Cerebral Palsy, SpasticNCT03361930
Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk
A study testing Ankle-foot orthosis in people with Cerebral Palsy, Spastic and Hemiplegic Cerebral Palsy, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Hemiplegic Cerebral Palsy
- What is being tested?
- Ankle-foot orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 19 Oct 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital, Rikshospitalet
Oslo, 0424
Ann-Britt Huse, M. Sc., +4799272061, husann@ous-hf.no
Lærke Lindskov, B. Sc., +4790875192, laerli@ous-hf.no
About this study
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
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.
Read more
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.
- Conditions
- Cerebral Palsy, Spastic, Hemiplegic Cerebral Palsy
- Being tested
- Ankle-foot orthosis
- Keywords
- spastic unilateral cerebral palsy, ankle-foot orthosis, AFO, muscle activity, muscular activity, electromyography, EMG,
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-foot orthosisDevice
Also called AFO
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.
| Study group | Role | What they receive |
|---|---|---|
| CP participants | Experimental | 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. Receives: Device: Ankle-foot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Median frequency
Median frequency [uV] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.
Measured: 30 minutes
Root-mean-square (RMS)
RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.
Measured: 30 minutes
Secondary outcomes (2)
Ankle kinematic graph, sagittal plane
Average ankle angle [degrees] for each time interval the gait cycle is divided into.
Measured: 30 minutes
Ankle moment, sagittal plane
Average moment [Nm] value for each time interval the gait cycle is divided into.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start19 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NITO, Norwegian engineering and technology organiziation, Sophies Minde Ortopedi
- Responsible party
- Principal investigator, Ann-Britt Huse, Oslo University Hospital
- Investigators
- Ann-Britt Huse, M. Sc., Principal investigator, Oslo Universety Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361930
- Sponsor's protocol ID
- 2017/161
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03361930
- Acronym / sponsor ID
- 2017/161
- Conditions
- Cerebral Palsy, Spastic, Hemiplegic Cerebral Palsy
- Keywords
- spastic unilateral cerebral palsy, ankle-foot orthosis, AFO, muscle activity, muscular activity, electromyography, EMG,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- NITO, Norwegian engineering and technology organiziation, Sophies Minde Ortopedi
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CP participants | Experimental | Device: Ankle-foot orthosisSingle-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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle-foot orthosisAlso: AFOTwo 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. | Device | CP participants |
Primary outcome
Muscle activity on/off times
Time frame: 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.
Median frequency
Time frame: 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)
Time frame: 30 minutes
RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.
2 secondary outcomes
Ankle kinematic graph, sagittal plane
Time frame: 30 minutes
Ankle moment, sagittal plane
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Britt Huse, M. Sc. principal investigator
Oslo Universety Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle-foot orthosis in people with Cerebral Palsy, Spastic and Hemiplegic Cerebral Palsy, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lærke Lindskov, B. Sc. (+4790875192, laerli@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity on/off times (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.