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The VRapeutic (Full-immersive game-based therapy) is new therapeutic Egyptian software. It has the potential to provide intensive, repetitive, and task-oriented training. It may increase children's motivation, enjoyment, active social participation. Children with UCP may experience varieties of associated health conditions as difficulty of movement, instability of postural balance, difficulty of motor planning and control which impact on UE function.
Ethical statement this study was approved by institutional Review Board of the faculty of physical therapy ,cairo university .Egypt (no.P.T.REC/012/004237) .
Study Design A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
Sample size estimation
will be conducted to determine the number of recruited children. G*POWER statistical software (version 3.1.9.2) will be used using α=0.05, power 80% allocation ratio N2/N1 =1.
Randomization The selected children will be assigned by simple randomization via closed envelopes into two equal groups (control and study); the envelope will be contained a letter indicating whether the child will be assigned to the control or to the study group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | • This group will receive conventional UE therapeutic program for 60 minutes each session including:
|
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| study group | Experimental | Children in this group will receive the same conventional UE therapeutic program as control group for 60 minutes in addition to virtual reality session using VRapeutic software gaming technology, Archeeko module (figure 3) for 30 min/3 sessions/week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional upper extremity therapeutic program | Other | • This group will receive conventional UE therapeutic program for 60 minutes each session including:
|
| Measure | Description | Time Frame |
|---|---|---|
| rang of motion | The IMU sensors will be used to detect changes in angular displacement of child arm, forearm (which allow 3D analysis of movements in three planes X.Y.Z), speed and direction. Placement of Sensors: Two sensors will be placed on the affected side, one around the arm distal to shoulder joint and the other around the forearm distal to elbow joint. The third sensor will be placed around the trunk. The child will be in standing position with head in neutral position, trunk erect. The examiner will ask the child to perform functional task in form of (reaching forward toward targets placed on wall in multilevel, hand over head). | period of treatment will be 2 succssive months |
| • ABILHAND-Kids questionnaire | will be administrated on an interview basis, the child will be asked to estimate their perception of the level of difficulty that faces during the performance of each activity in the list on a three-point ordinal scale of impossible, difficult, easy. Activities will be presented in random order to avoid any systematic effect. Activities not attempted in the last 3 months are not scored and are entered as missing responses (tick the question mark). | period of treatment will be 2 succssive months |
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Inclusion Criteria:
• Their ages will range from of 6 to 10 years.
Exclusion Criteria:
Children will be excluded from the study if they have any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Somaya E Sherif | Contact | 01062661942 | somaya.sherif@cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Eman I Elhadidy | Cairo University | Study Chair |
| Maya G Abd elwahab | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy | Giza | 12662 | Egypt |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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intervention Control Group: Children in this group will receive conventional UE therapeutic program for about 60 minutes/3session per week.
Children in this group will receive the same conventional UE therapeutic program as control group in addition to virtual reality session using fully-immersive VRapeutic software gaming technology (Archeeko module) for 30 min/3sessions/week for 8 weeks.
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A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
|
| full immersive VRapeutic software gaming technology | Other | • Children in this group will receive the same conventional UE therapeutic program as control group for 60 minutes in addition to virtual reality session using VRapeutic software gaming technology, Archeeko module (figure 3) for 30 min/3 sessions/week for 8 weeks |
|
| Faculty of Physical Therapy | Giza | 12662 | Egypt |