Cerebral PalsyNCT04802655
Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality
A study testing Video-game based exercise - Exergame and Activity Based Exercise Group (AG) in people with Cerebral Palsy, run by Ahmet Emir at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase randomized controlled trial has planned to conduct. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Video-game based exercise - Exergame and Activity Based Exercise Group (AG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2021to 15 Jul 2023
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with spastic cerebral palsy
- Gross Motor Level should be in between I-III according to Gross Motor Function Classification System (GMFCS)
- Manual ability levels should be in between I-IV according to Manual Abilities Classification System (MACS)
- No Botulinum toxin injections 6 months prior to study
Who cannot join
- Surgery history related to the musculoskeletal system (upper and lower extremities)
- Having communication problems
- Having secondary cognitive-behavioral problems addition to cerebral palsy (intellectual disability)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
The aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase randomized controlled trial has planned to conduct. In the first phase, baseline assessments will be completed for all participants who are eligible to participate. After the baseline assessments, randomisation will be completed for Exergame and Activity Based Exercise groups. During this phase suitable video games for exergame program will be selected. Analytical Hierarchy Process (AHP) will be used to collect expert opinion for most effective video games for upper extremity functionality, postural control, GMFCS I-II-III levels. Second phase of the study will be started afterwards. Upon completing second assessments, interventions for both groups will be conducted. Third assessments will be completed after interventions and outcomes will be analyzed for primary results. The third phase of the study planned as follow-up period. All participant will continue their routine NDT trainings and follow-up assessments will be completed after 3 moths of the second assessments. Final results will be analysed for all participants.
- Conditions
- Cerebral Palsy
- Being tested
- Video-game based exercise - Exergame, Activity Based Exercise Group (AG)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-game based exercise - ExergameOther
Also called Microsoft Xbox One Kinect based exergame program
Selected Kinect compatible video games from Microsoft Xbox one will be applied in this group. Four video games will be selected for a session (each game will last 10 mins). Video games are active video games which participants have to use their body parts in order to control games.
Activity Based Exercise Group (AG)Other
Also called Goal Directed Upper Limb and Postural Control Exercises
Task-oriented exercises to be performed in standing and sitting positions, including upper extremity and trunk, will be applied to the activity-based exercise group in addition to routine NDT training. Examples for activities; stepping and putting stickers on the wall, treading the play dough placed on a step board within one leg stance; reach-grasp activities progressively from sitting to standing, throwing and catching balls on a balance board.
| Study group | Role | What they receive |
|---|---|---|
| Exergame Group (EG) | Experimental | In addition to routine NDT training, Structured Exergame Program for upper extremity and trunk control will be applied in this group. Xbox one - Kinect supported video games will be selected for video-game based exergame program. The Video games to be included in the Exergame program will be selected by Analytical Hierarchy Process. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks. Receives: Other: Video-game based exercise - Exergame |
| Activity Based Exercise Group (AG) | Active comparator | In addition to routine NDT training, Goal Directed Activity Based Exercises for upper extremity and trunk will be applied to this group. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks. Receives: Other: Activity Based Exercise Group (AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Kinematics - Range of Motion Analysis
Upper limb kinematics analysis for range of motion assessments will be conducted via Kinovea 2D motion analysis software. Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist Range of Motion (ROM) values (in degrees) each pivots will be analyzed afterward.
Measured: 10 minutes
Upper Limb Kinematics - Angular velocity
Upper limb kinematics analysis for angular velocity will be conducted via Kinovea 2D motion analysis software.Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist angular velocity (mm/s) of each pivots will be analyzed afterward.
Measured: 10 minutes
Trunk Control Measurement Scale (TCMS)
Trunk Control Measurement Scale (TCMS) is a clinical tool to measure trunk control in children with cerebral palsy. TCMS measures the trunk control in two basic components that are static and dynamic sitting balance. Dynamic sitting balance is divided into two parts as selective movement control and dynamic reaching. The static sitting balance part evaluates trunk control during upper and lower limbs' movements in the sitting position. Balance is assessed during flexion, extension, lateral flexion and rotation movements as selective movements of dynamic sitting. Reaching part of dynamic sitting balance evaluates trunk balance during reaching at different planes. The scale consists of 15 items. Each part has 5,7 and 3 items respectively. Total score ranges between0 and 58 and higher scores reflect better control.
Measured: 15 minutes
Secondary outcomes (3)
Selective Control of Upper Extremity Scale (SCUES)
The SCUES is a video-based assessment tool evaluating upper extremity joint levels, including the shoulder, elbow, forearm, wrist, and fingers. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). Presence of mirror movements, movement of additional joints, and any motion less than available ROM are scored for movement at each joint level. Considering these four common manifestations of impaired SMC, motion at each of the five joint levels is scored on a four-point scale as: no SMC (0 point), moderately diminished SMC (1 point), mildly diminished SMC (2 point), and normal SMC (3 point). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better SMC.
Measured: 15 minutes
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT consists of seven unimanual items that are administered using standardized procedures and verbal instructions and performed first with the nondominant hand and then with the dominant hand. The functional tasks on the JTHFT-IT include (a) writing a 24-letter, third-grade reading difficulty sentence; (b) turning 300-500 (7.62 cm by 12.7 cm) cards in simulated page turning; (c) picking up small common objects (including pennies, paper clips, and bottle caps) and placing them in a container; (d) stacking checkers; (e) simulated feeding; and (f) moving light cans and heavier (1 pound) cans. The subtests are scored by recording with a stopwatch the number of seconds required to complete each task.
Measured: 10 minutes
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
The PEDI-CAT is a comprehensive clinical assessment of functional skills acquired throughout infancy, childhood and adolescence up through the age of 20 years. Each of the four PEDI-CAT domains (daily activities, mobility, social/cognitive and responsibility) is independent and can be used separately or in combination with the other domains. Items in three of the domains focus on the child's ability to perform each functional activity in a manner that is effective given their abilities and challenges. The items in the responsibility domain examine the extent to which responsibility management for complex tasks has been shifted from parent to child. Items do not require the child to perform the activity in a standardized manner for scoring.
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 posted17 Mar 2021
- Study start11 Mar 2021
- Primary completion15 Apr 2023
- Study completion15 Jul 2023
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
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Emir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Emir, Medipol University
- Investigators
- Ahmet Emir, Msc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802655
- Sponsor's protocol ID
- E-10840098-772.02-65173
- Status last verified
- Oct 2023
- First submitted
- 15 Mar 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality
- ClinicalTrials.gov ID
- NCT04802655
- Acronym / sponsor ID
- E-10840098-772.02-65173
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ahmet EmirUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 17 Mar 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 aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase randomized controlled trial has planned to conduct. In the first phase, baseline assessments will be completed for all participants who are eligible to participate. After the baseline assessments, randomisation will be completed for Exergame and Activity Based Exercise groups. During this phase suitable video games for exergame program will be selected. Analytical Hierarchy Process (AHP) will be used to collect expert opinion for most effective video games for upper extremity functionality, postural control, GMFCS I-II-III levels. Second phase of the study will be started afterwards. Upon completing second assessments, interventions for both groups will be conducted. Third assessments will be completed after interventions and outcomes will be analyzed for primary results. The third phase of the study planned as follow-up period. All participant will continue their routine NDT trainings and follow-up assessments will be completed after 3 moths of the second assessments. Final results will be analysed for all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame Group (EG) | Experimental | Other: Video-game based exercise - ExergameIn addition to routine NDT training, Structured Exergame Program for upper extremity and trunk control will be applied in this group. Xbox one - Kinect supported video games will be selected for video-game based exergame program. The Video games to be included in the Exergame program will be selected by Analytical Hierarchy Process. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks. |
| Activity Based Exercise Group (AG) | Active comparator | Other: Activity Based Exercise Group (AG)In addition to routine NDT training, Goal Directed Activity Based Exercises for upper extremity and trunk will be applied to this group. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with spastic cerebral palsy
- Gross Motor Level should be in between I-III according to Gross Motor Function Classification System (GMFCS)
- Manual ability levels should be in between I-IV according to Manual Abilities Classification System (MACS)
- No Botulinum toxin injections 6 months prior to study
Key exclusion criteria (3 listed)
- Surgery history related to the musculoskeletal system (upper and lower extremities)
- Having communication problems
- Having secondary cognitive-behavioral problems addition to cerebral palsy (intellectual disability)
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 |
|---|---|---|
| Video-game based exercise - ExergameAlso: Microsoft Xbox One Kinect based exergame programSelected Kinect compatible video games from Microsoft Xbox one will be applied in this group. Four video games will be selected for a session (each game will last 10 mins). Video games are active video games which participants have to use their body parts in order to control games. | Other | Exergame Group (EG) |
| Activity Based Exercise Group (AG)Also: Goal Directed Upper Limb and Postural Control ExercisesTask-oriented exercises to be performed in standing and sitting positions, including upper extremity and trunk, will be applied to the activity-based exercise group in addition to routine NDT training. Examples for activities; stepping and putting stickers on the wall, treading the play dough placed on a step board within one leg stance; reach-grasp activities progressively from sitting to standing, throwing and catching balls on a balance board. | Other | Activity Based Exercise Group (AG) |
Primary outcome
Upper Limb Kinematics - Range of Motion Analysis
Time frame: 10 minutes
Upper limb kinematics analysis for range of motion assessments will be conducted via Kinovea 2D motion analysis software. Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist Range of Motion (ROM) values (in degrees) each pivots will be analyzed afterward.
Upper Limb Kinematics - Angular velocity
Time frame: 10 minutes
Upper limb kinematics analysis for angular velocity will be conducted via Kinovea 2D motion analysis software.Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist angular velocity (mm/s) of each pivots will be analyzed afterward.
Trunk Control Measurement Scale (TCMS)
Time frame: 15 minutes
Trunk Control Measurement Scale (TCMS) is a clinical tool to measure trunk control in children with cerebral palsy. TCMS measures the trunk control in two basic components that are static and dynamic sitting balance. Dynamic sitting balance is divided into two parts as selective movement control and dynamic reaching. The static sitting balance part evaluates trunk control during upper and lower limbs' movements in the sitting position. Balance is assessed during flexion, extension, lateral flexion and rotation movements as selective movements of dynamic sitting. Reaching part of dynamic sitting balance evaluates trunk balance during reaching at different planes. The scale consists of 15 items. Each part has 5,7 and 3 items respectively. Total score ranges between0 and 58 and higher scores reflect better control.
3 secondary outcomes
Selective Control of Upper Extremity Scale (SCUES)
Time frame: 15 minutes
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: 10 minutes
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
Time frame: 15 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 19 Oct 2023.
- 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.
Ahmet Emir, Msc principal investigator
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 Video-game based exercise - Exergame and Activity Based Exercise Group (AG) in people with Cerebral Palsy, run by Ahmet Emir 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 4 inclusion and 3 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 19 Oct 2023. 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?
Upper Limb Kinematics - Range of Motion Analysis (time frame: 10 minutes). 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 19 Oct 2023.