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van CCT (UK)

The effect of an assist-as-needed algorithm applied by a robotic gait trainer on walking in neurologic patients.

- candidate number14087
- NTR NumberNTR3747
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-dec-2012
- Secondary IDsNL42426.044.12 CCMO
- Public TitleThe effect of an assist-as-needed algorithm applied by a robotic gait trainer on walking in neurologic patients.
- Scientific TitleThe effect of an assist-as-needed-algorithm in stroke and SCI patients.
- hypothesisThe use of an assist-as-needed algorithm applied by a robotic gait trainer during rehabilitation will resemble walking freely on a treadmill and overground locomotor training in neurologic patients more than a position controlled algorithm.
- Healt Condition(s) or Problem(s) studiedRehabilitation, Assist-as-needed, Robotics, Locomotor training, Neurologic patients, Walking
- Inclusion criteria1. Age > 18 years;
2. A stable medical condition;
3. A physical condition which allows for 1 minute of supported walking;
4. A first ever motor incomplete SCI or stroke.
- Exclusion criteria1. Current orthopedic problems;
2. Other neurological disorders;
3. A history of cardiac or pulmonary conditions that interfere with physical load;
4. No independent ambulation prior to SCI or stroke;
5. Chronic joint pain;
6. Inapproriate or unsafe fit of the robotic gait trainer due to the participants body size (>140kg) and/or joint contractures.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2103
- planned closingdate1-apr-2017
- Target number of participants56
- InterventionsAn Assist-as-Needed algorithm will be applied by a robotic gait trainer, LOPES II. A position-controlled algorithm will be applied as control.
- Primary outcomeThe primary outcome is walking quality, expressed by kinematics and spatio-temporal parameters.
- Secondary outcomeSecondary outcomes are muscle function, walking ability and energy consumption.
- TimepointsIn a cross-sectional trial, the first part of the study, the timepoints are directly after applying the intervention. In a training study, the second part of the study, the timepoints are at 3, 6 and 8 weeks.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Pieken in Delta Oost Nederland
- PublicationsN/A
- Brief summaryThe last decade, there is an increasing interest in the use of robotic gait trainers during the rehabilitation of spinal cord injured patients and patients who suffered from a stroke. Current robotic gait trainers have not been proven to be more effective than other gait training. These robotic gait trainers are position-controlled and have limited Degrees of Freedom. Treatment outcome could be optimized by promoting active participation of the patient. A more active approach is the assist-as-needed algorithm as implemented in LOPES II. LOPES II is an impedance controller, which is able to adjust joint stiffness to the capabilities of the patient from high (robot-in-charge) to zero (zero-impedance). In addition, LOPES II is a selective task controller. It is capable of only supporting selected phases of the gait cycle that are affected. Because of the increase in Degrees of Freedom compensatory movements are allowed by LOPES. Besides being used as a gait trainer, LOPES II can be used to measure joint movements and spatio-temporal parameters during gait.
The implementation of an assist-as-needed algorithm in human is quite new. Little is known about the underlying mechanism of this algorithm. This study will focus on the different effects of the assist-as-needed algorithm on walking compared to the position-controlled algorithm.
- Main changes (audit trail)
- RECORD12-dec-2012 - 4-jan-2013

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