Canada and India face a growing population of children with cerebral palsy (CP), with the condition occurring in 2 to 4 of every 1000 live births in North America and India, respectively [1-3]. Children with CP have deficits in fine and gross motor skills, often with co-occurring deficits in visual-spatial processing skills [4-6]. The ability to perform functional tasks with the upper extremities (UEs) is an important predictor of success in daily activities and participation in school, leisure, and social activities [7]. Therapy programs designed to improve UE motor and visual-spatial processing skills must strive to maximize neurodevelopmental capacities and prevent secondary disabilities [8,9].

There are different approaches to therapy for children with CP [10-17]. The effectiveness of these programs is proportional to the intensity and amount of training and the task-specificity of the exercise regime [18-21]. For example, constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive therapy (HABIT) are promising rehabilitation programs for restoration of hand-arm function. These treatment approaches stress that both functional demands and repetitive intensive training are important in the rehabilitation of fine motor skills and to restore functional skills. Typically CIMT needs administration of 6 hours a day and the child can use only the affected arm, making bimanual activities impossible to perform. There is growing evidence to support the idea of activity-dependent central nervous system (CNS) plasticity [22]. In addition, the notion is emerging that neural reorganization reflects learning achieved through generating real experiences, applying focused attention, simulating close-to-normal movements, and repetition [23]. However, it is difficult to engage children with CP in therapy for long periods of time and sustain motivation for the intense repetitive task practices. Thus, there is a need for innovative and cost-effective therapeutic approaches and tools that motivate children with CP to complete long-term neurorehabilitation programs and that provide opportunities to improve neurodevelopmental outcomes.

Parents and clinicians rate motivation as the most influential personal characteristic for adherence to therapy and for determining motor and functional outcomes in children with CP [24]. An emerging, promising approach to engaging children in therapy is to incorporate computer games in which a range of learning elements with interactive cognitive challenges help children to positively engage in activities. Studies have provided evidence of the benefits of video games in rehabilitation training and show that well-designed interactive games can improve players' motor skills and visual-spatial processing skills [24-30].

For this purpose, we developed the low-cost, computer-aided, game-based rehabilitation and learning platform CGR [31-37]. CGR combines fine or gross motor exercises and visual-spatial cognitive activities appropriate for children with CP in a game-based format. A motion detecting “Therapy Mouse” (Mobility Research, AZ) will be used as the computer game controller. It is a miniature and wireless plug-n-play computer interface device, which contains firmware and inertial sensors that allow physical motion, specifically instantaneous position, to be translated and interpreted as a standard motion of a Universal Serial Bus (USB) mouse, and which has high fidelity and responsiveness. Because the miniature motion mouse can be easily attached with Velcro to many objects, this approach provides a highly flexible therapy tool applied to fine or gross UE motor skills. Many objects with varied sizes, shapes, weights, surface properties, and functional demands can be used for exercise and for practicing a variety of gross or fine motor skills. Importantly, when the motion mouse is attached to the chosen object fun computer games can be played [8,28,31,36-37]. As CGR allows handling and manipulation of many objects (ie, ones commonly used in daily activities), activity goals can be imbedded in the therapy program. Many inexpensive modern games, “exergames,” and brain fitness games now exist that are visually rich, fun, and engaging, include a variety of visual-spatial tasks, and require choice and other planning type activities. Performing goal-directed manipulation tasks through engaging and guided repetition creates experiences crucial to improving the brain's ability to learn [10,37].

A randomized controlled trial (RCT) with an intention-to-treat is proposed to evaluate the effectiveness of the game-based rehabilitation program on fine manual dexterity, upper limb motor skills, and visual-spatial cognitive functions in children aged 4 to 10 years old diagnosed with CP. This single-blind randomized clinical trial with an active control arm will be conducted at 4 sites. Two groups of children will be examined: one group will receive the experimental game-based program and the other group will receive usual therapy (see Multimedia Appendix 1). The first hypothesis is that an engaging, game-based UE exercise regime will result in greater improvements in hand-arm function as compared to the usual outpatient physical therapy program. The second hypothesis is that the UE exercise program, which uses computer games having a variety of visual-spatial activities, will result in greater improvements in visuospatial cognitive functions as compared to the usual outpatient physical therapy program.

This study will evaluate the feasibility of the procedures such as recruitment, intervention delivery, participant retention, and measurement tools. Semi-structured interviews will be conducted with the parents of the children and with the treating therapists. The broad research questions are: “what were the experiences of the study participants with the game-based and current therapy programs, and on what context were the experiences based?” The qualitative findings of participant's and therapists' experiences will help to identify (1) perceived exercise benefits; (2) difficulties with the exercises and using the technologies; (3) engagement and motivational value of the computer games; (4) personal and environmental factors that influenced doing the exercises; and (5) recommendations and modifications for improving the exercise programs.

This randomized controlled, single-blind clinical trial with an active control arm will be conducted at the following 4 sites: (1) University of Manitoba and Rehabilitation Centre for Children at the Special Services for Children and Youth (SSCY) Centre (Drs Szturm, Rempel, Restall, and Mrs Kanitkar, Winnipeg, Manitoba, Canada); (2) SDM College of Physiotherapy, Dharwad in collaboration with Usha's School for Exceptional Children, Hubli (Drs Parmar, Savadatti, Kamate, and Naik, Karnataka, India); (3) Christian Medical College (Drs Sharma, Pandian, and Gandhi, Ludhiana, Punjab, India); and (4) Kasturba Medical College (Dr Narayan, Mangalore, Karnataka, India).

Children diagnosed with CP (N=140) between the ages of 4 and 10 years old with moderate UE impairments and fine motor control abnormalities will be recruited. The following screening tools will be used: (1) Manual Ability Classification System (MACS), level 2 to 3 [38]; (2) Gross Motor Function Classification Scale (GMFCS), levels 2 to 4 [39]; (3) Ashworth scale of spasticity in wrist and fingers, level 0 to 1+ [40]; and (4) the pediatric version of the Mini-Mental State Examination assessment scale, level 17 and above. This will be used to the screen level of cognitive function. For each site, we will use a permuted block randomization scheme stratified by age and level of impairment as measured by the MACS and GMFCS [41].

Exclusion criteria for the study will be (1) visual or auditory impairment such that they cannot see and interact with the video games; (2) secondary orthopedic complications due to neurodegenerative disease (NDD) or as a result of surgery to the upper limb that may have caused permanent changes in upper limb musculoskeletal structure; (3) recent Botulinum toxin therapy (less than 6 months); (4) seizures, or (5) complex communication disorders.

Ethical approval was obtained from the health research ethics boards of each site. For each site a permuted block randomization scheme will be used and stratified by age where 4- to 6-year-olds will be one subgroup and 6- to10-year-olds will be the other subgroup. Each program will take 16 weeks, with 3 45-minute sessions per week. A workshop and uniform training program will be organized at SDM College of Physiotherapy, Dharwad, India for physiotherapists who will provide the assessment and the 2 intervention programs. This will be attended by Dr Szturm and Mrs Anuprita Kanitkar who will organize and coordinate the therapy program. The 2 intervention groups will be treated in all 4 locations limiting biases like contamination. The therapists conducting the assessments will be blinded to group assignment.

The control group (n=70) will receive the usual, comprehensive physical therapy for 45 minutes per session 3 times a week for 16 weeks. The therapy protocols will be individualized for every participant according to their level of impairment and preset goals, based on the principles of intensive repetitive task practice programs such as CIMT and HABIT. These consist of stretching of spastic muscles (activity-based dynamic stretching with child's active involvement to the spastic upper limb muscle, particularly muscles which are required for preparatory techniques will be involved in lengthening) and UE weight bearing exercises (ie, UE weight bearing in fundamental or functional position in the form of scapular and upper thoracic rotation and/or push and pull with a vestibular ball while maintaining corrected scapular positioning). A variety of arm and hand activities will be practiced, such as reaching for rings, removing and putting them back, ball throwing, opening a bottle cap, turning a door knob, clay activities, picking marbles from sand, and putting pellets and pegs into sockets, etc.

A typical session for the experimental group (n=70) will consist of stretching exercises followed by the game-based exercise program. Similar to the concept of “shaping,” and consistent with CIMT principles, CGR takes advantage of ergonomic properties of common objects to amplify limited and small amounts of voluntary movement and then allows opportunities for an appropriate switch to objects having more demanding movement requirements or functional demands. CGR allows object properties (size, weight, texture, and surface properties) to be easily manipulated in therapy. This provides graded practice for activities that need to be repeated in daily activities and in play. An important element of the platform is the ability to incorporate movement precision. In this regard, we target finger-hand function and not just transport and/or reaching movements.

Different computer games require different levels of movement amplitude, speeds, precision levels, as well as repetition and appeal to individual preferences. Furthermore, many inexpensive “off the shelf” computer games have a broad range of visuospatial cognitive content. Knowledge of the therapeutic value (object and games activities) can allow the therapist to prescribe an integrated program to target specific goals, for example, speed, accuracy, endurance, visuospatial functions, and cognitive inhibition, and to exercise 2 or 3 fingers, the whole hand, and bimanual tasks tailored to individual child abilities.

In a manner similar to interval training, 6 to 8 objects selected for specific therapy goals will be used to play computer games. Objects can be selected for motor skill training of finger/wrist or elbow and shoulder motions, and also of bimanual controls. Each object manipulation exercise will be used for 2 to 4 minutes. A number of possible objects which, when instrumented with the motion mouse, can be used for the game-based exercise program is shown in Figure 1 (see also Szturm et al [31]). Many action and cognitive-type computer games are available to play; these will be selected by the treating therapist based on (1) degree of difficulty; (2) movement amplitude, speed, and accuracy; (3) visual-spatial processing requirement; and (4) personal preferences of the child. Common computer games that will be used in the game-based exercise program are shown in Textbox 1.

The Quality of Upper Extremity Skills Test (QUEST) is a commonly used outcome measure that evaluates quality of dissociated movements, UE gross motor function, and object manipulation in children with CP. It consists of 36 tasks evaluated in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. The tool has demonstrated excellent test-retest reliability [42], and through construct validity studies, has been demonstrated as a good measure of UE motor skill [43].

The following subtests of the Peabody Developmental Motor Scale, Second Edition (PDMS-2) will be used: (1) object manipulation (24-item subtest that measures a child's ability to manipulate balls); (2) grasping (a 26-item subtest that measures a child's ability to use his or her hands [44]); and (3) Visual-Motor Integration (VMI) subtest (a 72-item subtest that measures a child's ability to use visual perceptual skills). Both the PDMS-2 fine motor composite score and the VMI subtest score have shown high test-retest reliability and have good construct validity [45,46].

Immediately following the 16-week intervention, a semi-structured interview format will be used to ask parents about the 5 most important activities their child was trying or wanted to do, but was having difficulty performing and/or difficulty in retaining.