Primary: - What are the effects of gait training with the gait rehabilitation device LOPES on the quality and ability of walking in chronic stroke patients with a stiff-knee gait?- What are the effects of two different training modes in the gait…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are 1) quality of walking, measured during gait analysis,
and 2) ability of walking, measured during various clinical tests. Furthermore,
a neurobiomechanical analysis is performed, to measure joint torque patterns,
and the adaptation capability is measured by sensors in LOPES.
Secondary outcome
Secundary study parameters are:
- Neurobiomechanical analysis, to measure joint torque patterns.
- Adaptation capability, measured by sensors in LOPES
Background summary
Task specific and intensive training of repetitive active movements results in
the largest functional improvements in the rehabilitation of stroke patients.
Providing this kind of therapy for gait training puts a high physical burden on
therapists. For instance, in gait training on a treadmill with partial
bodyweight usually 2 therapists are needed to assist the patient in walking.
Recently, a new robot device, LOPES, has been developed which can provide
stroke patients with the necessary support in gait training. In LOPES, the
amount of support during walking can be adjusted, varying from high
(robot-in-charge mode) to zero (patient-in-charge mode). Apart of being used as
a training device, LOPES can be used as an evaluation device. The evaluations
can be used to assess the effect of training, but possibly also to predict the
outcome. In this study, we will make a first step in using LOPES as a training
and evaluation device.
Study objective
Primary:
- What are the effects of gait training with the gait rehabilitation device
LOPES on the quality and ability of walking in chronic stroke patients with a
stiff-knee gait?
- What are the effects of two different training modes in the gait
rehabilitation device LOPES, using selective support to improve knee flexion,
or using minimal support?
Secondary:
- Which abnormal joint torque patterns, measured in LOPES, are present in
chronic stroke subjects with a stiff knee gait, compared to age and sex matched
healthy controls.
- Can the ability of subjects to adapt their walking pattern to the provided
support of LOPES be used to predict who will benefit from the LOPES gait
training?
Study design
A double blind, randomized training study. Two training modes of LOPES will be
used: 1) selective support to improve knee flexion during swing phase 2)
minimal support to allow walking in the own gait pattern, including
compensatory movements. Healthy controls are included to provide a framework of
reference data.
Intervention
Stroke subject will perform a gait training program in LOPES of 3 sessions per
week (maximal 45 minutes per session), for a total of 6 weeks. Two training
modes will be used, which will be randomized over the subjects and blinded for
the subjects and assessor. To evaluate the effects of the training program,
subjects will be measured before the start of the training, after 3 weeks of
training and immediately after the end of the training. Follow-up measurements
will be performed 12 weeks after the end of the training program. Healthy age
and sex matched controls are measured once, to provide for reference data.
Study burden and risks
The gait training program with LOPES aims at improving walking. During the
program subjects will be training 3 times per week, for a total period of 6
weeks. Subjects will be measured several times: before the start of the
training program, after the first 3 weeks of training, after the second 3 weeks
of training, and 12 weeks after finishing the program. Healthy controls will be
measured once. The safety of using the LOPES device is tested. Subjects can
take rest during the training and between the measurements to prevent fatigue.
A physiotherapist will accompany the subjects during all tests and training
sessions.
Roessingsbleekweg 33b
7522 AH Enschede
Nederland
Roessingsbleekweg 33b
7522 AH Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Patienten:
- age > 18 years
- first unilateral stroke
- time since stroke > 6 months
- have received treatment at the Roessingh Rehabilitation Centre, but do not receive any outpatient or home therapy targeting the lower limbs anymore
- impaired knee flexion during swing phases (<30 degrees)
- have impairment of the lower extremity (Motricity Index lower extremity < 75)
- independent walkers (FAC 3-4 and higher)
- able to walk for 2 minutes without a break
- show a walking pattern characterized by a forward placement of the paretic foot which is larger than the forward placement of the non-paretic foot
- sufficient cognitive abilities (MMSE >= 22)
- sufficient communication abilities (UCO >= 3)
Controles:
- age > 18 years
- no physical conditions or medication that could affect walking
Exclusion criteria
Patients:
- other physical conditions negatively influencing walking
- have multiple strokes
- no propriocepions in the affected leg
- no contractures limiting the range of motion
- bodyweight > 100 kg
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
---|---|
CCMO | NL23242.080.08 |