Cerebral PalsyNCT06493344
The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy
A study testing Applying additional weight in people with Cerebral Palsy and Gait, Spastic, run by University of Thessaly at 1 site in Greece.
Trial summary
The purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Cerebral Palsy, Gait, Spastic, Motor Disorders
- What is being tested?
- Applying additional weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteGreece
- Study dates
- 23 Sep 2021to 23 May 2022
- 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 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The children who participated in the study, aged 12 - 15 years old, were diagnosed with spastic cerebral palsy, level III according to the classification of the GMFCS.
Who cannot join
- From the study, they were excluded:
- children who have received botulinum toxin injection up to 3 months before,
- children who have had selective rhizotomy surgery up to 1 year before,
- children who have a baclofen pump,
- children with uncontrolled epilepsy,
- children with cognitive deficits who cannot follow verbal instructions.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy - University of Thessaly
Lamia, Phthiotis, 35132
About this study
Official title: The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy. Assessment of the Kinematics, Balance and Functional Level
The purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy.
- Being tested
- Applying additional weight
- Keywords
- cerebral palsy, crouch gait, physiotherapy, balance, kinematic analysis
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic, Motor Disorders, Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying additional weightOther
Treadmill training with and without weight (15 minutes of 3 times/ per week for 16 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Spastic Cerebral Palsy Group | Experimental | Conventional physiotherapy and training with applying additional weight Receives: Other: Applying additional weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinovea
Kinovea is a 2D video annotation tool designed for kinematic analysis. Assessment of knee angle during stance phase.
Measured: up to 16 weeks (every 4 weeks)
Gross Motor Function Measure 88 (GMFM-88)
An assessment tool designed and evaluated to measure changes in gross motor function over time in children with cerebral palsy. Unit of Measure: Scoring Options (0, 1, 2, 3, or "not tested") // (higher scores - better outcome)
Measured: up to 16 weeks (every 4 weeks)
Timed Up and Go
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in disabled children. Unit of measure: seconds of completion (higher scores - worse outcomes)
Measured: up to 16 weeks (every 4 weeks)
Sit to Stand (STS) test of the NeuroCom® Balance Master®
A cutting-edge technology used at Balance and Mobility Therapy to accurately assess and treat balance disorders.
Measured: up to 16 weeks (every 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start23 Sep 2021
- Primary completion23 Mar 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Paras, University of Thessaly
- Investigators
- George Paras, Ph.D., Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493344
- Sponsor's protocol ID
- add-weight-CP
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verschuren O, Peterson MD, Balemans AC, Hurvitz EA. Exercise and physical activity recommendations for people with cerebral palsy. Dev Med Child Neurol. 2016 Aug;58(8):798-808. doi: 10.1111/dmcn.13053. Epub 2016 Feb 7.
PubMed 26853808Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
PubMed 34407619
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy. Assessment of the Kinematics, Balance and Functional Level
- ClinicalTrials.gov ID
- NCT06493344
- Acronym / sponsor ID
- add-weight-CP
- Keywords
- cerebral palsy, crouch gait, physiotherapy, balance, kinematic analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 10 Jul 2024 (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 purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic Cerebral Palsy Group | Experimental | Other: Applying additional weightConventional physiotherapy and training with applying additional weight |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The children who participated in the study, aged 12 - 15 years old, were diagnosed with spastic cerebral palsy, level III according to the classification of the GMFCS.
Key exclusion criteria (6 listed)
- children who have received botulinum toxin injection up to 3 months before,
- children who have had selective rhizotomy surgery up to 1 year before,
- children who have a baclofen pump,
- children with uncontrolled epilepsy,
- children with cognitive deficits who cannot follow verbal instructions.
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 |
|---|---|---|
| Applying additional weightTreadmill training with and without weight (15 minutes of 3 times/ per week for 16 weeks). | Other | Spastic Cerebral Palsy Group |
Primary outcome
Kinovea
Time frame: up to 16 weeks (every 4 weeks)
Kinovea is a 2D video annotation tool designed for kinematic analysis. Assessment of knee angle during stance phase.
Gross Motor Function Measure 88 (GMFM-88)
Time frame: up to 16 weeks (every 4 weeks)
An assessment tool designed and evaluated to measure changes in gross motor function over time in children with cerebral palsy. Unit of Measure: Scoring Options (0, 1, 2, 3, or "not tested") // (higher scores - better outcome)
Timed Up and Go
Time frame: up to 16 weeks (every 4 weeks)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in disabled children. Unit of measure: seconds of completion (higher scores - worse outcomes)
Sit to Stand (STS) test of the NeuroCom® Balance Master®
Time frame: up to 16 weeks (every 4 weeks)
A cutting-edge technology used at Balance and Mobility Therapy to accurately assess and treat balance disorders.
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 11 Jul 2024.
- Background: PubMed 26853808Verschuren O, Peterson MD, Balemans AC, Hurvitz EA. Exercise and physical activity recommendations for people with cerebral palsy. Dev Med Child Neurol. 2016 Aug;58(8):798-808. doi: 10.1111/dmcn.13053. Epub 2016 Feb 7.
- Background: PubMed 34407619Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
- 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.
George Paras, Ph.D. principal investigator
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applying additional weight in people with Cerebral Palsy and Gait, Spastic, run by University of Thessaly at 1 site in Greece.
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 1 inclusion and 6 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 11 Jul 2024. 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 Greece. 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?
Kinovea (time frame: up to 16 weeks (every 4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06493344, which also lists 2 linked publications.
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 11 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.