Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk
- Conditions
- Cerebral Palsy, SpasticHemiplegic Cerebral Palsy
- Interventions
- Device: Ankle-foot orthosis
- Registration Number
- NCT03361930
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The aim of this study is to investigate if ankle-foot orthoses affect changes in muscle activity of children with spastic unilateral cerebral palsy during walking.
To minimize investigator variability, the same orthotist CO, clinical gait analyst GA and physiotherapist PT will perform their designated functions for all participants.
Each subject will be required to attend three appointments.
First appointment: CO takes a lower leg cast of the involved side; the cast is taken with the ankle and hindfoot corrected to neutral position.
Second appointment: CO fits the tone-reducing ankle-foot orthosis which entails trimming the device to fit footwear, checking the orthotic device restricts plantarflexion and ensuring comfortable and functional fit. The device is modified with holes for electrode placement at locations for tibialis anterior and gastrocnemius identified by PT.
The child receives the tone-reducing ankle-foot orthosis and is instructed to use this orthotic device on a daily basis for the next four weeks to grow accustomed to the tone-reducing stimuli which may require some acclimatization.
Third appointment: A clinical examination is conducted by PT. Surface gel electrodes are then attached while the participant is instructed in individual muscle activation tests; SENIAM guidelines will be followed for electrode placement and skin preparation, aside from hamstrings and rectus femoris which will follow amended instructions in line with the scientific literature.
GA quality checks the raw electromyography (EMG) signals by visual inspection during the isolated muscle activation tests and during a dynamic trial for movement artefacts, cross-talk, baseline drift and good noise-to-signal ratio.
Reflective markers are then applied in accordance with Plug-in Gait lower body model by PT to collect kinematic and kinetic data.
A resting trial is collected to establish the baseline activity level for each muscle.
The participant is instructed to walk at a self-selected speed along the walkway. Dynamic trials continue until two clean strikes to the middle force plate are collected for the involved leg. Barefoot data is collected first while any additional modifications necessary for electrode placement are made to the ankle-foot orthoses. The order of the orthotic conditions is randomized.
Data will be recorded confidentially using reference codes for participants and stored on a secure server with designated space allocated by the hospital.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CP participants Ankle-foot orthosis Single-day data collection for walking conditions; barefoot, with plain ankle-foot orthosis (flat foot plate) on involved side, with tone-reducing ankle-foot orthosis on involved side.
- Primary Outcome Measures
Name Time Method Median frequency 30 minutes Median frequency \[uV\] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.
Root-mean-square (RMS) 30 minutes RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.
Muscle activity on/off times 30 minutes Linear electromyography profiles of muscle activity (high-pass filtered, rectified and low-pass enveloped) for medial gastrocnemius, tibialis anterior, medial hamstrings, rectus femoris and vastus lateralis during walking. For each condition, gait cycles from two trials will be averaged. Signals will be synchronized to the gait cycle by foot contact/foot off events and normalized to max dynamic peak. On/off times will be defined as a percentage of max dynamic peak.
- Secondary Outcome Measures
Name Time Method Ankle moment, sagittal plane 30 minutes Average moment \[Nm\] value for each time interval the gait cycle is divided into.
Ankle kinematic graph, sagittal plane 30 minutes Average ankle angle \[degrees\] for each time interval the gait cycle is divided into.
Trial Locations
- Locations (1)
Oslo University Hospital, Rikshospitalet
🇳🇴Oslo, Norway