- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07705867
Effect of Dual Task Virtual Reality Training on Hand Function , Attention and Activity of Daily Life in Children With Hemiplegia (DT)
Effect of Dual-task Virtual Reality Training on Hand Function, Attention and Activity of Daily Life in Children With Hemiplegia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children with hemiplegia represent about 25% of all CP children. One of the most debilitating symptoms of hemiplegia, which may occur in more than 80 of children suffering from CP, is dysfunction of the upper limbs, especially the arms and hands.
Hand function is significantly compromised in children with hemiplegic CP. As a result, children with hemiplegic CP typically find it difficult to use the affected upper extremity.These children learn how to do tasks using their non-involved upper extremity (developmental disuse).Hemiplegic children have difficulty in using both hands together.This deficit limits their participation and require assistance in activities of daily living such as dressing, eating, and playing.The ability of hemiplegic children to reach, hold, and manipulate objects with their hands is one of their biggest challenges.Children with hemiplegia often show slower reaction times, reduced concentration, and difficulty maintaining focus during motor tasks. These attentional challenges limit the ability to coordinate movements, particularly during bimanual or dual-task activities.
Virtual Reality (VR) is an effective and engaging tool in the rehabilitation of children with CP. It offers interactive, multisensory environments that enhance motor learning and neuroplasticity through repetitive, task-specific practice. VR improves upper limb function, coordination, attention, and motivation while promoting bimanual training and daily functional skills more effectively than traditional therapy.Although VR based training has gained increasing interest in recent years, little studies have been conducted to evaluate it's dual task application .So the purpose of the current study is to evaluate the effect of dual task VR training on hand function , attention and activity of daily life in children with hemiplegic CP.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yosra soliman, master
- Phone Number: 01116085030
- Email: yosramagdy868@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Their age will be ranged from 7-12 years.
- Their degree of spasticity will be ranged from 1 to 1according to the Modified Ashworth Scale
- They will be on level 1 or II on Gross Motor Function Classification System (GMFCS)
- Their manual ability to handle objects in daily activities will be at level II according to Manual Ability Classification System (MACS)
- Children can understand and follow instructions.
Exclusion Criteria:
- The participants will be excluded if they have one of the following criteria:
- Severe sensory ,visual, auditory and cognitive impairments.
- Structural or fixed soft tissue deformities of the upper extremities.
- Botulinum toxin injections within the last six months.
- Unstable seizures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual Task Virtual Reality Training
twenty hemiplegic child will receive Dual Task Virtual Reality Training plus traditional physical therapy three time per week for 3 months
|
Children in this group will receive 45_60 minutes of dual task VR training. each session will consist of: Games will be in the form of a series of kinect adventure game,big league game, forza horizon, sports island freedom and Kinect sports game designed for Xbox 360 Kinect console which targeting bilateral hand use and attention. The games will be projected onto a 24-Inch screen monitor. Each session consisted of playing 1-2 trials in a row of each of 5 game.Time of each game will be 5-10 minutes. plus tradional therapy
Children in this group will receive designed occupational therapy training for 45-60 minutes.
each session will consist of:Ball activities: catching and throwing ball (large balls for 2 hand use) while following rules as pick only red balls,Transfer cubes from one hand to the other hand and counting out load while transferring, Clapping with both hands while increaseing speed, Opening and closing a jar while focusing on steps,Towering cubes while focusing to put large then small cubes, Turning cards and react only when target card appears,Transfer cubes from one colored container to another,Pick objects from a toy bag and to range them according to their colors, shapes (triangles, rectangle, circular), and size (small, medium, big) and naming each object with their color and shape.
|
|
Active Comparator: traditional physical therapy
twenty hemiplegic child will receive traditional physical therapy three time per week for 3 months
|
Children in this group will receive designed occupational therapy training for 45-60 minutes.
each session will consist of:Ball activities: catching and throwing ball (large balls for 2 hand use) while following rules as pick only red balls,Transfer cubes from one hand to the other hand and counting out load while transferring, Clapping with both hands while increaseing speed, Opening and closing a jar while focusing on steps,Towering cubes while focusing to put large then small cubes, Turning cards and react only when target card appears,Transfer cubes from one colored container to another,Pick objects from a toy bag and to range them according to their colors, shapes (triangles, rectangle, circular), and size (small, medium, big) and naming each object with their color and shape.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bilateral hand use
Time Frame: up to three months
|
The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) will be used to assess bilateral hand use.
It is a standardized norm-referenced measure for evaluating fine and gross motor skills in children and adolescents aged 4 to 21.
It includes 8 subtests with 4 motor areas: fine manual control, manual coordination, body coordination, and strength and agility.
The child's performance will be recorded and scored on each item, then later, each item will be converted from raw score to point score and from point score to scale score and at the end, from scale score to standard score
|
up to three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
attention
Time Frame: up to three months
|
RehaCom will be used to assess attention in this study.The testing procedures will be conducted in quiet environment free from any distraction which can affect children' performance.The child will seat comfortably on a chair with back support and feet flat on the floor, facing the computer screen at eye level.
The test will be explained in simple, child-friendly language, ensuring the child understands that they should focus and respond as accurately and quickly as possible.In the current study, attention and concentration module will be selected in the RehaCom software.
The test will begin at Level 1 and automatically will progress to higher levels of difficulty depending on the child's performance.The child will identify or react to target stimulus.Grey performance bar will appear on the left side of the screen to show how well the participant will perform in real-time
|
up to three months
|
|
life disability
Time Frame: up to three months
|
Functional independence measure for children (WeeFIM) consists of 3 domains with a total of 18 measurement items.
The subsets are categorized as self-care domain which includes 8 items (eating, grooming, bathing, lower and upper body dressing, toileting, as well as bowel and bladder control).
The mobility domain includes 5 items (chair, toilet, and tub transfers, walking or wheelchair management, and stairs).
The cognitive domain includes 5 items (language comprehension and expression, social interaction, problem solving, and memory).The minimum total score is 18 (total dependence in all skills) and the maximum required score is 126 (complete independence in all skills)
|
up to three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006211
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.