Stroke Clinical Trial
Official title:
Effects of Electromechanical-assisted Gait Training Within an Integrated, Practice-oriented Therapy Approach in Subacute Stroke Patients - a Randomised Controlled (RCT) Trial
Background and Rationale:
Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious
rehabilitation programs 70% of those stroke patients still show limited gait ability after
three months.
Numerous RCTs have shown the superiority of over ground gait training and
electromechanical-assisted gait devices in comparison with conventional over ground gait
training alone. (Jan Mehrholz, Elsner, Werner, Kugler, & Pohl, 2013) However, most of these
trials used the electromechanical-assisted gait devices in a very high frequency which is
almost impossible to achieve in daily clinical routine. Therefore, the effect of a
practice-oriented physical therapy protocol including electromechanical-assisted gait
training remains unclear.
Objective(s):
The aim of this clinical trial is to investigate the effects of an integrated,
practice-orientated individual physical therapy protocol with or without
electromechanical-assisted gait training in subacute stroke patients, respectively.
The effects of both physical therapy protocols will be compared with validated assessments
covering the different components of the ICF framework: function, activity and participation.
Primary objectives: Effects on gait ability and on basic activities of daily living (ADL).
Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle
force, spasticity and reintegration to normal living (RNLI).
Furthermore, different training-related data are recorded to capture the efficiency
(intensity and hassle) of both physical therapy protocols.
Background and Rationale:
Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious
rehabilitation programs 70% of those stroke patients still show limited gait ability after
three months.
Numerous RCTs have shown the superiority of over ground gait training and
electromechanical-assisted gait devices in comparison with conventional over ground gait
training alone. (Jan Mehrholz, Elsner, Werner, Kugler, & Pohl, 2013) However, most of these
trials used the electromechanical-assisted gait devices in a very high frequency which is
almost impossible to achieve in daily clinical routine. Therefore, the effect of a
practice-oriented physical therapy protocol including electromechanical-assisted gait
training remains unclear.
Objective(s):
The aim of this clinical trial is to investigate the effects of an integrated,
practice-orientated individual physical therapy protocol with or without
electromechanical-assisted gait training in subacute stroke patients, respectively.
The effects of both physical therapy protocols will be compared with validated assessments
covering the different components of the ICF framework: function, activity and participation.
Primary objectives: Effects on gait ability and on basic activities of daily living (ADL).
Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle
force, spasticity and reintegration to normal living (RNLI).
Furthermore, different training-related data are recorded to capture the efficiency
(intensity and hassle) of both physical therapy protocols.
Detailed Description:
Background and Rationale:
With 16.9 million people suffered a first stroke and almost six million stroke-related deaths
worldwide in 2010, stroke was ranked as the second most common cause of death at the age of
over 65 years (Lozano et al., 2012). Although mortality-to-incidence ratios have decreased,
the global burden of stroke in terms of the absolute number of people affected every year and
stroke-related deaths are increasing (Krishnamurthi et al., 2013). Taking into account the
demographic changes of our society up to 12 million stroke deaths and 70 million stroke
survivors are expected in 2030 (Krishnamurthi et al., 2013).
In Switzerland 15'000 people suffer a stroke every year (Jorgensen, Nakayama, Raaschou, &
Olsen, 1995). Three months after stroke 20% of the affected patients are still bound to a
wheelchair and 70% show limited gait ability, therefore, the restoration of gait ability is
one of the most important therapy goals. Since motor restoration especially takes place
during the first six months the choice of a proper gait therapy is of great importance
(Jorgensen et al., 1995).
Since repetition and task-specific activity have been shown to be key factors for motor
(re)-learning (Kwakkel, Kollen, & Lindeman, 2004) (French et al., 2007) treadmill training
with body weight support has been implemented in stroke rehabilitation. However, no
superiority of treadmill training compared to conventional over ground gait training could
have been shown to date. Especially patients who cannot walk at all don't seem to benefit
from treadmill training to a greater extent (J Mehrholz et al., 2014). A possible explanation
therefor is the tremendous therapeutic effort needed to move severely impaired patients on a
treadmill. To obtain a higher therapeutic efficiency (reduce therapeutic effort and increased
number of steps) electromechanical-assisted gait devices have been developed. During
electromechanical-assisted gait therapy the patient is either moved by the means of a
robotic-driven exoskeleton orthosis (exoskeleton device) (Colombo, Joerg, Schreier, & Dietz,
2000) or two mechanically driven foot plates simulating the gait pattern (end-effector
device) (Hesse, Sarkodie-Gyan, & Uhlenbrock, 1999).
Over the last decade different studies have evaluated the effect of the implementation of the
exoskeleton and end-effector devices within the rehabilitation process of stroke patients
(Jan Mehrholz et al., 2013). RCTs have shown the superiority of the combination of
conventional over ground gait training supplemented by electromechanical-assisted gait
devices in comparison with conventional over ground gait training alone (Jan Mehrholz et al.,
2013). Especially non-ambulatory patients in the subacute phase (< 3 months after stroke)
benefit from this type of intervention. Furthermore, the choice of the right gait device
matters. A sub analysis showed a statistically significant difference in the recovery of
walking speed in favor of the end-effector compared to exoskeleton devices (Jan Mehrholz et
al., 2013). The largest study ever performed with an end-effector device, "Deutsche
Gangtrainer Studie (DEGAS)" showed that a training program of 20 therapy sessions each
consisting of 20 minutes walking on an end-effector device combined with 25 minutes of
conventional physiotherapy more than doubles the chance of regaining an independent gait
ability compared to the same dosage of conventional physiotherapy alone (Pohl et al., 2007).
Furthermore, the use of electromechanical-assisted gait therapy is safe and does not result
in more adverse events (AE) than conventional physiotherapy (Jan Mehrholz et al., 2013).
Many of the performed RCTs with electromechanical-assisted gait therapy have chosen a high
training intensity of up to five training sessions per week. According to those findings the
German Society for Neurorehabilitation (DGNR) recommends in the so-called S2e-Guidelines
"Rehabilitation der Mobilität nach Schlaganfall (ReMoS)" a training dosage of 500-1000 steps
per day for non-ambulatory stroke patients (Loipl & Wittenberg, 2015). In daily clinical
routine however, it is almost impossible to achieve such a high training intensity due to
limited resources. Thus, it remains unclear whether a realistic therapy program including
around three electromechanical-assisted gait training sessions per week leads to the same
beneficial effects on gait ability. Therefore, the aim of this clinical trial is to
investigate the effects of electromechanical-assisted gait training within an integrated,
practice-orientated physical therapy protocol, which is compared to the effects of the same
amount of physical therapy without electromechanical-assisted gait training in subacute
stroke patients.
Study 0verall Objective:
The aim of this clinical trial is to investigate the effects of an integrated,
practice-orientated individual physical therapy protocol with respectively without
electromechanical-assisted gait training in subacute stroke patients.
Primary Objective:
To compare the effect of both physical therapy protocols with respect to gait ability and
competence in basic ADL.
Secondary Objectives:
To compare the effect of both physical therapy protocols with respect to walking speed,
walking capacity, functional mobility, muscle force, spasticity, and RNLI.
As further objectives, different training-related data are recorded to capture the efficiency
(intensity and hassle) of both physical therapy protocols.
Safety Objectives The risks of this study are kept to a minimum. No specific safety
objectives have been defined.
Primary Study Outcome:
The changes in gait ability and the competence in basic ADL are determined as primary
outcomes. Both are assessed before and after the four-week intervention period (to proof
short term effects) as well as three months after the end of the intevention period (3months
FU).
Gait ability and competence in basic ADL are regarded as to be the most important therapy
goals of subacute stroke patients. Furthermore, these outcomes were also used in other
clinical trials with electromechanical-assisted gait training making results comparable.
Gait ability (ICF-level activity):
To assess gait ability the FAC is performed. The FAC is technically simple, inexpensive,
reliable and sensitive to change in the assessment of patients after stroke who cannot walk
without personal assistance at the beginning of their inpatient rehabilitation. The FAC
provides information about the way of physical (not technical e.g. walking aids, orthosis)
assistance that is needed for walking.
Competence in basic ADL (ICF-level activity):
To assess competence in basic ADL the FIM is performed (ANQ, 2013). The FIM shows an
excellent test-retest-reliability (Hobart et al., 2001), an excellent internal consistency,
excellent criterion validity and high responsiveness (for the motor subscale) in stroke
patients (Jan Mehrholz, Wagner, Rutte, Meißner, & Pohl, 2007). The nurses from ZRW assess the
FIM in every rehabilitation service unit on a weekly basis(Tyson & Connell, 2009). Therefore,
a high level of standardisation is given.
Secondary Outcomes:
The changes in walking speed, walking capacity, muscle force, spasticity, functional mobility
and RNLI are determined as secondary outcomes. All secondary outcomes except RNLI are
assessed before and after the four-week intervention period. RNLI is measured at the 3months
FU.
Walking speed (ICF-level activity):
To assess walking speed the 10mWT is performed. The 10mWT is a simple, highly reliable and
valid test for the assessment of walking speed in stroke patients (Tyson & Connell, 2009). It
is carried out in patients with a FAC-level >=2. Lower FAC-levels are not tested.
Walking capacity (ICF-level activity):
To assess walking capacity the 6minWT is performed. The 6minWT is a simple and valid test
which is used to assess maximum walking distance. It shows adequate reliability and excellent
validity in stroke patients (Kosak & Smith, 2005). The 6minWT is carried out in patients with
FAC-Level >=2. Lower FAC-levels are not tested.
Functional Mobility (ICF-level activity):
For the assessment of mobility, the DEMMI is chosen. The DEMMI consists of 17 basic everyday
mobility tasks differentiating between 5 conditions (bed, chair, static balance, walking and
dynamic balance) (de Morton, Davidson, & Keating, 2008). The DEMMI is a practical, short and
valid mobility test for geriatric and stroke patients that is sensitive to detect changes
(Braun et al., 2015).
Muscular Strength lower extremities (ICF-level structure/function):
Change of lower extremities muscular strength is measured with the Motricity Index (MI). Due
to the present intervention studied only the muscle force of the lower limbs will be
evaluated (hip flexion, knee extension, ankle dorsiflexion). Previous studies have shown that
the MI is a valid, reliable and sensitive tool that is short and easily to apply (Collin &
Wade, 1990; Demeurisse, Demol, & Robaye, 1980).
Spasticity (ICF-level structure/function):
Quantification of spasticity of the affected lower limb is carried out with the mTS. The mTS
has shown to have very good test-retest reliability and sensitivity that is high enough to
measure changes pre-post treatment (Jan Mehrholz et al., 2005).
Reintegration to normal living (ICF-level participation):
For the assessment of the ICF level participation the RNLI is chosen. The instrument can be
used to evaluate the degree to which the patient has been able to return to a normal life
(Wood-Dauphinee & Williams, 1987).
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