Spastic Hemiplegic Cerebral PalsySCPNCT02010736
Loading Gait in Spatic Cerebral Palsy
A study testing Single treadmill gait training with additional loading in people with Spastic Hemiplegic Cerebral Palsy, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to observe the behavior of kinematic variables in children with spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with ankle loading. The children underwent a single treadmill training session with ankle loading. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Single treadmill gait training with additional loading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Nov 2012
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic Hemiparetic Cerebral Palsy;
- Being able to walk without an assistive device (levels I or II of the Gross Motor Function Classification System - GMFCS);
- Not having undergone muscle lengthening surgery within the previous year;
- Not having applied botulin toxin to the lower limbs or serial casting in the previous 6 months.
Who cannot join
- Inability to understand simple commands to perform the training and evaluation;
- Inability to walk on the treadmill with or without load on the lower limbs;
- Presence of any physical pain or discomfort during the course of training.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte, 59072-970
About this study
Official title: Immediate Effects of a Single Treadmill Gait Training Session With Additional Loading on Kinematic Gait Parameters in Children With Spastic Cerebral Palsy
The purpose of this study is to observe the behavior of kinematic variables in children with spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with ankle loading.
The children underwent a single treadmill training session with ankle loading. The kinematic parameters were assessed in three phases: before training (PRE); immediately after training (POST); and 5 minutes after the end of training (FOLLOW UP).
The investigators hypothesized that the treadmill gait training with additional lower limb loading would be a disturbance capable of modifying the locomotor strategy of children with SHCP, by the increase in kinematic parameters in the swing phase of gait.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Single treadmill gait training with additional loading
- Keywords
- Cerebral palsy, Gait, Weight Bearing, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single treadmill gait training with additional loadingOther
| Study group | Role | What they receive |
|---|---|---|
| Spastic Hemiparetic Cerebral Palsy | Experimental | Single treadmill gait training with additional loading Receives: Other: Single treadmill gait training with additional loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in kinematic gait parameters after treadmill trainning with ankles loading
Kinematic gait data were captured by Qualisys Track Manager 1.6.0.x - QTM software and exported to Visual3D processing software, to reconstruct the segments and create a biomechanical model. It was carried out in two stages: static and dynamic collection. The dynamic collection was performed while the children walked on the electric treadmill.
The primary outcome measure was the following spatiotemporal variables at the POST phase: cadence (steps/min), stride length (m), paretic step length (m), stance time (%), swing time (%) paretic lower limb (PLL), double stance (%), symmetry ratio and stance/swing time ratio. With respect to angular variables, the following parameters was analysed: angular displacement (maximum flexion, maximum extension and range of motion) of the hip and knee were investigated (º).
Measured: Immediately after training with ankles loading (POST phase)
Secondary outcomes (1)
Changes in kinematic gait parameters after five minutes of rest
Kinematic gait data were captured by Qualisys Track Manager 1.6.0.x - QTM software and exported to Visual3D processing software, to reconstruct the segments and create a biomechanical model. It was carried out in two stages: static and dynamic collection. The dynamic collection was performed while the children walked on the electric treadmill.
The secundary outcome measure was the same spatiotemporal and angular variables investigated at the POST phase although in this condition they was analysed at FOLLOW UP phase.
Measured: After five minutes of rest (FOLLOW UP phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte
- Investigators
- Camila R Simão, MSc, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010736
- Sponsor's protocol ID
- CEP-UFRN 76519/2012
- Acronym
- SCP
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of a Single Treadmill Gait Training Session With Additional Loading on Kinematic Gait Parameters in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02010736
- Acronym / sponsor ID
- SCP / CEP-UFRN 76519/2012
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- Cerebral palsy, Gait, Weight Bearing, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Dec 2013 (estimated)
- 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 purpose of this study is to observe the behavior of kinematic variables in children with spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with ankle loading.
The children underwent a single treadmill training session with ankle loading. The kinematic parameters were assessed in three phases: before training (PRE); immediately after training (POST); and 5 minutes after the end of training (FOLLOW UP).
The investigators hypothesized that the treadmill gait training with additional lower limb loading would be a disturbance capable of modifying the locomotor strategy of children with SHCP, by the increase in kinematic parameters in the swing phase of gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic Hemiparetic Cerebral Palsy | Experimental | Other: Single treadmill gait training with additional loadingSingle treadmill gait training with additional loading |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Spastic Hemiparetic Cerebral Palsy;
- Being able to walk without an assistive device (levels I or II of the Gross Motor Function Classification System - GMFCS);
- Not having undergone muscle lengthening surgery within the previous year;
- Not having applied botulin toxin to the lower limbs or serial casting in the previous 6 months.
Key exclusion criteria (3 listed)
- Inability to understand simple commands to perform the training and evaluation;
- Inability to walk on the treadmill with or without load on the lower limbs;
- Presence of any physical pain or discomfort during the course of training.
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 |
|---|---|---|
| Single treadmill gait training with additional loading | Other | Spastic Hemiparetic Cerebral Palsy |
Primary outcome
Changes in kinematic gait parameters after treadmill trainning with ankles loading
Time frame: Immediately after training with ankles loading (POST phase)
Kinematic gait data were captured by Qualisys Track Manager 1.6.0.x - QTM software and exported to Visual3D processing software, to reconstruct the segments and create a biomechanical model. It was carried out in two stages: static and dynamic collection. The dynamic collection was performed while the children walked on the electric treadmill. The primary outcome measure was the following spatiotemporal variables at the POST phase: cadence (steps/min), stride length (m), paretic step length (m), stance time (%), swing time (%) paretic lower limb (PLL), double stance (%), symmetry ratio and stance/swing time ratio. With respect to angular variables, the following parameters was analysed: angular displacement (maximum flexion, maximum extension and range of motion) of the hip and knee were investigated (º).
1 secondary outcome
Changes in kinematic gait parameters after five minutes of rest
Time frame: After five minutes of rest (FOLLOW UP phase)
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 16 Dec 2013.
- Cerebral palsyLink provided by the sponsor.
- Gait trainingLink provided by the sponsor.
Related trials for Spastic Hemiplegic Cerebral Palsy
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Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
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Neuro-MoD: Neuroplasticity With Motor Development
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Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
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Implementation of Therapy Together
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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.
Camila R Simão, MSc principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single treadmill gait training with additional loading in people with Spastic Hemiplegic Cerebral Palsy, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 3 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 16 Dec 2013. 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 Brazil. 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?
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?
Changes in kinematic gait parameters after treadmill trainning with ankles loading (time frame: Immediately after training with ankles loading (POST phase)). 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 16 Dec 2013.