Cerebral PalsyNCT04759677
Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy
A study testing Exercise with active video games in people with Cerebral Palsy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. . Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Exercise with active video games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 May 2021
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- must be at I-III level according to the Gross Motor Function Classification System (GMFCS)
- must be able to cooperate during assessments and exercise sessions
- must have sufficient functional dexterity to grasp the Nintendo Wii remote control
Who cannot join
- having excessive upper extremity spasticity that can interfere with movements while playing
- playing Nintendo Wii before
- genetic or neurological disease other than CP diagnosis and epilepsy
- having had muscle-tendon and bone surgery less than 6 months ago
- use of any pharmacological agent to inhibit spasticity less than 6 months ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Energy Expenditure And Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy: Hip Versus Wrist Accelerometer Data
The purpose of this study is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. .
All 20 individuals with CP will participate in a total of 2 exercise sessions on consecutive days with 45 minutes of active video games. In two exercise season individuals will play 4 games that were previously determined and experienced for about 45 minutes. During the training sessions, exercise intensity will be evaluated with the accelerometer.
Read more
The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
Exercise intensity will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the interventions.
For both intervention sessions, a statistical comparison will made between groups in terms of energy consumption, activity counts, and active duration.
Read the detailed description
More validation studies are needed to document the most appropriate place (wrist or waist) to capture limb movement and / or energy consumption (capturing) during physical activity in children with CP at different functional levels. Such information has the potential to guide interventions to improve daily activity throughout life, with potential implications for participation and quality of life.
The purpose of this study is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. Thus, it is thought that reaching the targeted physical activity intensity with active video games in individuals with CP in the clinic can be evaluated with an appropriate and accurate accelerometer placement.
Functional levels of individuals will be determined according to GMFCS. All 20 individuals with CP will participate in a total of 2 exercise sessions with on consecutive days with 45 minutes of active video games. In two exercise season individuals will play 4 games that were previously determined and experienced for about 45 minutes. During the training sessions, exercise intensity will be evaluated with the accelerometer.
The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
Exercise intensity (energy consumption (MET), activity counts, active time during session) will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the interventions. After the measurements were over, the accelerometer data will be loaded on a personal computer and manipulated in ActiLife software version 6.13.3.
For both intervention sessions, a statistical comparison will made between groups in terms of energy consumption, activity counts, and active duration. Statistical analysis will be performed using SPSSc 22.00 package program. Number and percentage will be used for demographic data, mean ± standard deviation notation and descriptive data. In the dependent variables, inter-measurement changes will be evaluated with Wilcoxon test, inter-measurement changes in independent variables will be evaluated by Mann Whitney U test.
- Conditions
- Cerebral Palsy
- Being tested
- Exercise with active video games
- Keywords
- energy expenditure, exercise intensity, video games
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with active video gamesOther
45-minute exercise in which individuals played pre-selected games from Nintendo Wii while keeping in mind their functional level, skills and needs. Four Nintendo Wii games were chosen: Island Cycling, Tilt Table Balance Board, Soccer Heading and Boxing. Each and every individual played these given four games consecutively in one session.
| Study group | Role | What they receive |
|---|---|---|
| the situation where the accelerometer is placed on the wrist during active video games playing | Active comparator | In one session the accelerometer will place on the dominant wrist Individuals will instructed not to remove and instruct them to wear the device during the session. Receives: Other: Exercise with active video games |
| the situation where the accelerometer is placed on the hip during active video games playing | Active comparator | In one session the accelerometer will place on a flexible belt by attaching to the hip area at the intersection of the dominant wrist and axillary line.
Individuals will instructed not to remove and instruct them to wear the device during the session. Receives: Other: Exercise with active video games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy consumption (MET) Exercise Intensity
Energy consumption will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Measured: up to 2 days
Activity counts
Activity counts will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Measured: up to 2 days
Active time
Active time will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Apr 2021
- Study completion1 May 2021
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.
- More trials run by Medipol UniversityThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All 20 individuals with CP will participate in a total of 2 exercise sessions on consecutive days with 45 minutes of active video games. During the training sessions, exercise intensity will be evaluated with the accelerometer. The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Ciddi, Medipol University
- Investigators
- Pınar Kaya Ciddi, Principal investigator, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759677
- Sponsor's protocol ID
- E-10840098-772.02-2683
- Status last verified
- May 2021
- First submitted
- 10 Feb 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure And Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy: Hip Versus Wrist Accelerometer Data
- ClinicalTrials.gov ID
- NCT04759677
- Acronym / sponsor ID
- E-10840098-772.02-2683
- Conditions
- Cerebral Palsy
- Keywords
- energy expenditure, exercise intensity, video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 18 Feb 2021 (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 is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. .
All 20 individuals with CP will participate in a total of 2 exercise sessions on consecutive days with 45 minutes of active video games. In two exercise season individuals will play 4 games that were previously determined and experienced for about 45 minutes. During the training sessions, exercise intensity will be evaluated with the accelerometer.
The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
Exercise intensity will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the interventions.
For both intervention sessions, a statistical comparison will made between groups in terms of energy consumption, activity counts, and active duration.
Detailed description
More validation studies are needed to document the most appropriate place (wrist or waist) to capture limb movement and / or energy consumption (capturing) during physical activity in children with CP at different functional levels. Such information has the potential to guide interventions to improve daily activity throughout life, with potential implications for participation and quality of life.
The purpose of this study is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. Thus, it is thought that reaching the targeted physical activity intensity with active video games in individuals with CP in the clinic can be evaluated with an appropriate and accurate accelerometer placement.
Functional levels of individuals will be determined according to GMFCS. All 20 individuals with CP will participate in a total of 2 exercise sessions with on consecutive days with 45 minutes of active video games. In two exercise season individuals will play 4 games that were previously determined and experienced for about 45 minutes. During the training sessions, exercise intensity will be evaluated with the accelerometer.
The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
Exercise intensity (energy consumption (MET), activity counts, active time during session) will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the interventions. After the measurements were over, the accelerometer data will be loaded on a personal computer and manipulated in ActiLife software version 6.13.3.
For both intervention sessions, a statistical comparison will made between groups in terms of energy consumption, activity counts, and active duration. Statistical analysis will be performed using SPSSc 22.00 package program. Number and percentage will be used for demographic data, mean ± standard deviation notation and descriptive data. In the dependent variables, inter-measurement changes will be evaluated with Wilcoxon test, inter-measurement changes in independent variables will be evaluated by Mann Whitney U test.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All 20 individuals with CP will participate in a total of 2 exercise sessions on consecutive days with 45 minutes of active video games. During the training sessions, exercise intensity will be evaluated with the accelerometer. The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
| Arm | Type | Receives |
|---|---|---|
| the situation where the accelerometer is placed on the wrist during active video games playing | Active comparator | Other: Exercise with active video gamesIn one session the accelerometer will place on the dominant wrist Individuals will instructed not to remove and instruct them to wear the device during the session. |
| the situation where the accelerometer is placed on the hip during active video games playing | Active comparator | Other: Exercise with active video gamesIn one session the accelerometer will place on a flexible belt by attaching to the hip area at the intersection of the dominant wrist and axillary line. Individuals will instructed not to remove and instruct them to wear the device during the session. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- must be at I-III level according to the Gross Motor Function Classification System (GMFCS)
- must be able to cooperate during assessments and exercise sessions
- must have sufficient functional dexterity to grasp the Nintendo Wii remote control
Key exclusion criteria (5 listed)
- having excessive upper extremity spasticity that can interfere with movements while playing
- playing Nintendo Wii before
- genetic or neurological disease other than CP diagnosis and epilepsy
- having had muscle-tendon and bone surgery less than 6 months ago
- use of any pharmacological agent to inhibit spasticity less than 6 months ago
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 |
|---|---|---|
| Exercise with active video games45-minute exercise in which individuals played pre-selected games from Nintendo Wii while keeping in mind their functional level, skills and needs. Four Nintendo Wii games were chosen: Island Cycling, Tilt Table Balance Board, Soccer Heading and Boxing. Each and every individual played these given four games consecutively in one session. | Other | the situation where the accelerometer is placed on the hip during active video games playing, the situation where the accelerometer is placed on the wrist during active video games playing |
Primary outcome
Energy consumption (MET) Exercise Intensity
Time frame: up to 2 days
Energy consumption will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Activity counts
Time frame: up to 2 days
Activity counts will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Active time
Time frame: up to 2 days
Active time will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
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 25 May 2021.
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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.
Pınar Kaya Ciddi principal investigator
İstanbul Medipol 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 Exercise with active video games in people with Cerebral Palsy, run by Medipol University at 1 site 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 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: finished, as of the sponsor's last update on 25 May 2021. 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 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?
Energy consumption (MET) Exercise Intensity (time frame: up to 2 days). The study lists 3 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 25 May 2021.