Functional gait training as complementary treatment to botulinum toxin type A in patients with disabling dystonia due to Parkinson*s disease: a double-blind randomized controlled clinical trial.

Approximately 6.2 million people worldwide have Parkinson*s disease (PD), with
50.000 people in the Netherlands alone. For a variety of reasons, the number of
people with PD is expected to grow substantially, taking pandemic proportions.
PD can lead to a broad spectrum of symptoms, one of which can be dystonia.
Dystonia is defined as *a movement disorder caused by sustained or intermittent
muscle contractions causing abnormal, often repetitive movement, postures or
both*. Dystonia is thought to be present in 30 percent or more in people with
PD, particularly in people with disease onset at a young age (i.e., before the
age of 40). Dystonia of the foot can cause varus tilt of the hindfoot when
walking and results in pain, risk of an ankle sprain, imbalance and falls.
Treatment with botulinum toxin type A is the current gold standard. It is our
clinical experience that treatment effects of botulinum toxin type A are larger
when this is combined with complementary functional gait training. This has,
however, not been studied. Therefore, we hypothesize that botulinum toxin type
A's treatment effects are more extensive when combined with complementary
functional gait training in people with varus tilt of the hindfoot due to
dystonia in PD.

To investigate whether treatment of dystonia causing varus tilt of the hindfoot
in Parkinson*s disease is more effective when botulinum toxin type A is
combined with complementary functional gait training compared to botulinum
toxin type A treatment without functional training.

This study is a double-blind randomized randomized controlled clinical trial.
Primary outcome measure is the effect on personalized goals (using the Canadian
Occupational Performance Measure (COPM)).

Next to the standard botulinum toxin treatment of varus tilt of the hindfoot,
participants in the intervention group will receive additional daily functional
gait training via home-exercises for 8 weeks. The control group will follow the
same procedure, but with non-functional dance exercises. The treatment with
botulinum toxin is not part of the intervention since this is the standard
treatment.

Benefit: We expect that subjects, both in the control and intervention group,
will benefit from participation in the study since the treatment with botulinum
toxin type A is the gold standard for PD patients with varus tilt of the
hindfoot. Patients will also receive this treatment when not participating in
this study. Additionally, the daily 10-minute functional gait exercises might
be beneficial for the treatment of varus tilt of the hindfoot.
Burden: Subjects are asked to perform daily 10-minute exercises for eight
weeks, and the burden is expected to be negligible.
Risks: We do not expect any potential issues of concern within this project.
Treatment with botulinum toxin is the standard treatment for treating varus
tilt in PD patients with dystonia. The daily exercises do not add any
additional burden or risk to the participant.