Cerebral PalsyFESCA_CPNCT06820398
Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy
A study testing Functional exercise with progressive strength and resistance load and Functional exercises without any load in people with Cerebral Palsy, run by University of Valencia at 1 site in Spain.
Trial summary
This research project aims to evaluate the benefits of a functional exercise program with strength and resistance load in adolescents with cerebral palsy (CP), specifically classifiedat levels III and IV of the Gross Motor Function Classification System (GMFCS) scale. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Functional exercise with progressive strength and resistance load and Functional exercises without any load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 10 to 18 years.
- Diagnosis of spastic cerebral palsy (CP).
- Classification at levels III or IV of the GMFCS scale.
Who cannot join
- Multilevel surgery with osteotomy within the last 12 months.
- Microtenotomies or percutaneous needle lengthening (APAI) within the last 9months.
- Botulinum toxin injections within the last 3 months.
- Participation in specific strength training protocols.
- Lack of cognitive ability to perform the intervention protocol activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy. University of Valencia
Valencia, 46010
M.Luz Sánchez-Sánchez, PhD, 963983853, m.luz.sanchez@uv.es
Sergio Muñoz-Beato, MSc
About this study
Official title: Effects of Functional Exercise Program With Strength Load and Resistance in Gross Motor Function, Quality of Life and Participation in Children and Adolescents With Cerebral Palsy Levels III-IV GMFCS
This research project aims to evaluate the benefits of a functional exercise program with strength and resistance load in adolescents with cerebral palsy (CP), specifically classifiedat levels III and IV of the Gross Motor Function Classification System (GMFCS) scale. Participants will be included into control or intervention group in this randomized controlled trial. Changes in functional percentile, quality of life, and participation in daily environments will be analyzed based on scores obtained with validated assesment scales.
The study will be conducted at the Children's Neurorehabilitation Unit of Hospitalarias Foundation in Valencia, with an 18-week intervention plus a 6-month follow-up. This project seeks to provide evidence on rehabilitation strategies that promote autonomy and social inclusion for this population.
Read the detailed description
This research project is a randomized controlled trial designed to analyze the effects of a functional exercise program with strength and resistance load in adolescents with CP specifically classified at levels III and IV of the GMFCS scale. The study will include around 40 participants aged 10 to 18 years, randomly assigned to either an intervention group or a control group. The intervention group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. The control group will perform the same functional exercises but without any load.
The protocol includes 36 sessions over 18 weeks, with evaluations at three key time points: before the intervention, at the end of the protocol, and six months post-intervention. The primary outcomes include functional percentile within the GMFCS, quality of life asperceived by patients and caregivers, and participation in daily environments.
The study will adhere to CONSORT guidelines and the Declaration of Helsinki and has been reviewed by an ethics committee.
- Conditions
- Cerebral Palsy
- Being tested
- Functional exercise with progressive strength and resistance load, Functional exercises without any load
- Keywords
- Functional Exercise, Strength, Resistance, Children, Adolescents
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional exercise with progressive strength and resistance loadOther
This group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate.
Functional exercises without any loadOther
This group will perform functional exercises, without strength or resistance load
| Study group | Role | What they receive |
|---|---|---|
| Functional exercise with progressive strength and resistance load | Experimental | This group will perform functionalexercises with progressive strengthand resistance load, adjusted basedon heart rate. Receives: Other: Functional exercise with progressive strength and resistance load |
| Functional exercises without any load | Active comparator | This group will perform functionalexercises without strength orresistance load. Receives: Other: Functional exercises without any load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Percentile Based on Gross Motor Function Classification System (GMFCS)
This variable represents the functional percentile calculated using the Gross Motor Function Classification System (GMFCS) and related measures. It incorporates: 1)GMFCS: A five-level system classifying gross motor movement capacity; 2) GrossMotor Function Measure (GMFM-66 and GMFM-88): Tools for evaluating grossmotor function across multiple dimensions; and 3) GMAE-2 Software: Generatesfunctional percentiles based on GMFM data. Values range from 0 to 100, where 0 represents the lowest functional percentile and 100 the highest.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Secondary outcomes (3)
Quality of Life Assessed with CP-QOL Questionnaire
This variable evaluates the quality of life of caregivers and adolescents using theCerebral Palsy Quality of Life Questionnaire (CP-QOL). The questionnaireassesses multiple domains of well-being and quality of life related to cerebral palsy.Values depend on the raw or normalized scores, which may vary depending on thescoring method. If normalized, scores range from 0 (lowest quality of life) to 100(highest quality of life).
Measured: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Participation in Daily Environments Assessed with PEM-CY
This variable measures the participation of children and adolescents aged 5-18years in daily environments using the Participation and Environment Measure forChildren and Youth (PEM-CY). The PEM-CY evaluates both the frequency ofparticipation in various activities and the impact of environmental factors. Valuesare reported on scales specific to PEM-CY domains, where higher scores indicategreater participation and/or better environmental support.
Measured: Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).
Baseline Heart Rate
This variable represents the baseline heart rate, measured in beats per minute(bpm). It is recorded under resting conditions prior to any intervention or physicalactivity. Values range from 40 to 120 bpm, where lower values are associated withgreater tolerance to exercise.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start31 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M Luz Sanchez, University of Valencia
- Investigators
- M.Luz Sánchez-Sánchez, PhD, Study director, University of ValenciaJuan Francisco Lison Párraga, PhD, Study director, Cardenal Herrera UniversityMaría Dolores Arguisuelas Martínez, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820398
- Sponsor's protocol ID
- 3498583
- Acronym
- FESCA_CP
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Exercise Program With Strength Load and Resistance in Gross Motor Function, Quality of Life and Participation in Children and Adolescents With Cerebral Palsy Levels III-IV GMFCS
- ClinicalTrials.gov ID
- NCT06820398
- Acronym / sponsor ID
- FESCA_CP / 3498583
- Conditions
- Cerebral Palsy
- Keywords
- Functional Exercise, Strength, Resistance, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Feb 2025 (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.
This research project aims to evaluate the benefits of a functional exercise program with strength and resistance load in adolescents with cerebral palsy (CP), specifically classifiedat levels III and IV of the Gross Motor Function Classification System (GMFCS) scale. Participants will be included into control or intervention group in this randomized controlled trial. Changes in functional percentile, quality of life, and participation in daily environments will be analyzed based on scores obtained with validated assesment scales.
The study will be conducted at the Children's Neurorehabilitation Unit of Hospitalarias Foundation in Valencia, with an 18-week intervention plus a 6-month follow-up. This project seeks to provide evidence on rehabilitation strategies that promote autonomy and social inclusion for this population.
Detailed description
This research project is a randomized controlled trial designed to analyze the effects of a functional exercise program with strength and resistance load in adolescents with CP specifically classified at levels III and IV of the GMFCS scale. The study will include around 40 participants aged 10 to 18 years, randomly assigned to either an intervention group or a control group. The intervention group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. The control group will perform the same functional exercises but without any load.
The protocol includes 36 sessions over 18 weeks, with evaluations at three key time points: before the intervention, at the end of the protocol, and six months post-intervention. The primary outcomes include functional percentile within the GMFCS, quality of life asperceived by patients and caregivers, and participation in daily environments.
The study will adhere to CONSORT guidelines and the Declaration of Helsinki and has been reviewed by an ethics committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional exercise with progressive strength and resistance load | Experimental | Other: Functional exercise with progressive strength and resistance loadThis group will perform functionalexercises with progressive strengthand resistance load, adjusted basedon heart rate. |
| Functional exercises without any load | Active comparator | Other: Functional exercises without any loadThis group will perform functionalexercises without strength orresistance load. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents aged 10 to 18 years.
- Diagnosis of spastic cerebral palsy (CP).
- Classification at levels III or IV of the GMFCS scale.
Key exclusion criteria (5 listed)
- Multilevel surgery with osteotomy within the last 12 months.
- Microtenotomies or percutaneous needle lengthening (APAI) within the last 9months.
- Botulinum toxin injections within the last 3 months.
- Participation in specific strength training protocols.
- Lack of cognitive ability to perform the intervention protocol activities.
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 |
|---|---|---|
| Functional exercise with progressive strength and resistance loadThis group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. | Other | Functional exercise with progressive strength and resistance load |
| Functional exercises without any loadThis group will perform functional exercises, without strength or resistance load | Other | Functional exercises without any load |
Primary outcome
Functional Percentile Based on Gross Motor Function Classification System (GMFCS)
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
This variable represents the functional percentile calculated using the Gross Motor Function Classification System (GMFCS) and related measures. It incorporates: 1)GMFCS: A five-level system classifying gross motor movement capacity; 2) GrossMotor Function Measure (GMFM-66 and GMFM-88): Tools for evaluating grossmotor function across multiple dimensions; and 3) GMAE-2 Software: Generatesfunctional percentiles based on GMFM data. Values range from 0 to 100, where 0 represents the lowest functional percentile and 100 the highest.
3 secondary outcomes
Quality of Life Assessed with CP-QOL Questionnaire
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Participation in Daily Environments Assessed with PEM-CY
Time frame: Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).
Baseline Heart Rate
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
M.Luz Sánchez-Sánchez, PhD study director
University of Valencia
Juan Francisco Lison Párraga, PhD study director
Cardenal Herrera University
María Dolores Arguisuelas Martínez, PhD study director
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional exercise with progressive strength and resistance load and Functional exercises without any load in people with Cerebral Palsy, run by University of Valencia at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M.Luz Sánchez-Sánchez, PhD (963983853, m.luz.sanchez@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Percentile Based on Gross Motor Function Classification System (GMFCS) (time frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).). 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 11 Feb 2025.