physics of human balance control. The most important parameters are passive muscle stiffness and damping, reflexive muscle stiffness and damping and time delay. For the stepping test, the secondary outcome variables are step onset, step duration, step length and step velocity. For the step adjustment test, the secondary outcome variables are onset latencies of stepping adjustments and average speed of adjustments. Furthermore, clinical tests (10 meter walking test and mini-BEST test) and activity levels will be evaluated.|
|- Timepoints||Week 1: pre intervention balance assessment and pre intervention activity monitoring|
Week 2 – 6: intervention
Week 7: post intervention balance assessment and post intervention activity monitoring
|- Trial web site||Not applicable|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Jolanda Roelofs|
|- CONTACT for SCIENTIFIC QUERIES|| Jolanda Roelofs|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, University of Technology, Delft, Sint Maartenskliniek Nijmegen, Tolbrug Specialistische Revalidatie, Den Bosch, Pieter van Foreest, Delft, Amstelland Fysiotherapie|
(Source(s) of Monetary or Material Support)
|- Publications||Not applicable|
|- Brief summary||People after stroke are at a high risk of falls. Impaired balance and gait are important risk factors for a fall in this population. Previous research has shown that the feet-in-place test, stepping test and step adjustment test were sensitive to evaluate training effects in people after stroke. Despite proven sensitivity, the specificity of test outcomes to various types of training provided is still unknown. More insight in these aspects is definitely needed to determine whether the feet-in-place test, stepping test and/or step adjustment test provide additional information (compared to clinical tests) that is necessary for further improvement and individualization of stroke care.|
|- Main changes (audit trail)|
|- RECORD||21-jul-2017 - 6-aug-2017|