The aim of the current study is to evaluate a new therapy based on theories regarding mental practice and functional task-oriented training focussing on improvement in arm function outcome in sub acute stroke patients and to study predictors for a…
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Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures for the effect evaluation are upper extremity
functioning on the activity level scored based on:
the Wolf motor Function test (WMFT); Frenchay Arm test (FAT) and based on
accelerometry(ACC).
Secondary outcome
Secondary outcome measures are focussed on both the impairment:
arm section of the Fugl Mayer test (FM)
and the particpation level of the ICF:
Impact on participation and Autonomy questionnaire (IPA), the stroke specific
quality of life (SS-Qol) and the EuroQol 6D (EQ-6D).
Background summary
In the Netherlands, in the year 2000 the incidence of stroke appeared to be
2.2/1000. Over 50 % of patients with an upper limb paresis as a result of
stroke, is confronted with long term impaired arm function and a resulting
disability in daily life performance. Although currently early rehabilitation
treatment in the first phase of stroke is advised in clinical guidelines on
stroke, only little evidence is available on effective rehabilitation treatment
for improving arm hand function in the early phase of stroke. More recently,
mental practice and movement imagery have emerged, specifically targeting
cognitive processes associated with enhancement of motor performance and
specific skilled movement in healthy persons. Training and applying movement
imagery on a regular basis in training and competition is called 'mental
practice'. In sport psychology several studies show that mental practice can be
effective in optimizing the execution of movements in athletes and help
acquisition of new skilled behaviours. Combining mental practice training
principles with active movement training seems beneficial as compared to mental
practice training alone. Mental practice might be used in addition to physical
rehabilitation in patients with neurological disorders and will probably be
most effective in the early stage of recovery, the stage in which the
reorganizing of brain patterns is most prominent.
At this moment, possible benefits of movement imagery as to motor performance
in acute and chronic stroke patients have been investigated in several studies.
In 2006, Braun et al presented a systematic review specifically focussing on
effectiveness of mental practice training in improving upper extremity
functioning and concluded that, based on the included studies, no definite
conclusions could be drawn except that further research, using clear
definitions of the content of mental practice and standardized measurement of
outcome, are needed.
Study objective
The aim of the current study is to evaluate a new therapy based on theories
regarding mental practice and functional task-oriented training focussing on
improvement in arm function outcome in sub acute stroke patients and to study
predictors for a positive treatment result.
It is hypothesized that a 6 weeks mental practice-based training (additional to
'therapy-as-usual'), targeting specific upper extremity skills, important to
the individual patient, will significantly improve both arm function and the
performance of daily activities and will be cost-effective.
Study design
A multi-centre, single-blinded, placebo-controlled randomized controlled multi
center trial will be conducted to evaluate the effects of a 6 weeks mental
practice based treatment on improvement of arm function in patients with an
unilateral stroke. Evaluation of functioning will cover the first year
post-stroke.
Intervention
Patients in the intervention group will receive 'therapy as usual' (in
accordance with the Dutch guidelines for stroke rehabilitation) and additional
mental practice-based arm function training. The mental practice training is
supervised by the occupational therapist of the rehabilitation team. After
baseline measurements are performed, patients in the intervention group will be
familiarised with the mental practice-based therapy. For every patient a
training task tailored to the functional level of the patient, is selected by
the occupational therapist. Five different mental practice training tasks,
derived from the Frenchay Activities Index, are available, with a gradual
increase in complexity. For all tasks a training CDrom containing
video-training material is available to guide the patient during training.
Patients are asked to mentally practice the movement. In case they are able to
actually perform a part of the task, they are allowed to do so, concurrently
with the imagination of the movement. Patients have to practice at least three
times a day during a session of 10 minutes. During the intervention period,
functional progress of the arm/hand is evaluated by the occupational therapist
every two weeks. In case the functional level is improved, a new task will be
chosen and CDroms will be changed. The total intervention takes six weeks.
Patients in the control group receive therapy as usual. In addition, they will
be instructed to practice additional bimanual upper extremity techniques based
on conservative neurodevelopmental (NDT) principles. These exercises are a part
of the usual trainings programme. In clinical practice, training according NDT
principles has been accepted as a conventional therapy. However, recent studies
questioned the additional value of NDT above care as usual in patients with a
stroke. Patients receive a booklet with all tasks presented and are instructed
to practice during 10 minutes at least three times a day. Every two weeks, the
home based training sessions are evaluated by the occupational therapist of the
team.
Total contact-time with the occupational therapist in the intervention and
control group will be equal.
Study burden and risks
There will be no increased risk as compared to the risk of care as usual in
rehabilitation treatment.
zandbergsweg 111 Hoensbroek
6432 CC
NL
zandbergsweg 111 Hoensbroek
6432 CC
NL
Listed location countries
Age
Inclusion criteria
1. first ever stroke
2. post-stroke time of 2 - 6 weeks
3. clinically diagnosed central paresis of the arm/hand with strength MRC grade 1 to
3 of the elbow flexors at entry into the study
4. age between 18 and 85
Exclusion criteria
1. severely impaired cognition
2. severe additional neurological, orthopaedic, rheumatoid impairments prior to
stroke
3. severely impaired communication as to comprehension
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL21365.022.08 |