Cerebral PalsyNCT03622970
Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy
A study testing VGBT with Nintendo® Wii and LMC games and NDT-based upper limb rehabilitation in people with Cerebral Palsy and Rehabilitation, run by Istanbul University.
Trial summary
The aim of the present study is to compare the effects of Neurodevelopmental Treatment (NDT)-based upper limb rehabilitation and video-game based therapy (VGBT) with Nintendo® Wii and LMC games on upper extremity functions in patients with Cerebral Palsy (CP). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Rehabilitation
- What is being tested?
- VGBT with Nintendo® Wii and LMC games and NDT-based upper limb rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2015to 23 Aug 2018
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The health committee report has received a CP diagnosis
- Being between 5-18 years of age
- According to Modifiye Ashworth Scale (MAS), upper extremity spasticity (0), (1), (1+)
- Ability to adapt to exercises (According to the health report mental level normal or "mild mental retardation"
Who cannot join
- Botulinium Toxin (BOTOX) injection for the upper extremity in the last 6 months
- Does not have epileptic epilepsy
- Any person who has been diagnosed as having any absence of a cardiac or orthopedic condition
- Admission of family treatment
About this study
The aim of the present study is to compare the effects of Neurodevelopmental Treatment (NDT)-based upper limb rehabilitation and video-game based therapy (VGBT) with Nintendo® Wii and LMC games on upper extremity functions in patients with Cerebral Palsy (CP).
Read the detailed description
The investigators hypothesized that VGBT using the Nintendo® Wii and LMC would be a usable tool to train manual dexterity in patients with CP as comprehensive and holistic therapy.
The NDT program for both groups will be routinely applied according to each child's individual needs and included tonus regulation, support of sensation, perception and motor development for gross motor function.
The two different patient-centered rehabilitation programs will be conducted with an average of one hour sessions three times a week for 8 weeks in both groups. The two different patient-centered programs will be as VGBT with Nintendo® Wii and LMC games (Group I) and NDT-based upper limb rehabilitation (Group II).
- Conditions
- Cerebral Palsy, Rehabilitation
- Being tested
- VGBT with Nintendo® Wii and LMC games, NDT-based upper limb rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGBT with Nintendo® Wii and LMC gamesDevice
Nintendo Wii and LMC games will be used for upper limb rehabilitation in Cerebral Palsy. The games are tennis and boxing for Nintendo Wii, Leapball and CatchApet for LMC.
NDT-based upper limb rehabilitationBehavioural
NDT-based upper limb rehabilitation includes using real materials (clothes, spoons, pencils, buttons, rope, etc.) such as getting dressed and eating etc. Also, It will practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.
| Study group | Role | What they receive |
|---|---|---|
| VGBT with Nintendo® Wii and LMC games | Experimental | VGBT with Nintendo® Wii and LMC games:
In order to improve the elbow and shoulder functions, Tennis and boxing, the games of Nintendo Wii® Fit WiiSports package that includes shoulder and elbow movements will be used for VGBT with Nintendo® Wii and Leap Motion Controller (LMC) games. In both of the games, the activities are carried out by providing feedback in the context of remote control and sound and vibration notifications. Receives: Device: VGBT with Nintendo® Wii and LMC games |
| NDT-based upper limb rehabilitation | Active comparator | NDT-based upper limb rehabilitation:
NDT-based upper limb rehabilitation aims to facilitate normal movement for upper extremity activities such as getting dressed and eating etc by using real materials (clothes, spoons, pencils, buttons, rope, etc.). The target activities were practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools. Receives: Behavioral: NDT-based upper limb rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Hand Dexterity Test
Minnesota Manual Dexterity Test (MMDT): is a short version of the Minnesota Dexterity Tests and consists of two timed sub-tests ("placing" and "turning tests") to assess the required manual dexterity to turn and/or place 60 short, round blocks with one or both hands . In this study, the placing sub-test will be used to assess the ability to handle objects, measured by the time required to complete the task.
Measured: Change from baseline to 8 weeks, follow up at two months
Secondary outcomes (2)
Modified Ashworth Scale
Modified Ashworth Scale (MAS) measures the muscle spasticity rate (score, 0-5). Spasticity of wrist flexors, elbow flexors and forearm pronators will be assessed due to MAS in this study. Participants sat with their forearm fully supported and will be instructed to relax. The measurer moves the wrist into extension as fast as possible and then rated the quality of the muscle reaction to stretch on a scale from 0 to 5, with 0 representing no spasticity.
Measured: Change from baseline to 8 weeks, follow up at two months
Hand and pinch grips
Grip strength was measured using a standard adjustable handle Jamar® Plus+Hand Dynamometer (Irvington NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90. Pinch strengths (tip, key and palmar pinch) will be measured by a hydraulic pinch gauge (Irvington NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90. Pinch positions will be defined using the American Society for Hand Therapists guideline. Each of grip and pinch strength tests will be performed thrice with a 30-sec interval between tests, and the mean value will be recorded.
Measured: Change from baseline to 8 weeks, follow up at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start3 Mar 2015
- Primary completion13 Aug 2018
- Study completion23 Aug 2018
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 Istanbul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saime Nilay Arman, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622970
- Sponsor's protocol ID
- 108400987
- Status last verified
- Nov 2018
- First submitted
- 22 Jul 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03622970
- Acronym / sponsor ID
- 108400987
- Conditions
- Cerebral Palsy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 9 Aug 2018 (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 present study is to compare the effects of Neurodevelopmental Treatment (NDT)-based upper limb rehabilitation and video-game based therapy (VGBT) with Nintendo® Wii and LMC games on upper extremity functions in patients with Cerebral Palsy (CP).
Detailed description
The investigators hypothesized that VGBT using the Nintendo® Wii and LMC would be a usable tool to train manual dexterity in patients with CP as comprehensive and holistic therapy.
The NDT program for both groups will be routinely applied according to each child's individual needs and included tonus regulation, support of sensation, perception and motor development for gross motor function.
The two different patient-centered rehabilitation programs will be conducted with an average of one hour sessions three times a week for 8 weeks in both groups. The two different patient-centered programs will be as VGBT with Nintendo® Wii and LMC games (Group I) and NDT-based upper limb rehabilitation (Group II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VGBT with Nintendo® Wii and LMC games | Experimental | Device: VGBT with Nintendo® Wii and LMC gamesVGBT with Nintendo® Wii and LMC games: In order to improve the elbow and shoulder functions, Tennis and boxing, the games of Nintendo Wii® Fit WiiSports package that includes shoulder and elbow movements will be used for VGBT with Nintendo® Wii and Leap Motion Controller (LMC) games. In both of the games, the activities are carried out by providing feedback in the context of remote control and sound and vibration notifications. |
| NDT-based upper limb rehabilitation | Active comparator | Behavioral: NDT-based upper limb rehabilitationNDT-based upper limb rehabilitation: NDT-based upper limb rehabilitation aims to facilitate normal movement for upper extremity activities such as getting dressed and eating etc by using real materials (clothes, spoons, pencils, buttons, rope, etc.). The target activities were practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The health committee report has received a CP diagnosis
- Being between 5-18 years of age
- According to Modifiye Ashworth Scale (MAS), upper extremity spasticity (0), (1), (1+)
- Ability to adapt to exercises (According to the health report mental level normal or "mild mental retardation"
Key exclusion criteria (4 listed)
- Botulinium Toxin (BOTOX) injection for the upper extremity in the last 6 months
- Does not have epileptic epilepsy
- Any person who has been diagnosed as having any absence of a cardiac or orthopedic condition
- Admission of family treatment
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 |
|---|---|---|
| VGBT with Nintendo® Wii and LMC gamesNintendo Wii and LMC games will be used for upper limb rehabilitation in Cerebral Palsy. The games are tennis and boxing for Nintendo Wii, Leapball and CatchApet for LMC. | Device | VGBT with Nintendo® Wii and LMC games |
| NDT-based upper limb rehabilitationNDT-based upper limb rehabilitation includes using real materials (clothes, spoons, pencils, buttons, rope, etc.) such as getting dressed and eating etc. Also, It will practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools. | Behavioural | NDT-based upper limb rehabilitation |
Primary outcome
Minnesota Hand Dexterity Test
Time frame: Change from baseline to 8 weeks, follow up at two months
Minnesota Manual Dexterity Test (MMDT): is a short version of the Minnesota Dexterity Tests and consists of two timed sub-tests ("placing" and "turning tests") to assess the required manual dexterity to turn and/or place 60 short, round blocks with one or both hands . In this study, the placing sub-test will be used to assess the ability to handle objects, measured by the time required to complete the task.
2 secondary outcomes
Modified Ashworth Scale
Time frame: Change from baseline to 8 weeks, follow up at two months
Hand and pinch grips
Time frame: Change from baseline to 8 weeks, follow up at two months
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 6 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VGBT with Nintendo® Wii and LMC games and NDT-based upper limb rehabilitation in people with Cerebral Palsy and Rehabilitation, run by Istanbul University.
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 4 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Minnesota Hand Dexterity Test (time frame: Change from baseline to 8 weeks, follow up at two months). 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 6 Nov 2018.