Added-value of early post-stroke spasticity reduction during arm-hand rehabilitation treatment on improving functional arm-hand skill performance in sub acute stroke patients with a severely or moderately affected arm-hand

Whereas there is a myriad of literature on the benefits of reducing spasticity
on rehabilitation training effects regarding arm-hand function (AHF) and
arm-hand skill performance (AHSP) in chronic stroke patients using
Botulinumtoxin-A, a review of scientific literature revealed that thus far
little evidence is available on the added-value of early spasticity reduction
during rehabilitation training on the improvement of AHF and AHSP in sub-acute
stroke patients. Clinical experience showed that already in an early, sub-acute
phase post-stroke, in a number of patients with a moderate to severely affected
arm and hand (Utrecht Arm-hand Test (UAT) score 1-3), moderate to severe grades
of spasticity (Modified Ashworth Scale (MAS) scores 1+ to 3) occur that
seriously hinder AHF and AHSP treatment, leading to a slowing down of
functional recovery of the patient. The present study will investigate the
added-value of reduction of early signs of spasticity in the sub-acute phase
after stroke on arm-hand rehabilitation treatment outcome involving a
well-described rehabilitation intervention (*treatment-as-usual*), i.e. CARAS.

The aim of the present study is to investigate the added-value of reduction of
early signs of spasticity in the upper extremity on improving functional
arm-hand skill performance in sub-acute stroke patients with either a severely
or moderately affected arm-hand (Utrechtse Arm-hand Test (UAT) score 1-3) and
moderate to severe grades of spasticity. Therapy-as-usual (TAU), involving a
regular, well-documented, concise arm-hand rehabilitation treatment (called
CARAS) will be provided during each patient*s rehabilitation program. TAU will
include spasticity-reducing treatment using Botulimumtoxin-A (BoNt-A)
injections (as a non-investigational product) in the spastic muscles of the
arm-hand.

The current study features three methodological approaches, i.e.:
i) a (multiple baseline) single case experimental design involving 10
individuals;
ii) a meta-analysis of the data of all single cases (= single arm group design);
iii) a case-matched control design in which each patient receiving early
post-stroke spasticity reduction treatment (next to CARAS) will be matched
(according to arm-hand capacity (ARAT) at baseline, age, gender, UAT score at
baseline and level of spasticity within 5 weeks after the start of CARAS (MAS
score) ) to a case from a previous study called AMUSE (CCMO code:
NL35681.068.11) (= non-randomised double arm group design).

During the so-called 'therapy-as-usual' (TAU), comprising of a well-described
arm-hand excercise / rehabilitation program (called CARAS), spasticity in the
arm muscles on the affected side will be reduced usingt Botulimumtoxin-A
(BoNt-A) injections.

The patient may benefit from this study in that oncoming spasticity in his
arm-hand may be reduced at an early stage, thus enabling him to train his arm
and hand in a more functional way, thereby increasing the chance of reaching a
higher level of functional outcome, enabling him to perform his daily
activities better. As BoNt-A is already used extensively in clinical practice,
this project poses no additional risks. The decision to use BoNt-A is entirely
based on clinical necessity, i.e. when a patients is developing spasticity in
the upper limb on the affected side, as established by the rehabilitation
physician. Also, all measures used in the present study pose no harm to the
participant. They are also used as regular clinimetrics in rehabilitation.