Primary objective:1) Does individually tailored robotic gait training with the LOPES II result in more reduction of mechanical work during walking and more improvement of gait symmetry than conventional gait training (of similar frequency and…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the quality of gait pattern as reflected by its
mechanical efficiency. The mechanical work during walking can be derived from
the movements of the Center of Mass (CoM). Because any improvement in gait
symmetry will lead to smoother CoM trajectory, the CoM displacement will be
used as a *composite* primary outcome that is applicable in every participant
(independent of individual pre-set goals).
The individual pre-set goals are being trained using subtasks. OUcome
parameters of the different subtasks are:
- Efficiency; mechanical work derived from CoM displacement
- Stability in Stance: knee and hip angles during single stance, step width and
single stance symmetry
- Foot clearance: peak hip, knee and foot angles during swing phase, minimal
footclearance during swing phase
- Foot prepositioning: peak knee extension and ankle dorsiflexion angles in
terminal swing
- Step length: step length and step length symmetry
Secondary outcome
Secundary parameters are:
- leg motor function, measured with:
> leg score Fugl-Meyer Assessment
> Motricity Index
> Range of Motion hip, knee and ankle
- Walking ability, measured with:
> 10 meter walking test
> 6 minutes walking test
> Timed Up and Go test
> Dynamic Gait Index
- Patients' experience with walking in LOPESII, measured with
> System Usability Scale
> Intrinsic Motivation Inventory
Background summary
Stroke is a major cause of gait disability. Although regaining a (nearly)
normal gait pattern is an important goal for stroke survivors, no exercise
therapy has shown to improve the quality of gait after stroke. Robotic gait
trainers might provide such an opportunity, but existing robots are based on a
*one-size-fits-all* principle and insufficiently promote active learning. Newer
generation robotic gait trainers, such as LOPES II, are designed to only assist
selected subtasks of gait and promote active participation. These robots might,
therefore, be able to support the relearning of an optimal gait pattern in the
subacute phase of stroke, avoiding inadequate compensation strategies.
Study objective
Primary objective:
1) Does individually tailored robotic gait training with the LOPES II result in
more reduction of mechanical work during walking and more improvement of gait
symmetry than conventional gait training (of similar frequency and duration) in
stroke subacute survivors who have at least a minimum level of gait
independency?
Secondary objectives:
2) What is the effect of gait training in LOPES II on individual patients*
goals compared to the conventional gait training?
3) What is the effect of gait training in LOPES II on walking ability (walking
speed, walking distance and dynamic balance) compared to conventional gait
training?
4) What is the patients* experience with robotic gait training?
Study design
The proposed study is a two-center assessor-blinded Randomized Controlled Trial
Intervention
Subjects will be randomised into two intervention groups:
- the experimental group receives 3 times per week gait training in LOPESII for
30 minutes per session during 6 weeks. The training will be
complemented with maximal 2 conventional gait training sessions of 30
minutes per week by a physiotherapist. During the training the focus is on
the individual set goals for improvement of gait.
- the control group receives conventional gait training by a physiotherpist 3
to 5 times per week for 30 minutes per session during a 6-weeks training
period. The goal of training is also improvement of patients' individual
goals for gait.
Frequency of therapies will be equal and controlled for both groups during the
study.
Study burden and risks
Gait training is a common therapy during inpatient rehabilitation after stroke.
The frequency of the given interventions is not exceeding the frequency of gait
training during the rehabilitation program of these patients (FAC=>3). The
study is part of the inpatient rehabilitation program. During the study,
subjects will receive five gait training sessions a week during a period of six
weeks.
The clinical measurements are also common measurements during the
rehabilitation of stroke patients. Gait analysis and transcranial magnetic
stimulation are frequent used methods in experimental studies. The time for
measurements is extensive, so rest is possible for the patients.
The training and the measurements will be accomponied by an experienced
physiotherapist who will take care of the patient.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
- adults (>18 years) with a first-ever or secondary unilateral ischemic or haemorrhagic supratentorial stroke
- Functional Ambulation Category (FAC) <=> 3
- impaired quality of gait related to one of the five possible training goals ((efficiency, stability in stance, foot clearance, foot prepositioning and step length)
- stable cardiopulmonary and general medical condition
- Mini Mental State Examination (MMSE) > 22
- sufficient communication ability (Utrechts Communicatie Onderzoek > 2)
- Signed informed consent
Exclusion criteria
- insufficient mastery of the Dutch language
- serious orthopaedic disorders interfering with gait
- other neurological disorders
- depressed mood (Hospital Anxiety and Depression Scale > 7)
- No independent ambulation prior to stroke
- chronic (joint) pain
- severe spasticity interfering with robotic support
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50748.044.14 |
| OMON | NL-OMON26996 |