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Stretch-REFLEX down-conditIONING using feedback in children with spastic pareses

Stretch-REFLEX down-conditIONING using feedback in children with spastic pareses - Reflexioning

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48808
Enrollment
37
Registered
2019-02-05
Start date
2019-04-24
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral palsy spastic children

Interventions

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

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)