Cerebral PalsyNCT02364245
Evaluation the Feasibility and Effects of Kinect-based Computer Games as UE Training Tool in Cerebral Palsy Children
A study testing Kinect, Traditional OT(30 Mins) and Traditional OT(60 Mins) in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to design and evaluation the feasibility, effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Kinect, Traditional OT(30 Mins) and Traditional OT(60 Mins)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2014to Jul 2016
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Cerebral Palsy
- 4-12 years old
- Cognition ability is good for evaluation and training
- Affected side: Manual ability classification system(MACS) I-III
Who cannot join
- Accept Upper Extremity surgery before recruiting
- Accept Botox injunction three months before recruiting
- Unstable Seizure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung, Taiwan, 833
About this study
Official title: Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children With Cerebral Palsy
The purpose of this study is to design and evaluation the feasibility, effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral Palsy.
Read the detailed description
Background Children with cerebral palsy (CP) usually have various limitations in function of their upper limbs. Upper limbs function training is one of the important issues in CP rehabilitation. There is a growing interest in rehabilitation specialists to integrate commercialized interactive computer play into rehabilitation programs. According to the literature research, commercialized interactive computer play could improve speed and quality of movement, for hand or upper limb function, the results were mixed. The investigators think the interactive computer play could be feasible in upper limb training among children with CP. However, the investigators should integrate the rehabilitation training concept to the computer playing in order to get better outcome from such training. The electronic experts and rehabilitation experts should work together to reach the goal. Therefore, the aims of this study are 1.to design Kinect computer games as the rehabilitation training tool for upper limbs of children with CP, 2. to assess the feasibility and effects of the Kinect computer games.
Methods The investigators will spend around nine months to design the computer games. The investigators will search from the internet to download the computer games which are with no copy-right issue. The investigators will use Kinect sensor to catch the child's motion. The rehabilitation team will choose several upper limb motions which are common used in training for children with CP. Then Professor Chang's team will modify the software design to make those target motions to be the game control actions.When a prototype game is created, the investigators will invite two to four children with CP to pilot test the game. The game design will be completed till children and therapists satisfy the design.
Within one year and three months the investigators will do a randomized control trial to compare the effects between the Kinect games and traditional occupational therapy (OT) in the upper limb function of children in CP. The investigators will recruit 30 children and randomize them into two groups.
In each intervention section the intervention group will receive computer games training for 30 minutes and 30 minutes traditional OT. The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks.
Statistic methods Inter-group differences in baseline characteristics were evaluated using an independent t tests or Wilcoxon rank sum tests or χ2 analysis. Analysis of variance with repeated measures was used to determine the effects of intervention on each dependent variable. Model effects were group, time, and their interaction.
- Conditions
- Cerebral Palsy
- Being tested
- Kinect, Traditional OT(30 Mins), Traditional OT(60 Mins)
- Keywords
- Cerebral Palsy., Upper Extremity, Kinect, Virtual reality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinectDevice
Receive computer games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
Traditional OT(30 Mins)Other
Receive Traditional Occupational Therapy training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
Traditional OT(60 Mins)Other
Receive Traditional Occupational Therapy training for 60 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Kinect | Experimental | Receive computer games training for 30 minutes and 30 minutes traditional OT.There are 3 sections for 1 week; the intervention period will be 8 weeks. Receives: Device: Kinect; Other: Traditional OT(30 Mins) |
| Traditional | Placebo comparator | The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks. Receives: Other: Traditional OT(60 Mins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Melbourme Assessment Scales
Measured: Children will be assesed at 8 weeks and 16 weeks
Secondary outcomes (6)
Change from Baseline in Quality of Upper Extremity Skills Test
Measured: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Motor-free perceptual assessment
Measured: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in ABILHAND-kids
Measured: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Box and Block Test
Measured: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Cerebral Palsy Quality of Life for Children (CP QOL-Child) questionnaire
Measured: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Visual analogue scale
Measured: Children will be assesed at 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen-Wen Hung, MD, Principal investigator, Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364245
- Sponsor's protocol ID
- CMRPG8D0941
- Status last verified
- Nov 2014
- First submitted
- 26 Jan 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
PubMed 21950396Gordon AM, Charles J, Wolf SL. Methods of constraint-induced movement therapy for children with hemiplegic cerebral palsy: development of a child-friendly intervention for improving upper-extremity function. Arch Phys Med Rehabil. 2005 Apr;86(4):837-44. doi: 10.1016/j.apmr.2004.10.008.
PubMed 15827942Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.
PubMed 16510616Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.
PubMed 23433275Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics. 2004 Feb;113(2):305-12. doi: 10.1542/peds.113.2.305.
PubMed 14754942Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Participation outcomes in a randomized trial of 2 models of upper-limb rehabilitation for children with congenital hemiplegia. Arch Phys Med Rehabil. 2011 Apr;92(4):531-9. doi: 10.1016/j.apmr.2010.11.022.
PubMed 21440700Galvin J, McDonald R, Catroppa C, Anderson V. Does intervention using virtual reality improve upper limb function in children with neurological impairment: a systematic review of the evidence. Brain Inj. 2011;25(5):435-42. doi: 10.3109/02699052.2011.558047. Epub 2011 Mar 14.
PubMed 21401370Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
PubMed 21901720Fehlings D, Switzer L, Findlay B, Knights S. Interactive computer play as "motor therapy" for individuals with cerebral palsy. Semin Pediatr Neurol. 2013 Jun;20(2):127-38. doi: 10.1016/j.spen.2013.06.003.
PubMed 23948687Bilde PE, Kliim-Due M, Rasmussen B, Petersen LZ, Petersen TH, Nielsen JB. Individualized, home-based interactive training of cerebral palsy children delivered through the Internet. BMC Neurol. 2011 Mar 9;11:32. doi: 10.1186/1471-2377-11-32.
PubMed 21392370Fluet GG, Qiu Q, Kelly D, Parikh HD, Ramirez D, Saleh S, Adamovich SV. Interfacing a haptic robotic system with complex virtual environments to treat impaired upper extremity motor function in children with cerebral palsy. Dev Neurorehabil. 2010;13(5):335-45. doi: 10.3109/17518423.2010.501362.
PubMed 20828330Howcroft J, Klejman S, Fehlings D, Wright V, Zabjek K, Andrysek J, Biddiss E. Active video game play in children with cerebral palsy: potential for physical activity promotion and rehabilitation therapies. Arch Phys Med Rehabil. 2012 Aug;93(8):1448-56. doi: 10.1016/j.apmr.2012.02.033. Epub 2012 May 7.
PubMed 22571917Jannink MJ, van der Wilden GJ, Navis DW, Visser G, Gussinklo J, Ijzerman M. A low-cost video game applied for training of upper extremity function in children with cerebral palsy: a pilot study. Cyberpsychol Behav. 2008 Feb;11(1):27-32. doi: 10.1089/cpb.2007.0014.
PubMed 18275309Ritterband-Rosenbaum A, Christensen MS, Nielsen JB. Twenty weeks of computer-training improves sense of agency in children with spastic cerebral palsy. Res Dev Disabil. 2012 Jul-Aug;33(4):1227-34. doi: 10.1016/j.ridd.2012.02.019. Epub 2012 Mar 22.
PubMed 22502849Rostami HR, Arastoo AA, Nejad SJ, Mahany MK, Malamiri RA, Goharpey S. Effects of modified constraint-induced movement therapy in virtual environment on upper-limb function in children with spastic hemiparetic cerebral palsy: a randomised controlled trial. NeuroRehabilitation. 2012;31(4):357-65. doi: 10.3233/NRE-2012-00804.
PubMed 23232158
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02364245
- Acronym / sponsor ID
- CMRPG8D0941
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy., Upper Extremity, Kinect, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Feb 2015 (estimated)
- 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 design and evaluation the feasibility, effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral Palsy.
Detailed description
Background Children with cerebral palsy (CP) usually have various limitations in function of their upper limbs. Upper limbs function training is one of the important issues in CP rehabilitation. There is a growing interest in rehabilitation specialists to integrate commercialized interactive computer play into rehabilitation programs. According to the literature research, commercialized interactive computer play could improve speed and quality of movement, for hand or upper limb function, the results were mixed. The investigators think the interactive computer play could be feasible in upper limb training among children with CP. However, the investigators should integrate the rehabilitation training concept to the computer playing in order to get better outcome from such training. The electronic experts and rehabilitation experts should work together to reach the goal. Therefore, the aims of this study are 1.to design Kinect computer games as the rehabilitation training tool for upper limbs of children with CP, 2. to assess the feasibility and effects of the Kinect computer games.
Methods The investigators will spend around nine months to design the computer games. The investigators will search from the internet to download the computer games which are with no copy-right issue. The investigators will use Kinect sensor to catch the child's motion. The rehabilitation team will choose several upper limb motions which are common used in training for children with CP. Then Professor Chang's team will modify the software design to make those target motions to be the game control actions.When a prototype game is created, the investigators will invite two to four children with CP to pilot test the game. The game design will be completed till children and therapists satisfy the design.
Within one year and three months the investigators will do a randomized control trial to compare the effects between the Kinect games and traditional occupational therapy (OT) in the upper limb function of children in CP. The investigators will recruit 30 children and randomize them into two groups.
In each intervention section the intervention group will receive computer games training for 30 minutes and 30 minutes traditional OT. The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks.
Statistic methods Inter-group differences in baseline characteristics were evaluated using an independent t tests or Wilcoxon rank sum tests or χ2 analysis. Analysis of variance with repeated measures was used to determine the effects of intervention on each dependent variable. Model effects were group, time, and their interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinect | Experimental | Device: Kinect, Other: Traditional OT(30 Mins)Receive computer games training for 30 minutes and 30 minutes traditional OT.There are 3 sections for 1 week; the intervention period will be 8 weeks. |
| Traditional | Placebo comparator | Other: Traditional OT(60 Mins)The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cerebral Palsy
- 4-12 years old
- Cognition ability is good for evaluation and training
- Affected side: Manual ability classification system(MACS) I-III
Key exclusion criteria (3 listed)
- Accept Upper Extremity surgery before recruiting
- Accept Botox injunction three months before recruiting
- Unstable Seizure
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 |
|---|---|---|
| KinectReceive computer games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks. | Device | Kinect |
| Traditional OT(30 Mins)Receive Traditional Occupational Therapy training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks. | Other | Kinect |
| Traditional OT(60 Mins)Receive Traditional Occupational Therapy training for 60 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks. | Other | Traditional |
Primary outcome
Change from Baseline in Melbourme Assessment Scales
Time frame: Children will be assesed at 8 weeks and 16 weeks
6 secondary outcomes
Change from Baseline in Quality of Upper Extremity Skills Test
Time frame: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Motor-free perceptual assessment
Time frame: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in ABILHAND-kids
Time frame: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Box and Block Test
Time frame: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Cerebral Palsy Quality of Life for Children (CP QOL-Child) questionnaire
Time frame: Children will be assesed at 8 weeks and 16 weeks
Change from Baseline in Visual analogue scale
Time frame: Children will be assesed at 8 weeks and 16 weeks
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 2 Aug 2016.
- Background: PubMed 21950396Gordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
- Background: PubMed 15827942Gordon AM, Charles J, Wolf SL. Methods of constraint-induced movement therapy for children with hemiplegic cerebral palsy: development of a child-friendly intervention for improving upper-extremity function. Arch Phys Med Rehabil. 2005 Apr;86(4):837-44. doi: 10.1016/j.apmr.2004.10.008.
- Background: PubMed 16510616Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.
- Background: PubMed 23433275Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.
- Background: PubMed 14754942Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics. 2004 Feb;113(2):305-12. doi: 10.1542/peds.113.2.305.
- Background: PubMed 21440700Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Participation outcomes in a randomized trial of 2 models of upper-limb rehabilitation for children with congenital hemiplegia. Arch Phys Med Rehabil. 2011 Apr;92(4):531-9. doi: 10.1016/j.apmr.2010.11.022.
- Background: PubMed 21401370Galvin J, McDonald R, Catroppa C, Anderson V. Does intervention using virtual reality improve upper limb function in children with neurological impairment: a systematic review of the evidence. Brain Inj. 2011;25(5):435-42. doi: 10.3109/02699052.2011.558047. Epub 2011 Mar 14.
- Background: PubMed 21901720Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
- Background: PubMed 23948687Fehlings D, Switzer L, Findlay B, Knights S. Interactive computer play as "motor therapy" for individuals with cerebral palsy. Semin Pediatr Neurol. 2013 Jun;20(2):127-38. doi: 10.1016/j.spen.2013.06.003.
- Background: PubMed 21392370Bilde PE, Kliim-Due M, Rasmussen B, Petersen LZ, Petersen TH, Nielsen JB. Individualized, home-based interactive training of cerebral palsy children delivered through the Internet. BMC Neurol. 2011 Mar 9;11:32. doi: 10.1186/1471-2377-11-32.
- Background: PubMed 20828330Fluet GG, Qiu Q, Kelly D, Parikh HD, Ramirez D, Saleh S, Adamovich SV. Interfacing a haptic robotic system with complex virtual environments to treat impaired upper extremity motor function in children with cerebral palsy. Dev Neurorehabil. 2010;13(5):335-45. doi: 10.3109/17518423.2010.501362.
- Background: PubMed 22571917Howcroft J, Klejman S, Fehlings D, Wright V, Zabjek K, Andrysek J, Biddiss E. Active video game play in children with cerebral palsy: potential for physical activity promotion and rehabilitation therapies. Arch Phys Med Rehabil. 2012 Aug;93(8):1448-56. doi: 10.1016/j.apmr.2012.02.033. Epub 2012 May 7.
- 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.
Jen-Wen Hung, MD principal investigator
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinect, Traditional OT(30 Mins) and Traditional OT(60 Mins) in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 Aug 2016. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline in Melbourme Assessment Scales (time frame: Children will be assesed at 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364245, which also lists 37 linked publications.
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 2 Aug 2016.