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ID
Source
Brief title
Health condition
Stroke, gait adaptability, treadmill, exercise
Beroerte, stapaanpassingen tijdens lopen, loopband, oefenen
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
Secondary 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).
- gait adaptability as assessed with instrumented 10 m walk tests (i.e., obstacle avoidance and dual task walking).
Background summary
Almost 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 belts’ 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.
Study objective
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 belts’ 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.
Study design
1. Pre-intervention (week 1);
2. Post - intervention (week 6);
3. Retention (4 weeks post-intervention);
4. 12 month follow-up.
Intervention
1. 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).
- The amount of movement practice (the number of steps taken per session)’ as a process measure. This will be used to examine how the treatment might work if there is a between-group difference in the primary outcome for the trial. The number of steps taken per therapy session will be registered using the treadmill’s inbuilt step counter (C-Mill therapy) and by counting steps from video recordings (FALLS program).
VU University Amsterdam<br>
Van der Boechorststraat 9
M.W. Ooijen - Kerste, van
Amsterdam 1081 BT
The Netherlands
+31 (0)20 5988252
m.van.ooijen-kerste@vu.nl
VU University Amsterdam<br>
Van der Boechorststraat 9
M.W. Ooijen - Kerste, van
Amsterdam 1081 BT
The Netherlands
+31 (0)20 5988252
m.van.ooijen-kerste@vu.nl
Inclusion criteria
1. 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.
6. walking and/or balance deficits confirmed by a physician
Exclusion criteria
1. Other pre-existing orthopaedic or neurological disorders that influence walking (e.g., Parkinson’s 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 patient’s direct environment.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3842 |
NTR-old | NTR4030 |
CCMO | NL42461.029.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON40076 |