The main goal of the study is to evaluate the feasibility of using 1) passive treadmill belt speed perturbations to measure spinal reflex activity in the calf muscles; and 2) active real-time visual feedback on dedicated gait parameters to highlight…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter for Objective 1 will be the ankle kinematics,
kinetics, muscle lengths and activity; and for Objective 2 the (in)ability of
children with CP to alter their gait in response to real-time visual feedback
challenging gait modification and improve overall gait, as well as possible
compensations, quantified by changes in hip, knee and ankle kinematics and
kinetics, depending on feedback.
Secondary outcome
NA
Background summary
Clinical gait analysis (CGA) is a useful tool for investigating gait
characteristics in children with spastic paresis, closely associated with
cerebral palsy (CP). Gait is a complex motor task and so understanding the
cause of a specific deviation may be difficult by only observing the patient
while walking at a comfortable level. Rather, additional challenges could be
posed on the patient while walking to enrich the information available from CGA
and allow for better understanding of the underlying gait deviations. Firstly,
treadmill belt accelerations, in which a patient is passively perturbed, could
be used to measure spinal reflex activity. Secondly, by challenging the patient
to actively alter specific aspects of their gait using real-time feedback on
dedicated gait parameters, the ability, or inability, to alter the parameter
may highlight functional impairments and have useful diagnostic inferences.
Study objective
The main goal of the study is to evaluate the feasibility of using 1) passive
treadmill belt speed perturbations to measure spinal reflex activity in the
calf muscles; and 2) active real-time visual feedback on dedicated gait
parameters to highlight functional impairments in children with CP. The overall
objective is to establish if both modifications to CGA provide additional
clinically relevant information.
Study design
Experimental repeated-measures design
Intervention
Perturbations in treadmill speed and real-time feedback of gait parameters
Study burden and risks
The full experiment will take one session of approximately 2 hours. In that
time children will undergo a standard clinical gait analysis on a treadmill
with interactive virtual reality environment, complemented with passive
perturbations as well as different gait modification feedback conditions.
Subjects will undergo a standard physical examination if not available from
clinical practice. The risk of passive perturbations and gait modifications is
negligible, as demonstrated by earlier studies. To protect participants in the
unlikely event of falling, subjects will wear a safety harness during the
walking trials. Total risk of side effects or adverse events during, or after
the assessments and during walking on the treadmill is negligible. Periods of
rest will be allowed between the measurements to prevent fatigue. Patients will
also be made aware that they are free to withdraw from the study at any time
without giving a reason.
De Boelelaan 1118
Amsterdam 1007 MB
NL
De Boelelaan 1118
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
* Children with a diagnosis of uni/bilateral spastic paresis;
* Aged between 5 and 16 years;
* GMFCS level I-II. (gross motor function classification system) (Palisano et al. 1997);
* Sufficient cognitive skills: able to follow simple instructions;
* Good walking ability, i.e. able to follow protocol walking time of 28 minutes. It will be explained to the parents/carers that they must be able to walk on the treadmill for approximately half an hour, with short breaks provided. It is expected that care givers will have a good understanding of the child*s ability and therefore their suitability to take part.
Exclusion criteria
* Functional surgery on bones and/or muscles of the legs or selective dorsal rhizotomy in the last 12 months;
* Lower limbs BoNT A injection in the last 6 months;
* 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
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 | NL56736.029.16 |