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The efficacy of C-Mill training after stroke


- candidate number14976
- NTR NumberNTR4030
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2013
- Secondary IDsNL42461.029.13 METc VUmc
- Public TitleThe efficacy of C-Mill training after stroke
- Scientific TitleThe efficacy of C-Mill training for improving walking ability, walking speed and gait adaptability in people post stroke: a single-centre RCT
- ACRONYMC-Stroke
- hypothesisFor most people with stroke, regaining the ability to walk in their communities is of high importance. Community walking, however, requires the ability to adjust gait relative to the environment in order to avoid obstacles for example. Since the ability to adjust gait is often impaired after stroke, improving gait adaptability after stroke might improve safe community walking. The C-Mill, a treadmill that allows for projecting visual obstacles and targets on the beltsí surface, has recently shown positive effects in that regard. The main objective of the current study is to examine the relative efficacy of C-Mill gait adaptability treadmill training compared to the Nijmegen Falls Prevention Program (NFP program) for improving walking ability aspects, particularly walking speed and gait adaptability, in persons with stroke. It is hypothesized that C-Mill training will result in better outcomes than the NFP program as a result of its enhanced training intensity.
- Healt Condition(s) or Problem(s) studiedStroke, Exercise therapy, Treadmill, Gait adaptability
- Inclusion criteria1. First ever stroke > 3 months ago;
2. Clinically diagnosed with hemiparesis;
3. Age ≥ 18 years;
4. FAC ≥ 3;
5. Simple instructions must be understood and executed.
- Exclusion criteria1. Other pre-existing orthopaedic or neurological disorders that influence walking (e.g., Parkinsonís disease);
2. Moderate or severe cognitive impairment (as indicated by a score below 21 at the Mini Mental State Examination [MMSE]);
3. Other treatments that could influence the effects of the interventions (e.g., recent Botox treatment of lower extremity);
4. Contraindication to physical activity or practicing fall techniques (e.g., heart failure, osteoporosis);
5. Severe visual deficits which limit the correct perception of the patientís direct environment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-jun-2013
- planned closingdate1-nov-2015
- Target number of participants50
- Interventions1. C-Mill gait adaptability training: C-Mill gait adaptability training is treadmill training with a specific emphasis on training gait adaptability. The C-Mill is an instrumented treadmill that was specifically developed to provide task-specific, functional gait training based on individually measured gait characteristics. During C-Mill training, participants practice to control foot positioning on a step-to-step basis during walking by following an imposed step pattern with variation in step length, practice avoidance of real-virtual visual obstacles that are projected on the treadmill, and practice to accelerate and decelerate gait by following a projected walking zone moving in anterior-posterior direction relative to the treadmill. C-Mill gait adaptability training is provided 2 times per week for 90 minutes in groups of 2 participants for 5 consecutive weeks.

2.Nijmegen Falls Prevention (NFP) program: the NFP program is an overground, dose-matched training program developed to reduce the number of falls in community-dwelling elderly. Balance and coordination are practiced and integrated in an obstacle avoidance course that simulates potential challenging situations of daily life. These exercises also have to be performed while cognitive and motor dual tasks are imposed, as well as under visual constraints. In addition, the program incorporates exercises to simulate walking in a crowded environment. The NFP program is provided 2 times per week for 90 minutes in groups of 5 participants for 5 consecutive weeks.

Both intervention programs are matched in therapy duration (15h in total), frequency (2 times per week) and therapist-attention (1 therapist for 2 participants).
- Primary outcomeThe primary outcome measures are walking speed as assessed with the 10 m walk test and gait adaptability as assessed with instrumented 10 m walk tests (i.e., obstacle avoidance and dual task walking).
- Secondary outcomeSecondary parameters are commonly used gait and balance related clinimetric measures (e.g., Functional Ambulation Categories , Timed Up-and-Go test, Berg Balance Scale ) as well as on fear of falling (Activities-specific Balance Confidence scale).
- Timepoints1. Pre-intervention (week 1);
2. Post - intervention (week 6);
3. Retention (4 weeks post-intervention);
4. 12 month follow-up.
- Trial web sitehttp://www.move.vu.nl/nl/onderzoek/c-mill-kennisplatform/lopende-projecten/steps-to-follow/index.asp
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. M.W. Ooijen - Kerste, van
- CONTACT for SCIENTIFIC QUERIESDr. Melvyn Roerdink
- Sponsor/Initiator MOVE
- Funding
(Source(s) of Monetary or Material Support)
MOVE Research Institute
- PublicationsN/A
- Brief summaryAlmost one third of people with stroke remain unable to walk without supervision in their communities. For most people with stroke, regaining the ability to walk in their communities is of high importance. Community walking, however, requires the ability to adjust gait relative to the environment in order to avoid obstacles for example. Since the ability to adjust gait is often impaired after stroke, improving gait adaptability after stroke might improve safe community walking. The C-Mill, a treadmill that allows for projecting visual obstacles and targets on the beltsí surface, has recently shown positive effects in that regard.

The main objective of the proposed study is to examine the relative efficacy of C-Mill gait adaptability treadmill training compared to the Nijmegen Falls Prevention Program (NFP program) for improving walking ability aspects, particularly walking speed and gait adaptability , in persons with stroke.

In this study, walking ability, walking speed and gait adaptability in a group of participants receiving 5 weeks of C-Mill gait adaptability training is compared with that of a group receiving 5 weeks of the lower-intensity, overground NFP program. This study is a single-centre randomized controlled trial with pre-tests, post-tests, retention tests and 12 month follow-up. It is expected that C-Mill gait adaptability training will result in better outcomes than the NFP program as a result of its enhanced training intensity.
- Main changes (audit trail)
- RECORD11-jun-2013 - 27-jun-2013


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