Cerebral PalsyFITCPNCT05859360
Functional Exercise Training in Cerebral Palsy: Follow Up
An observational study of Cerebral Palsy, run by University of Basel at 1 site in Switzerland.
Trial summary
The goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (CP) who have been regularly performing high-intensity functional training for almost two years. Read more about this study
- Who is it for?
- Ages 14 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical performance and cardiovascular health measures
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2023to 26 Mar 2024
- Phase
- Observational
- 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 14 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The group adolescents with CP consists of individuals from the CP-FIT pilot study who have both continued or discontinued their training after study completion. Healthy peers are age- and sex-matched able-bodied peers.
Who may be able to join
- CP Individuals:
- Diagnosis of CP.
- Between 14 and 26 years of age.
- Gross Motor Functional Classification System (GMFCS): I-II.
- Cognitive abilities must include: Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend testing and; ability to understand and follow instructions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.
- Healthy peers:
- Between 14 and 26 years of age.
Who cannot join
- CP Individuals:
- Any surgery or botulinum toxin treatment within 6 months prior to the measurements or scheduled during study period. Other medications can be continued as prescribed by the participants' physician.
- Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in physical exercise.
- Uncontrolled seizures or epilepsy.
- Inability to conform to the above mentioned cognitive and physical abilities.
- Healthy peers:
- Diagnosis of congenital heart defects, pulmonary diseases or any neuromuscular disorders or diseases.
- Diagnosis of any acute diseases.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Sport, Exercise and Health, University of Basel
Basel, Canton of Basel-City, 4052
About this study
Official title: Functional Exercise Training With Adolescents and Young Adults With Cerebral Palsy: Follow Up Study
The goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (CP) who have been regularly performing high-intensity functional training for almost two years.
The main research question is: is structured, long-term exercise training able to compensate strength and cardiovascular deficits in adolescents with CP compared to able-bodied peers?
Read the detailed description
The pilot study investigating the effects of a functional exercise training in adolescents and young adults with cerebral palsy (CP) showed increases in strength, power, daily function as well as cardiovascular health. In order to establish the origin of the improvements and its broader effects, we wish to conduct follow-up measurements to the pilot study. These follow-up measurements would establish whether the positive changes in physical performance are due to neural or muscular changes (or both), and shed more light on how therapy should be performed and prescribed in adolescents with CP. Additionally, we wish to measure their aerobic capacity as well as examine their microvascular health. For this cross-sectional analysis, the participants of the CP-FIT Pilot Study who continued to train on a regular basis will be compared to age-matched peers in order to establish whether their strength and fitness deficits compared to peers can be compensated through structured and progressive functional exercise training.
- Conditions
- Cerebral Palsy
- Being tested
- Physical performance and cardiovascular health measures
- Keywords
- functional training, strength, cardiovascular health, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical performance and cardiovascular health measuresOther
- Retinal vessel analysis
- Muscle ultrasound
- Knee extension
- Voluntary activation
- spiroergometry
| Study group | Role | What they receive |
|---|---|---|
| Trained CP | Adolescents and young adults with CP who have continued their regular training after completing the pilot study. Receives: Other: Physical performance and cardiovascular health measures | |
| Untrained CP | Adolescents and young adults with CP who have not continued their regular training after completing the pilot study. Receives: Other: Physical performance and cardiovascular health measures | |
| Trained Peers | Healthy peers who perform high-intensity strength training on a regular basis. Receives: Other: Physical performance and cardiovascular health measures | |
| Untrained Peers | Healthy peers who do not perform high-intensity strength training on a regular basis. Receives: Other: Physical performance and cardiovascular health measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum knee extension force
Maximum force of knee extension in relation to body weight
Measured: 20 minutes
Secondary outcomes (4)
Microvascular health
Static retinal vessel analysis
Measured: 5 minutes
Voluntary activation
Maximum force able to voluntarily activate
Measured: 15 minutes
Spiroergometry
Cardiopulmonary test on bicycle ergometer
Measured: 20 minutes
Muscle architecture
Ultrasound of defined muscle groups
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2023
- Primary completion5 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Minghetti, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859360
- Sponsor's protocol ID
- FITCP: Follow Up
- Acronym
- FITCP
- Status last verified
- Mar 2024
- First submitted
- 4 May 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be made public. Group data will be analysed for publication after study completion.
Publications
Minghetti A, Roth R, Buttiker S, Lichtenstein E, Ritsche P, Keller M. The relationship between exposure to long-term training, neuromuscular function and muscular structure in adolescents with cerebral palsy and typically-developed peers: a cross-sectional follow-up analysis. BMC Musculoskelet Disord. 2026 May 1;27(1):531. doi: 10.1186/s12891-026-09829-3.
PubMed 42067866
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Exercise Training With Adolescents and Young Adults With Cerebral Palsy: Follow Up Study
- ClinicalTrials.gov ID
- NCT05859360
- Acronym / sponsor ID
- FITCP / FITCP: Follow Up
- Conditions
- Cerebral Palsy
- Keywords
- functional training, strength, cardiovascular health, cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 16 May 2023 (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 goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (CP) who have been regularly performing high-intensity functional training for almost two years.
The main research question is: is structured, long-term exercise training able to compensate strength and cardiovascular deficits in adolescents with CP compared to able-bodied peers?
Detailed description
The pilot study investigating the effects of a functional exercise training in adolescents and young adults with cerebral palsy (CP) showed increases in strength, power, daily function as well as cardiovascular health. In order to establish the origin of the improvements and its broader effects, we wish to conduct follow-up measurements to the pilot study. These follow-up measurements would establish whether the positive changes in physical performance are due to neural or muscular changes (or both), and shed more light on how therapy should be performed and prescribed in adolescents with CP. Additionally, we wish to measure their aerobic capacity as well as examine their microvascular health. For this cross-sectional analysis, the participants of the CP-FIT Pilot Study who continued to train on a regular basis will be compared to age-matched peers in order to establish whether their strength and fitness deficits compared to peers can be compensated through structured and progressive functional exercise training.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trained CP | – | Other: Physical performance and cardiovascular health measuresAdolescents and young adults with CP who have continued their regular training after completing the pilot study. |
| Untrained CP | – | Other: Physical performance and cardiovascular health measuresAdolescents and young adults with CP who have not continued their regular training after completing the pilot study. |
| Trained Peers | – | Other: Physical performance and cardiovascular health measuresHealthy peers who perform high-intensity strength training on a regular basis. |
| Untrained Peers | – | Other: Physical performance and cardiovascular health measuresHealthy peers who do not perform high-intensity strength training on a regular basis. |
Who may qualify
- Ages
- 14 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The group adolescents with CP consists of individuals from the CP-FIT pilot study who have both continued or discontinued their training after study completion. Healthy peers are age- and sex-matched able-bodied peers.
Key inclusion criteria (7 listed)
- Diagnosis of CP.
- Between 14 and 26 years of age.
- Gross Motor Functional Classification System (GMFCS): I-II.
- Cognitive abilities must include: Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend testing and; ability to understand and follow instructions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.
- Between 14 and 26 years of age.
Key exclusion criteria (8 listed)
- Any surgery or botulinum toxin treatment within 6 months prior to the measurements or scheduled during study period. Other medications can be continued as prescribed by the participants' physician.
- Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in physical exercise.
- Uncontrolled seizures or epilepsy.
- Inability to conform to the above mentioned cognitive and physical abilities.
- Diagnosis of congenital heart defects, pulmonary diseases or any neuromuscular disorders or diseases.
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 |
|---|---|---|
| Physical performance and cardiovascular health measures* Retinal vessel analysis * Muscle ultrasound * Knee extension * Voluntary activation * spiroergometry | Other | Trained CP, Trained Peers, Untrained CP, Untrained Peers |
Primary outcome
Maximum knee extension force
Time frame: 20 minutes
Maximum force of knee extension in relation to body weight
4 secondary outcomes
Microvascular health
Time frame: 5 minutes
Voluntary activation
Time frame: 15 minutes
Spiroergometry
Time frame: 20 minutes
Muscle architecture
Time frame: 10 minutes
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 27 Mar 2024.
- Derived from this study: PubMed 42067866Minghetti A, Roth R, Buttiker S, Lichtenstein E, Ritsche P, Keller M. The relationship between exposure to long-term training, neuromuscular function and muscular structure in adolescents with cerebral palsy and typically-developed peers: a cross-sectional follow-up analysis. BMC Musculoskelet Disord. 2026 May 1;27(1):531. doi: 10.1186/s12891-026-09829-3.
- Individual participant dataSharing planned: No. No IPD will be made public. Group data will be analysed for publication after study completion.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by University of Basel at 1 site in Switzerland.
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 7 inclusion and 8 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 27 Mar 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 Switzerland. 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?
Maximum knee extension force (time frame: 20 minutes). 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 NCT05859360, which also lists 1 linked publication.
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 27 Mar 2024.