Cerebral PalsyNCT06251531
Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy
A study testing Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) in people with Cerebral Palsy, run by Ruya Gul Temel at 2 sites in Turkey (Türkiye).
Trial summary
Abstract Objective: This study planned to examine the effect of Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (DCP). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Jan 2019to 17 Dec 2020
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The inclusion criteria of the study were a spastic DCP diagnosis, being aged 4-12 years, Gross Motor Function Classification System (GMFCS) level I, II or III, and Manual Ability Classification System (MACS) level I or II, and ability to follow verbal instructions.
Who cannot join
- The exclusion criteria were mental retardation diagnosis, additional treatment other than neurodevelopmental treatment (NDT), surgical intervention or Botulinum Toxin injection in the last six months, diagnosis of psychiatric disorder accompanying CP, vision and/or hearing problems affecting participation.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Rüya Gül Temel
Ankara, Etimesgut, 6145
Rüya Gül Temel
Ankara, 06000
About this study
Official title: The Effect of Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy: A Randomized Controlled Study
Abstract Objective: This study planned to examine the effect of Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (DCP).
Materials and Methods: This study was designed as a randomized controlled trial. 34 children with DCP (14 boys; 20 girls) who received routine therapy included to the study. All children were classified according to the Gross Motor Function Classification System (GMFCS) and the Manual Abilities Classification System (MACS). Participants were randomly divided into two groups: the GD-TG-PBI group (number =17; mean age: 7.70±2.25 years) and the control group (number =17; mean age: 7.41±2.06 years). Both groups received routine therapy twice a week for 45 minutes per session during 8 weeks; while the GD-TG-PBI group received GD-TG-PBI additional to routine therapy twice a week for 45 minutes per session during 8 weeks. Occupational performance and satisfaction were determined with the Canadian Occupational Performance Measure (COPM), and functional performance was evaluated with the Pediatric Evaluation of Disability Inventory (PEDI). The COPM and PEDI were performed before and after the intervention for both groups. Dİfferences between COPM and PEDI values before and after the intervention calculated, additionally the effect size of each parameter calculated.
- Conditions
- Cerebral Palsy
- Being tested
- Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)
- Keywords
- play, child, intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)Other
Also called Goal-Directed Therapist-Guided Play-Based Intervention
The GD-TG-PBI used play to improve performance in targeted functional activities. The program was planned by a physiotherapist with 25 years' experience and an occupational therapist with six years' experience in play. The sessions were based on motor-learning principles supporting cortical plasticity. Individual-specific goals were transformed into play activities that increase occupational participation with regard to the child's abilities, needs, and learning potential. A top-down approach based on direct gamification was adapted without dividing it into components, instead of a component-based, bottom-up approach. Thus, a structured play program was created and an individual-specific intervention was applied in line with the occupational goals and detailed motor evaluations. Positive, active experiences facilitated the adaptation of the learned skills to daily life.
| Study group | Role | What they receive |
|---|---|---|
| GD-TG-PBI | Experimental | Goal-Directed Therapist-Guided Play-Based Intervention Receives: Other: Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) |
| Control Group | No intervention | Routine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Canadian Occupational Performance Measure (COPM)
It was used to identify children's occupational problems and determine the goals of play. The COPM is a patient-reported, semi-structured assessment for individuals aged 8 years and over; it is used for goal-setting and planning interventions (18). The participants who were older than 8 years were asked to answer by themselves, and participants who were under 8 years answered both by themselves and parent proxy to identify and score occupational performance problems experienced in self-care, productivity, and leisure. In comparing initial and final values, a change of at least 2 points indicates clinical significance (19,20). The Turkish validity and reliability was established by Torpil et al (20).
Measured: 30 minutes
Pediatric Evaluation of Disability Inventory (PEDI)
It was used to evaluate functional performance and disability level.PEDI contains 3 scales : Functional Skills Scale (FSS) that identifies clinical patterns of current skills in functional skill attainment; Caregiver Assistance Scale that indirectly measures capability and evaluates actual performance by assesing the extent of help a parent provides in daily functioning, and Modifications scale which was not used in current study. The FSS consists of self-care, mobility, and social function, including the ICF's activity and participation. It consist 197 items in total devided as 73 items in self care, 59 items in mobility and 65 items in social function. Each item is scored as unable (0) or able (1). The caregiver assistance scale measures the caregiver support with a Likert-type rating (0-5). PEDI is sensitive to show clinical changes that can guide the therapist in defining the functional level of children with CP (21-22). The Turkish validity and reliability was established (22).
Measured: 30 minutes
Gross Motor Function Classification System (GMFCS)
The GMFCS was used for classify motor functions of participants. The GMFCS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish GMFCS is valid and reliable.
Measured: 15 minutes
Manual Ability Classification System (MACS)
The MACS was used for classify manuel functions of participants. The MACS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish MACS is valid and reliable.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start18 Jan 2019
- Primary completion20 Jun 2019
- Study completion17 Dec 2020
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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruya Gul Temel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruya Gul Temel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251531
- Sponsor's protocol ID
- Ergo.21269652
- Status last verified
- Feb 2024
- First submitted
- 6 Dec 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06251531
- Acronym / sponsor ID
- Ergo.21269652
- Conditions
- Cerebral Palsy
- Keywords
- play, child, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ruya Gul TemelUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 9 Feb 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.
Abstract Objective: This study planned to examine the effect of Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (DCP).
Materials and Methods: This study was designed as a randomized controlled trial. 34 children with DCP (14 boys; 20 girls) who received routine therapy included to the study. All children were classified according to the Gross Motor Function Classification System (GMFCS) and the Manual Abilities Classification System (MACS). Participants were randomly divided into two groups: the GD-TG-PBI group (number =17; mean age: 7.70±2.25 years) and the control group (number =17; mean age: 7.41±2.06 years). Both groups received routine therapy twice a week for 45 minutes per session during 8 weeks; while the GD-TG-PBI group received GD-TG-PBI additional to routine therapy twice a week for 45 minutes per session during 8 weeks. Occupational performance and satisfaction were determined with the Canadian Occupational Performance Measure (COPM), and functional performance was evaluated with the Pediatric Evaluation of Disability Inventory (PEDI). The COPM and PEDI were performed before and after the intervention for both groups. Dİfferences between COPM and PEDI values before and after the intervention calculated, additionally the effect size of each parameter calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GD-TG-PBI | Experimental | Other: Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)Goal-Directed Therapist-Guided Play-Based Intervention |
| Control Group | No intervention | –Routine therapy |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria of the study were a spastic DCP diagnosis, being aged 4-12 years, Gross Motor Function Classification System (GMFCS) level I, II or III, and Manual Ability Classification System (MACS) level I or II, and ability to follow verbal instructions.
Key exclusion criteria (1 listed)
- The exclusion criteria were mental retardation diagnosis, additional treatment other than neurodevelopmental treatment (NDT), surgical intervention or Botulinum Toxin injection in the last six months, diagnosis of psychiatric disorder accompanying CP, vision and/or hearing problems affecting participation.
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 |
|---|---|---|
| Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)Also: Goal-Directed Therapist-Guided Play-Based InterventionThe GD-TG-PBI used play to improve performance in targeted functional activities. The program was planned by a physiotherapist with 25 years' experience and an occupational therapist with six years' experience in play. The sessions were based on motor-learning principles supporting cortical plasticity. Individual-specific goals were transformed into play activities that increase occupational participation with regard to the child's abilities, needs, and learning potential. A top-down approach based on direct gamification was adapted without dividing it into components, instead of a component-based, bottom-up approach. Thus, a structured play program was created and an individual-specific intervention was applied in line with the occupational goals and detailed motor evaluations. Positive, active experiences facilitated the adaptation of the learned skills to daily life. | Other | GD-TG-PBI |
Primary outcome
The Canadian Occupational Performance Measure (COPM)
Time frame: 30 minutes
It was used to identify children's occupational problems and determine the goals of play. The COPM is a patient-reported, semi-structured assessment for individuals aged 8 years and over; it is used for goal-setting and planning interventions (18). The participants who were older than 8 years were asked to answer by themselves, and participants who were under 8 years answered both by themselves and parent proxy to identify and score occupational performance problems experienced in self-care, productivity, and leisure. In comparing initial and final values, a change of at least 2 points indicates clinical significance (19,20). The Turkish validity and reliability was established by Torpil et al (20).
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 30 minutes
It was used to evaluate functional performance and disability level.PEDI contains 3 scales : Functional Skills Scale (FSS) that identifies clinical patterns of current skills in functional skill attainment; Caregiver Assistance Scale that indirectly measures capability and evaluates actual performance by assesing the extent of help a parent provides in daily functioning, and Modifications scale which was not used in current study. The FSS consists of self-care, mobility, and social function, including the ICF's activity and participation. It consist 197 items in total devided as 73 items in self care, 59 items in mobility and 65 items in social function. Each item is scored as unable (0) or able (1). The caregiver assistance scale measures the caregiver support with a Likert-type rating (0-5). PEDI is sensitive to show clinical changes that can guide the therapist in defining the functional level of children with CP (21-22). The Turkish validity and reliability was established (22).
Gross Motor Function Classification System (GMFCS)
Time frame: 15 minutes
The GMFCS was used for classify motor functions of participants. The GMFCS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish GMFCS is valid and reliable.
Manual Ability Classification System (MACS)
Time frame: 15 minutes
The MACS was used for classify manuel functions of participants. The MACS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish MACS is valid and reliable.
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 9 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) in people with Cerebral Palsy, run by Ruya Gul Temel at 2 sites in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The Canadian Occupational Performance Measure (COPM) (time frame: 30 minutes). 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?
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 9 Feb 2024.