The main goal of this study is to test the feasibility of two different operant conditioning methods to decrease hyperreflexia of children with CP/SP/HSP, using real-time visual feedback.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the size of the hyperreflexia of the triceps
surae muscles as measured using a controlled setting with mechanical
perturbations, the dynamic hyperreflexia measured as the triceps surae muscular
response to muscle fiber lengthening during gait and the double bump index of
the triceps surae electromyographic signal before and after visual feedback.
Secondary outcome
To evaluate if sufficient intrinsic motivation can be obtained for children
with CP/HSP/SP during real-time visual feedback, the level of motivation will
be assessed using a translated version of the Intrinsic Motivation Inventory
(IMI).
To evaluate any changes in the gait pattern resulting from EMG feedback during
the functional protocol, several parameters will be analyzed:
• Changes in foot, ankle, knee and hip kinematics.
• Spatiotemporal parameters such as stride length, stride time, stance phase
and step width.
• Changes in ankle, knee and hip kinetics, including negative work at the
ankle, knee and hip (J/kg), positive work at the ankle, knee and hip (J/kg) and
peak power generation at the ankle (W/kg).
• Changes in gait profile score (GPS): The total gait pattern will be described
by the overall gait score as measured by GPS (Baker et al., 2009).
• A series of demographic variables will be obtained including patient history,
brain MRI when available, severity of limitations, used medicines, age, gender,
height and weight in order to describe the population characteristics. When
available, brain MRI will be used to verify the diagnosis of cerebral palsy,
and DNA tests to confirm the diagnosis of HSP.
Background summary
Spastic paresis (SP) is a common motor disorder in children. The most common
cause of SP is cerebral palsy (CP) where a lesion, as diagnosed with MRI, is
visible in the developing brain. In some cases, no abnormalities are seen in an
MRI, but genetic testing reveals a hereditary form of SP (HSP). Over 85% of
children with CP, and all children with HSP, experience spasticity, also
referred to as velocity dependent stretch hyperreflexia. Hyperreflexia can lead
to increased energy cost of walking, as well as limitations in muscle growth.
When hyperreflexia is present, medicines are often used for treatment, but this
has several limitations. Therefore, other methods are necessary to decrease
hyperreflexia. Training programs to decrease hyperreflexia have been developed
and tested in multiple participant groups, but only few studies analyzed this
for children with CP and improvements were either small or reported results
were limited. Small improvements could be enlarged when new insights in motor
learning are incorporated in operant conditioning methods, such as the
importance of easily identifiable goals, functional training and internal
motivation. Therefore, this study will test the feasibility to decrease
hyperreflexia within a single session using two different methods. In both
protocols visual feedback will be provided to children with CP. In one protocol
feedback is given on the reflex activity during a controlled setting, in which
ramp-and-hold perturbations are applied around the ankle joint. The other
protocol provides feedback on muscle activity during a functional activity,
namely gait. Both tests will be performed on children with CP who have
hyperreflexia and experience a deviating gait pattern. This feasibility study
explores the possibilities to achieve improvements within one session and
should lead to a method that can be incorporated in a larger training program
in follow-up studies, to decrease hyperreflexia in children with CP on the long
term and thereby decrease energy cost of walking and allow stretch on the
muscles to enhance muscle growth. Additionally, the effect of commonly applied
clinical treatments will be assessed. If participants are scheduled for
treatments, they will be asked to participate in post-treatment measurements
where we perform the same reflex measures to assess differences.
Study objective
The main goal of this study is to test the feasibility of two different operant
conditioning methods to decrease hyperreflexia of children with CP/SP/HSP,
using real-time visual feedback.
Study design
This is a one-site, single- or double-session, feasibility study using a
within-subject repeated measures design, as well as a between group-design for
the hyperreflexia measure.
Intervention
The applied intervention exist of visual feedback provided in two parts of the
protocol:
In the controlled protocol, feedback is given on the size of the hyperreflexia
as measured using the Dyno 2.0.
In the functional protocol, feedback is given on the pattern of the EMG signal
of the calf muscles as measured during gait.
All children with CP receive the same feedback. The two protocols are presented
in random order.
No typically developing children take part in the intervention part of the
research.
Study burden and risks
The burden and risks are minimal as the measurements are non-invasive, painless
and easy to perform. Furthermore, two feasibility studies are combined to
maximize the research benefits and minimize the burdening of the participant.
Combining the two experiments reduces travel time, placement of measurement
equipment and time spent on clinical tests, which are necessary for both
experiments. Total risk of side effects or adverse events during, or after the
assessments is negligible. Periods of rest will be allowed between the
measurements to prevent fatigue. Participants will also be made aware that they
are free to withdraw from the study at any time without giving a reason. The
participant will not benefit from the results, but they will contribute to the
treatment of CP patients in the future. The study is focused on children with
CP, since they often have multiple negative effects from their hyperreflexia.
Furthermore, children respond differently to training than adults, hence it is
important to analyze the applicability of this method for this participant
group.
De Boelelaan 1117
Amsterdam 1007 MB
NL
De Boelelaan 1117
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
- aged between 6 and 17 years
- Sufficient cognitive skills: able to follow simple instructionsPatients:
- children diagnosed with spastic uni-or bilateral CP/SP/HSP
- hyperreflexia in at least one of the triceps surae muscles
- GMFCS level I-II (gross motor function classification system)rogram
Exclusion criteria
• Functional surgery on bones and/or muscles of the legs in the last 12 months;
• Lower limbs BoNT A injection in the last 6 months;
• Selective dorsal rhizotomy surgery in the past
• Intrathecal baclofenpump
• Shortening of the gastrocnemius (more than 10 degrees plantair flexion
contracture)
• Visual deficit that will hamper with the ability to see or interpret the
visual feedback as assessed by the treating physician at the department;
• Behavioural problems of an extent that may impede normal subject cooperation
as assessed by the treating physician at the department;
• Comorbidities that affect walking, visual or cognitive abilities (e.g.
frequent epilepsy) to an extent that makes subjects unfit to participate as
assessed by the treating physician at the department.
Design
Recruitment
Medical products/devices used
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 | NL65846.029.18 |