Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

Electromyographic Comparison of Muscle Activity in Children With Spastic Unilateral Cerebral Palsy During Walking With Two Different Types of Hinged Ankle-foot Orthoses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03361930
• Other study ID #: 2017/161
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 28, 2017
• Start date: October 19, 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Oslo University Hospital
• Contact: Lærke Lindskov, B. Sc.
• Phone: +4790875192
• Email: laerli[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion criteria:

• Spastic unilateral cerebral palsy (hemiplegic)

• Use of an ankle-foot orthosis (AFO) during walking because of equinus in the ankle,

• Excessive plantarflexion during walking

• Gross Motor Function Classification System (GMFCS) I or II

Exclusion criteria:

• Orthopedic surgery on the involved lower limb during the previous 12 months

• Treated with BTX-a in muscles of the involved lower limb during the previous 6 months

• Operated with selective dorsal rhizotomy (SDR)

• Passive dorsiflexion in the ankle, passive extension of the knee and hip < 0 degrees (no fixed contractures)

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Hemiplegic Cerebral Palsy
• Muscle Spasticity
• Paralysis

Intervention

Device:
• Ankle-foot orthosis
Two custom ankle-foot orthoses for the involved lower leg; cast, rectified and fitted by same certified orthotist to reduce clinician variability. The cast is rectified according to the specifications of Hylton (1987) to produce tone-reducing features in the foot plate; the tone-reducing ankle-foot orthosis is manufactured on this cast. The orthotist then remodels the cast with a flat foot plate; the plain ankle-foot orthosis is then manufactured.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	NITO, Norwegian engineering and technology organiziation, Sophies Minde

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle activity on/off times	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.	30 minutes
Primary	Median frequency	Median frequency [uV] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.	30 minutes
Primary	Root-mean-square (RMS)	RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.	30 minutes
Secondary	Ankle kinematic graph, sagittal plane	Average ankle angle [degrees] for each time interval the gait cycle is divided into.	30 minutes
Secondary	Ankle moment, sagittal plane	Average moment [Nm] value for each time interval the gait cycle is divided into.	30 minutes