None listed
Conditions
Brief summary
The abnormal movements and posture in children with cerebral palsy who have moderate to severe disability can lead to impaired sit-to-stand function which can in turn impact on children’s ability to independently perform mobility and self-care tasks. Therefore, the primary aim of this pilot trial is to investigate the effects of sit-to-stand task-specific training on mobility and self-care function in children with cerebral palsy with moderate to severe motor dysfunction. The secondary aims are: to evaluate the effects of sit-to-stand training on: sit-to-stand performance and caregiver burden; while exploring the experiences and perceived positive and negative effects of the training on primary caregivers; their adherence to the intervention; and identification of any adverse events associated with training. This study will be conducted in Thailand, with 42 children with cerebral palsy aged 4 to 12 years randomly allocated to routine physiotherapy or sit-to-stand exercise training in addition to routine physiotherapy. Outcomes will be measured at baseline and 7 weeks after randomisation. It is hypothesised that sit-to-stand task-specific training is a feasible and useful intervention for improving mobility and self-care functions in children with cerebral palsy who have moderate to severe disability.
Interventions
- Brief name of intervention: A sit-to-stand exercise program
- Procedures: Children will receive 1 hour of physical therapy which consists of 30 minutes of sit-to-stand training and 30 minutes of regular physiotherapy. Sit-to-stand training has three phases: 1) repetition of part of the sit-to-stand task, 2) repetition of all the sit-to-stand movement, and 3) repetition of all the sit-to-stand movement applied within the context of self-care tasks. The regular physiotherapy program consists of
- Brief name of intervention: A sit-to-stand exercise program - Procedures: Children will receive 1 hour of physical therapy which consists of 30 minutes of sit-to-stand training and 30 minutes of regular physiotherapy. Sit-to-stand training has three phases: 1) repetition of part of the sit-to-stand task, 2) repetition of all the sit-to-stand movement, and 3) repetition of all the sit-to-stand movement applied within the context of self-care tasks. The regular physiotherapy program consists of 15 minutes of balance training in sitting and standing and 15 minutes of walking training with assistive devices that the individual child usually uses. (The details of balance training and walking training will be individualised depending on the child’s ability.) - Who provided: Two registered physiotherapists experienced in working with children with cerebral palsy. Child’s caregiver for the home program. - Mode of delivery: Individually face-to-face 1 physiotherapist per 1 child and individually face-to-face 1 caregiver per 1 child. - When and how much: Training duration is 6 weeks, the frequency of the training is 5/week, and session length 60 minutes; 30 minutes in a sit-to-stand training program and 30 minutes in regular physiotherapy. - Intensity and volume: 3 sets of 25 repetitions of sit-to-stand and rest between each set 2-3 minutes for the second phase of the sit-to-stand training program. Thus, repetitions in this phase will be 75 repetitions/day. - Where: 2 days a week in the private training room, located in the Physical Therapy Unit of Songklanagarind hospital, Thailand. And 3 days a week at child’s home as the home program which is the same exercise, time, frequency and duration as in the Physical Therapy Unit of Songklanagarind hospital. - How well: Physiotherapists and parents will complete an exercise diary recording the number of repetitions of sit-to-stand in each session.
Sponsors
Faculty of Medicine, Prince of Songkla University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be children with cerebral palsy aged 4 to12 years. The inclusion criteria of this study are as follows: (1) any type of cerebral palsy (e.g. spastic, athetoid, ataxic); (2) classified as level III to IV on the Gross Motor Function Classification system (GMFCS); (3) able to sit-to-stand with or without assistance of caregiver or furniture without falling; (4) able to follow simple verbal instruction such as, ‘stand up, please’. Caregivers of these children will be included if they are the primary carer for the child, and they speak Thai fluently.
Exclusion criteria
Children will be excluded if they meet any of the following criteria: (1) had an orthopedic intervention, selective dorsal rhizotomy, or botulinum toxin injection to the lower extremities within the previous 6 months; (2) orthopedic problems or medical conditions such as Osteogenesis Imperfecta, Arthrogryposis Multiplex Congenita, or Spinal Muscular Atrophy, that prevent children from participating in the exercise training. Caregivers of these children will be excluded if they cannot understand and speak Thai fluently.
Outcome results
None listed