None listed
Conditions
Brief summary
Study Aim The proposed research aims to measure whether functional splinting in addition to motor training leads to improved upper limb function in children with cerebral palsy and brain injury Background A functional splint is a device that is used to support a weak or ineffective joint or muscle, in order to improve a person's ability to use the limb which the splint is supporting. Splinting to facilitate hand function is a widely practiced intervention in the treatment of children with neurological conditions, although there is little evidence to support the effectiveness of this intervention. There is emerging evidence to support interventions that focus on active use of a limb to improve function. These repetitive, task-specific interventions aim to bring about changes at the neural level. The use of a functional splint may lead to an immediate improvement in function, however, as this in effect inhibits active use at the joint it is supporting, both the short-term and the long-term effect on function when using these splints is unknown. This study seeks to address the gap in literature regarding functional splinting efficacy, and make an important contribution to the evidence base in this field.
Interventions
This study is a 3 group randomised controlled trial, comparing hand splinting combined with motor training, with hand splinting alone or motor training alone. Duration of the intervention will be 2 weeks, with outcome measures being taken immediately after intervention, and 10 weeks after baseline assessment. Group 1- Functional splint only A functional hand splint is an external device applied with the purpose of supporting the hand in an ideal position to complete an activity. In this group, p
This study is a 3 group randomised controlled trial, comparing hand splinting combined with motor training, with hand splinting alone or motor training alone. Duration of the intervention will be 2 weeks, with outcome measures being taken immediately after intervention, and 10 weeks after baseline assessment. Group 1- Functional splint only A functional hand splint is an external device applied with the purpose of supporting the hand in an ideal position to complete an activity. In this group, participants will be provided with a hand splint that they will wear during activities over a 2 week period. It will be recommended that the splint be worn for 1 hour daily. Group 2 - Motor Training Only 'Motor training' is a rehabilitation intervention that involves task-specific, repititous activity that aims to induce changes in the neural pathways. For the purposes of this study, children will recieve a total of 10 intervention sessions, over a period of 2 weeks (10 x 1 hour training sessions, 5 times per week for 2 weeks). Children and their parents will be expected to practice those skills learnt in therapy sessions within the home environment for 1 hour daily. Group 3 Motor training combined with functional splinting - this intervention group will recieve a combination of functional splinting and motor training intervention. Participants will undergo 10 motor training sessions (10 x 1 hour training sessions, 5 times per week for 2 weeks), during which they will wear their functional hand splint. Children and their parents will be expected to practice those skills learnt in therapy sessions within the home environment for 1 hour daily (wearing their hand splint during this practice).
Sponsors
University of Notre Dame
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of a Cerebral Palsy or a Brain Injury 2. Impaired upper limb function as a result of the neurological condition 3. Restricted wrist range of motion/position of wrist impacting on ability to use hand effectively 4. Therapy goals related to hand function
Exclusion criteria
1. Manual Ability Classification Scale (MACS) level V (The MACS classifies a child's ability to use their hands for functional activities on a daily basis. MACS is a spectrum of I - V, with I being lest severe, and level V being most severe. Children who are classified as MACS level V require total assistance, and do not have the ability to actively use their hands for functionals tasks. Hence, in standard practice, these children would not be seen as candidates for the interventions being utilised in this study) 2. Known allergy to thermoplastic splinting material
Outcome results
None listed