Children With DisabilitiesDanceDiversityNCT07166055
Feasibility Trial of Family-Centered Therapeutic Dance for Children With Disabilities
A study testing Therapeutic dance in people with Children With Disabilities, run by University of Valencia at 1 site in Spain.
Trial summary
The primary aim of this exploratory cluster-randomized trial is to assess the feasibility and acceptability of delivering a school-based group therapeutic dance program through a family-centered approach for children with disabilities and to generate preliminary estimates of intervention effects and outcome… Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Disabilities
- What is being tested?
- Therapeutic dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2026to Jul 2027
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with motor impairment
- aged between 3-14 years
- who can cognitively follow simple tasks
Who cannot join
- having suffered a serious clinical condition or surgical intervention in the last 6 months.
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
University of Valencia
Valencia, 46010
M.Luz Sánchez-Sánchez, Professor, 0034-963 98 38 55, M.Luz.Sanchez@uv.es
Mireia Fuster Espí, MSD
About this study
Official title: Exploratory Cluster-Randomized Feasibility Trial of a School-Based, Family-Centered Therapeutic Dance Intervention for Children With Disabilities
The primary aim of this exploratory cluster-randomized trial is to assess the feasibility and acceptability of delivering a school-based group therapeutic dance program through a family-centered approach for children with disabilities and to generate preliminary estimates of intervention effects and outcome variability to inform the design of a future definitive cluster-randomized controlled trial.
No confirmatory effectiveness hypothesis is prespecified for this exploratory trial. Instead, the study will estimate the direction, magnitude, and precision of pre-liminary between-group differences in the primary and secondary clinical outcomes and will characterize feasibility and implementation parameters relevant to a future definitive trial.
Read the detailed description
This protocol describes the DanceDiversity trial, an exploratory cluster-randomized feasibility trial designed to evaluate the feasibility and acceptability of a school-based, group therapeutic dance intervention delivered through a family-centered approach for children with disabilities, while generating preliminary estimates of its potential clin-ical effects on individualized occupational performance. Methods: A two-arm, paral-lel-group, assessor-blinded, cluster-randomized feasibility trial will be conducted across 6-10 participating schools. All 10 eligible schools will be invited to participate, with 6 schools representing the anticipated minimum recruitment scenario. Participating schools will be allocated in a 1:1 ratio, using restricted randomization stratified by school type, to either the DanceDiversity experimental group (EG) or a waitlist control group (CG). Approximately 36-60 children with disabilities will be enrolled, depending on the number of participating schools. Baseline assessments will occur prior to alloca-tion disclosure. The EG will receive a 29-week therapeutic dance program consisting of two 60-minute group sessions per week, whereas the CG will maintain usual activities and will be offered the intervention following post-intervention assessment. Outcomes will be evaluated by two blinded independent physical therapists. The primary clinical outcome will be individualized occupational performance, measured by the Canadian Occupational Performance Measure (COPM) performance score. Secondary outcomes assessed in both arms will include the COPM satisfaction score, participation, health-related quality of life, gross motor function, functional mobility, functional bal-ance, walking speed, and passive lower-limb range of motion. Goal Attainment Scaling will be evaluated exclusively within the EG as an exploratory individualized outcome. Prospective feasibility criteria covering recruitment, retention, attendance, and inter-vention fidelity, together with perceived session enjoyment, will also be monitored within the EG.
- Conditions
- Children With Disabilities
- Being tested
- Therapeutic dance
- Keywords
- dance therapy, motor impairment, dance movement therapy, neurological disease
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic danceOther
The protocol includes two sessions per week of therapeutic dance, during the academic year.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in this group will receive DanceDiversity, a manualized, physical therapist-led therapeutic dance intervention delivered over 29 weeks during the academic year (two 60-minute group sessions per week). Receives: Other: Therapeutic dance |
| Control group | No intervention | Participants in the waitlist control group will continue their usual school-based activities throughout the study period and will be invited to receive the therapeutic dance intervention during the subsequent academic cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Canadian Occupational Performance Measure (COPM).
The COPM performance score will be used to assess children's and families' perceptions of performance and satisfaction regarding individualized activity and participation goals. The COPM is a standardized, client-centered, semi-structured interview widely validated in pediatric rehabilitation and designed to identify priorities in meaningful everyday activities. For each identified goal, performance and satisfaction will be rated on a 10-point scale (1 = poor/unsatisfied to 10 = excellent/extremely satisfied). The COPM will be administered as a joint child-caregiver interview rather than through separate self- and proxy-reports.
Measured: Baseline (pre-intervention) and immediately post-intervention.
Secondary outcomes (5)
Quality of life with the Pediatric Quality of Life Inventory (PEDS QL)
A tool used to measure the health-related quality of life in children and adolescents, both with and without health conditions.
Measured: Baseline (pre-intervention) and immediately post-intervention.
Gross Motor Function Measure (GMFM-88).
Is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
Measured: Baseline (pre-intervention) and immediately post-intervention.
Pediatric Balance Scale
The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56.
Measured: Baseline (pre-intervention) and immediately post-intervention.
Timed up and go test (TUG)
This test involves a series of actions that assess an individual's mobility and balance. It requires the individual to rise from a seated position in a standard chair, walk a distance of three meters, turn around, walk back to the chair, and sit down again. The time it takes to complete this sequence is recorded.
Measured: Baseline (pre-intervention) and immediately post-intervention.
Joint ranges
The joint ranges of the hip, knee and ankle in the three planes of movement will be carried out with a goniometer.
Measured: Baseline (pre-intervention) and immediately post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start26 Oct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With DisabilitiesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Therapeutic dance
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166055
- Sponsor's protocol ID
- 2024-FIS-3495976
- Acronym
- DanceDiversity
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data may be shared with other researchers upon a reasonable request made to the project's principal investigator. Study Protocol will be published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Cluster-Randomized Feasibility Trial of a School-Based, Family-Centered Therapeutic Dance Intervention for Children With Disabilities
- ClinicalTrials.gov ID
- NCT07166055
- Acronym / sponsor ID
- DanceDiversity / 2024-FIS-3495976
- Conditions
- Children With Disabilities
- Keywords
- dance therapy, motor impairment, dance movement therapy, neurological disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Sep 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.
The primary aim of this exploratory cluster-randomized trial is to assess the feasibility and acceptability of delivering a school-based group therapeutic dance program through a family-centered approach for children with disabilities and to generate preliminary estimates of intervention effects and outcome variability to inform the design of a future definitive cluster-randomized controlled trial.
No confirmatory effectiveness hypothesis is prespecified for this exploratory trial. Instead, the study will estimate the direction, magnitude, and precision of pre-liminary between-group differences in the primary and secondary clinical outcomes and will characterize feasibility and implementation parameters relevant to a future definitive trial.
Detailed description
This protocol describes the DanceDiversity trial, an exploratory cluster-randomized feasibility trial designed to evaluate the feasibility and acceptability of a school-based, group therapeutic dance intervention delivered through a family-centered approach for children with disabilities, while generating preliminary estimates of its potential clin-ical effects on individualized occupational performance. Methods: A two-arm, paral-lel-group, assessor-blinded, cluster-randomized feasibility trial will be conducted across 6-10 participating schools. All 10 eligible schools will be invited to participate, with 6 schools representing the anticipated minimum recruitment scenario. Participating schools will be allocated in a 1:1 ratio, using restricted randomization stratified by school type, to either the DanceDiversity experimental group (EG) or a waitlist control group (CG). Approximately 36-60 children with disabilities will be enrolled, depending on the number of participating schools. Baseline assessments will occur prior to alloca-tion disclosure. The EG will receive a 29-week therapeutic dance program consisting of two 60-minute group sessions per week, whereas the CG will maintain usual activities and will be offered the intervention following post-intervention assessment. Outcomes will be evaluated by two blinded independent physical therapists. The primary clinical outcome will be individualized occupational performance, measured by the Canadian Occupational Performance Measure (COPM) performance score. Secondary outcomes assessed in both arms will include the COPM satisfaction score, participation, health-related quality of life, gross motor function, functional mobility, functional bal-ance, walking speed, and passive lower-limb range of motion. Goal Attainment Scaling will be evaluated exclusively within the EG as an exploratory individualized outcome. Prospective feasibility criteria covering recruitment, retention, attendance, and inter-vention fidelity, together with perceived session enjoyment, will also be monitored within the EG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Therapeutic dance
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Therapeutic danceParticipants in this group will receive DanceDiversity, a manualized, physical therapist-led therapeutic dance intervention delivered over 29 weeks during the academic year (two 60-minute group sessions per week). |
| Control group | No intervention | –Participants in the waitlist control group will continue their usual school-based activities throughout the study period and will be invited to receive the therapeutic dance intervention during the subsequent academic cycle. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with motor impairment
- aged between 3-14 years
- who can cognitively follow simple tasks
Key exclusion criteria (1 listed)
- having suffered a serious clinical condition or surgical intervention in the last 6 months.
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 |
|---|---|---|
| Therapeutic danceThe protocol includes two sessions per week of therapeutic dance, during the academic year. | Other | Experimental group |
Primary outcome
The Canadian Occupational Performance Measure (COPM).
Time frame: Baseline (pre-intervention) and immediately post-intervention.
The COPM performance score will be used to assess children's and families' perceptions of performance and satisfaction regarding individualized activity and participation goals. The COPM is a standardized, client-centered, semi-structured interview widely validated in pediatric rehabilitation and designed to identify priorities in meaningful everyday activities. For each identified goal, performance and satisfaction will be rated on a 10-point scale (1 = poor/unsatisfied to 10 = excellent/extremely satisfied). The COPM will be administered as a joint child-caregiver interview rather than through separate self- and proxy-reports.
5 secondary outcomes
Quality of life with the Pediatric Quality of Life Inventory (PEDS QL)
Time frame: Baseline (pre-intervention) and immediately post-intervention.
Gross Motor Function Measure (GMFM-88).
Time frame: Baseline (pre-intervention) and immediately post-intervention.
Pediatric Balance Scale
Time frame: Baseline (pre-intervention) and immediately post-intervention.
Timed up and go test (TUG)
Time frame: Baseline (pre-intervention) and immediately post-intervention.
Joint ranges
Time frame: Baseline (pre-intervention) and immediately post-intervention.
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 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized data may be shared with other researchers upon a reasonable request made to the project's principal investigator. Study Protocol will be published.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic dance in people with Children With Disabilities, 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 1 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 15 Oct 2026. 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 (0034 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?
The Canadian Occupational Performance Measure (COPM). (time frame: Baseline (pre-intervention) and immediately post-intervention.). 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 15 Oct 2026.