Gait, SpasticReliabBB-AQMNCT04559776
Reliability of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
A study testing gait analysis in people with Gait, Spastic and Reliability, run by National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu.
Trial summary
gait reliability study of toddlers with typically developing and with unilateral cerebral palsy during the first 6 months of independent walking Read more about this study
- Who is it for?
- Ages 10 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Gait, Spastic, Reliability
- What is being tested?
- gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2016to 31 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 10 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Toddlers from both groups were included in this study if they met the following inclusion criteria:
- up to 3 years of age,
- maximum independent walking experience of 6 months, and
- able to walk 5 metres without falling and with no technical assistance. Regarding the UCP group, one additional inclusion criterion was added: right or left hemiparesis with a typical history of CP (prematurity, before birth stroke, acute foetal distress/ birth hypoxia, brain malformations...).
- Regarding the TD group, two additional inclusion criteria were: typical development and independent gait acquired before the age of 18 months.
- -
Who cannot join
- Toddlers from both groups were excluded in case of
- trauma to the lower limbs in the last 6 months,
- a known skin allergy to any adhesive product, and
- any lower limb surgery. Toddlers in the UCP group were also excluded if they had botulinum toxin injections in the lower limb muscles in the previous 3 months.
- Toddlers in the TD group were also excluded in the presence of a known neurological and/ or orthopaedic disorder.
About this study
Official title: Reliability and Sources of Variability of 3D Kinematics and Muscle Activation Analysis of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
gait reliability study of toddlers with typically developing and with unilateral cerebral palsy during the first 6 months of independent walking
Read the detailed description
This study aim to assess lower limb kinematics and muscle EMG reliability during gait in typically developing toddlers and in toddlers with unilateral cerebral palsy with less than 6 months of independent walking experience and secondary to determine three sources of variability (between subjects, between sessions and between trials) using an optoelectronic system and a surface EMG system. The third aim was to identify the most reliable gait parameters.
This was a cross-sectional study conducted between January 2016 and May 2018 in the Motion Analysis Laboratory of the National Rehabilitation Center for Children (NRCC) "Dr. N. Robanescu", Bucharest (Romania). The toddlers with UCP were recruited among the inpatients and outpatients of the Pediatric Rehabilitation department. TD toddlers were recruited among the siblings of the toddlers with UCP and the children of people known to the investigators. Given the exploratory nature of this study, the target size of each group was set to a minimum of 10 participants per group.Toddlers from both groups were younger than 3 years old and independent walking experience of maximum 6 months. Every child was proposed to be evaluated in two gait analysis sessions within a period of 30 days. The second gait analysis session was planned approximately at 14 days from the first one. The two sessions were performed by the same experienced assessor.
The toddlers walked barefoot at self-selected pace. Each toddler was equipped with 19 reflective markers and 8 surface EMG electrodes. Data was collected with a BTS motion capture system equipped with 8 infrared cameras and 8 channels EMG system. The biomechanical model used was "Helen Hayes with medial markers".The EMG electrodes were positioned according to the SENIAM recommendations over the rectus femoris, the medial hamstrings, the tibialis anterior and the triceps surae.Visual 3D software (C-motion, Rockville, MD, USA) was used to build the kinematic model and identify gait cycles. A qualitative analysis was conducted for each gait cycle and each child in order to exclude the cycles during running or non-straight walking. Data was filtered and normalized. Three sources of variability (between subjects, between sessions and between trials) for kinematics and EMG data were quantified by calculating the standard deviations for each source.Standard Error of Measurement (SEM) for intertrials and intersessions were also calculated. For TD toddlers, a single value was reported as the quadratic mean for the right and left sides.
- Conditions
- Gait, Spastic, Reliability
- Being tested
- gait analysis
- Keywords
- toddlers, 3D motion analysis, EMG, reliability
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysisOther
gait analysis with 3D optoelectronic system and surface EMG
| Study group | Role | What they receive |
|---|---|---|
| typically developing toddlers | Experimental | toddlers with a typical development and with less than 3 years old and less than 6 months of independent walking Receives: Other: gait analysis |
| unilateral cerebral palsy toddlers | Experimental | toddlers with a unilateral cerebral plasy and with less than 3 years old and less than 6 months of independent walking Receives: Other: gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
intertrials and intersessions kinematic reliability
Assess lower limb joint angles reliability during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for each joint of the lower limb and each motion plane and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for joint angles are expressed in degrees.
Measured: 3 years
intertrials and intersessions EMG reliability
Assess lower limb reliability of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.
Measured: 3 years
Secondary outcomes (2)
sources of variability for kinematics
Assess 3 sources of gait variability (intersubjects, intersessions, intertrials) during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience, by calculating the Standard Deviation (SD) for each joint and each motion plane of lower limb joint and in each group of toddlers (TD and UCP). For UCP toddlers, the SD was calculated separately for the affected and the non-affected sides. SD values for joint angles are expressed in degrees.
Measured: 3 years
sources of variability for EMG
Assess 3 sources of gait variability (intersubjects, intersessions, intertrials) of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Deviation (SD) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SD was calculated separately for the affected and the non-affected sides. SD values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start5 Jan 2016
- Primary completion31 May 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, SpasticStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectional study with 2 groups of toddlers (with typical developing and with unilateral cerebral palsy) recorded twice in gait analysis within 30 days interval
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559776
- Sponsor's protocol ID
- 8463/2016
- Acronym
- ReliabBB-AQM
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Sources of Variability of 3D Kinematics and Muscle Activation Analysis of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04559776
- Acronym / sponsor ID
- ReliabBB-AQM / 8463/2016
- Conditions
- Gait, Spastic, Reliability
- Keywords
- toddlers, 3D motion analysis, EMG, reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae RobanescuUniversity, hospital or other
- Collaborators
- University Hospital, Brest
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Sep 2020 (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.
gait reliability study of toddlers with typically developing and with unilateral cerebral palsy during the first 6 months of independent walking
Detailed description
This study aim to assess lower limb kinematics and muscle EMG reliability during gait in typically developing toddlers and in toddlers with unilateral cerebral palsy with less than 6 months of independent walking experience and secondary to determine three sources of variability (between subjects, between sessions and between trials) using an optoelectronic system and a surface EMG system. The third aim was to identify the most reliable gait parameters.
This was a cross-sectional study conducted between January 2016 and May 2018 in the Motion Analysis Laboratory of the National Rehabilitation Center for Children (NRCC) "Dr. N. Robanescu", Bucharest (Romania). The toddlers with UCP were recruited among the inpatients and outpatients of the Pediatric Rehabilitation department. TD toddlers were recruited among the siblings of the toddlers with UCP and the children of people known to the investigators. Given the exploratory nature of this study, the target size of each group was set to a minimum of 10 participants per group.Toddlers from both groups were younger than 3 years old and independent walking experience of maximum 6 months. Every child was proposed to be evaluated in two gait analysis sessions within a period of 30 days. The second gait analysis session was planned approximately at 14 days from the first one. The two sessions were performed by the same experienced assessor.
The toddlers walked barefoot at self-selected pace. Each toddler was equipped with 19 reflective markers and 8 surface EMG electrodes. Data was collected with a BTS motion capture system equipped with 8 infrared cameras and 8 channels EMG system. The biomechanical model used was "Helen Hayes with medial markers".The EMG electrodes were positioned according to the SENIAM recommendations over the rectus femoris, the medial hamstrings, the tibialis anterior and the triceps surae.Visual 3D software (C-motion, Rockville, MD, USA) was used to build the kinematic model and identify gait cycles. A qualitative analysis was conducted for each gait cycle and each child in order to exclude the cycles during running or non-straight walking. Data was filtered and normalized. Three sources of variability (between subjects, between sessions and between trials) for kinematics and EMG data were quantified by calculating the standard deviations for each source.Standard Error of Measurement (SEM) for intertrials and intersessions were also calculated. For TD toddlers, a single value was reported as the quadratic mean for the right and left sides.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cross-sectional study with 2 groups of toddlers (with typical developing and with unilateral cerebral palsy) recorded twice in gait analysis within 30 days interval
| Arm | Type | Receives |
|---|---|---|
| typically developing toddlers | Experimental | Other: gait analysistoddlers with a typical development and with less than 3 years old and less than 6 months of independent walking |
| unilateral cerebral palsy toddlers | Experimental | Other: gait analysistoddlers with a unilateral cerebral plasy and with less than 3 years old and less than 6 months of independent walking |
Who may qualify
- Ages
- 10 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Toddlers from both groups were included in this study if they met the following inclusion criteria:
- up to 3 years of age,
- maximum independent walking experience of 6 months, and
- able to walk 5 metres without falling and with no technical assistance. Regarding the UCP group, one additional inclusion criterion was added: right or left hemiparesis with a typical history of CP (prematurity, before birth stroke, acute foetal distress/ birth hypoxia, brain malformations...).
- Regarding the TD group, two additional inclusion criteria were: typical development and independent gait acquired before the age of 18 months.
Key exclusion criteria (5 listed)
- Toddlers from both groups were excluded in case of
- trauma to the lower limbs in the last 6 months,
- a known skin allergy to any adhesive product, and
- any lower limb surgery. Toddlers in the UCP group were also excluded if they had botulinum toxin injections in the lower limb muscles in the previous 3 months.
- Toddlers in the TD group were also excluded in the presence of a known neurological and/ or orthopaedic disorder.
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 |
|---|---|---|
| gait analysisgait analysis with 3D optoelectronic system and surface EMG | Other | typically developing toddlers, unilateral cerebral palsy toddlers |
Primary outcome
intertrials and intersessions kinematic reliability
Time frame: 3 years
Assess lower limb joint angles reliability during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for each joint of the lower limb and each motion plane and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for joint angles are expressed in degrees.
intertrials and intersessions EMG reliability
Time frame: 3 years
Assess lower limb reliability of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.
2 secondary outcomes
sources of variability for kinematics
Time frame: 3 years
sources of variability for EMG
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing gait analysis in people with Gait, Spastic and Reliability, run by National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intertrials and intersessions kinematic reliability (time frame: 3 years). The study lists 2 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 23 Sep 2020.