None listed
Conditions
Brief summary
Cerebral palsy (CP) is a heterogeneous group of permanent disorders of the developing brain and the leading cause of childhood motor disability worldwide, with higher prevalence reported in low-and middle-income countries (LMICs). Children with severe motor impairment, particularly those who are non-ambulant, often experience poor postural control in sitting and require adaptive seating systems to promote upright posture, facilitate hand function and participation, and prevent secondary musculoskeletal complications. Although evidence suggests that adaptive seating devices improve functional performance, participation, caregiver support and independence, the available evidence remains limited. Approximately 40% of non-ambulant children with CP require long-term adaptive seating. In LMICs such as Nepal, access to adaptive seating is limited because of high costs and the lack of locally manufactured devices. The provision of low-cost adaptive seating devices may improve functional outcomes for this underserved population. We hypothesised that, compared with usual care (standard seating device), an intervention with adaptive seating device would improve occupational performance, measured using the adapted Nepali version of the Canadian Occupational Performance Measure (COPM), by a clinically meaningful difference of more than two points. Despite evidence supporting the benefits of adaptive seating, no randomised controlled trial has evaluated the effectiveness of a low-cost adaptive seating device on upper limb function, quality of life and caregiver burden in children with CP. Therefore, this study was designed to evaluate the effectiveness of a locally manufactured, low-cost adaptive seating device that is feasible for use in Nepal.
Interventions
Description of treatment. Treatment will consist of the daily use of a custom-built adaptive seating device with opportunities to spontaneously handle objects and interact with others for 3 weeks. A local seating engineer trained by the Asian Seating Assistance Project (ASAP) staff will build the seat using local materials. The adaptive seating device consists of a chair that:
• can be tilt-in-space by 30°
• is customised to the physical body dimensions of the child
• includes a pelvic and che
Description of treatment. Treatment will consist of the daily use of a custom-built adaptive seating device with opportunities to spontaneously handle objects and interact with others for 3 weeks. A local seating engineer trained by the Asian Seating Assistance Project (ASAP) staff will build the seat using local materials. The adaptive seating device consists of a chair that: • can be tilt-in-space by 30° • is customised to the physical body dimensions of the child • includes a pelvic and chest strap • includes a foot and back rest • allows a table to be attached for use in play, eating, writing, drawing, etc. • will be waterproof, easy to transport and detachable, light weight (~5 kg), and is padded Children in the treatment group will be assessed by a physiotherapist and measured for the adaptive seating device. The device will be delivered to the child, and the child and their family will be instructed by the same therapist in how to use the device in their home setting. They will be encouraged to sit the child in the chair for 6 hours per day. Adherence to the seating regime and total time spent sitting in the adaptive device will be monitored by the therapist or a research assistant via weekly phone contact. The overall duration for the responding outcome measures will take around one and half hour. The treatment protocol follow the Michelle Jackman the Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. The intervention duration might vary depending on the child ability, age, goals, resources, and family involvement but the maximum duration will be two hours a day for five days in a week.
The treatment will consist of the daily use of a custom-built adaptive seating device, providing opportunities for children to spontaneously handle objects and interact with others over a 4-week period. A locally trained carpenter will manufacture the adaptive seating device using locally available materials.
The adaptive seating device consists of a chair that:
• can tilt-in-space by up to 30°;
• is customised to the child's physical body dimensions;
• includes pelvic and chest straps;
• includ
The treatment will consist of the daily use of a custom-built adaptive seating device, providing opportunities for children to spontaneously handle objects and interact with others over a 4-week period. A locally trained carpenter will manufacture the adaptive seating device using locally available materials. The adaptive seating device consists of a chair that: • can tilt-in-space by up to 30°; • is customised to the child's physical body dimensions; • includes pelvic and chest straps; • includes adjustable foot rest and chair seat with back rests; • allows a table to be attached for play, eating, writing, drawing, and other activities; and • is waterproof, lightweight (approximately 5 kg), padded, detachable, and easy to transport. Children in the treatment group will be assessed by a physiotherapist and measured for the adaptive seating device. The device will then be delivered to the child, and the child and their family will be instructed by the same physiotherapist on its use within the home environment. Families will be encouraged to use the adaptive seating device for approximately 4–6 hours per day, where practical, to support the child's participation in everyday activities. Adherence to the seating programme and the total time spent using the adaptive seating device will be monitored by the physiotherapist or a research assistant through weekly telephone follow-up. Assessment of the outcome measures will take approximately 1.5 hours to complete. The treatment protocol follows the recommendations of Michelle Jackman et al. in the International Clinical Practice Guideline: Interventions to Improve Physical Function for Children and Young People with Cerebral Palsy. The duration of structured physiotherapy activities performed while the child is using the adaptive seating device may vary depending on the child's abilities, age, goals, available resources, and family involvement. However, the maximum duration of structured intervention will be up to 2 hours per day, 5 days per week. This structured intervention is separate from the recommended daily use of the adaptive seating device (4–6 hours per day), which includes routine activities such as play, feeding, learning, and other daily tasks.
Sponsors
Cerebral Palsy Research Alliance
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
• 60 children with cerebral palsy (CP) of any motor type and topography • Gross Motor Functional Classification System (GMFCS) III-V • aged 5-16 years • adaptive seating intervention naïve, including not been supplied with or used a corner seat. (This may mean that they have been left on the floor for most of the day or they may have been placed in various forms of seating for feeding etc by parents. This will be confirmed by history taking at the initial assessment and recorded in our data collection sheets.)
Exclusion criteria
• Uncontrolled epilepsy or drug resistant epilepsy (International League Against Epilepsy criteria) • Vision impairment • Ventilator dependent
Outcome results
None listed