Static balance in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5qzs8h
• Date of registration: 04/01/2012
• Primary sponsor: Universidade Node de Julho - Brazil
• Public title: Static balance in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation
• Scientific title: Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial
• Date of first enrolment: 01/08/2011
• Target sample size: 34
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5qzs8h/
• Study design: Randomized controlled trial, two arms, single blind

Countries of recruitment

Brazil

Contacts

• Name: Claudia Oliveira
• Affiliation: Universidade Nove de Julho

• Name: Luanda Grecco
• Affiliation: Universidade Nove de Julho

Key inclusion & exclusion criteria

Inclusion criteria: Age between five and 12 years
Spastic, diplegic cerebral palsy
Motor function classified as Level I, II or III by the GMCFS
Independent ambulation with or without the need for a gait-assistance device (walker or crutches)
Dynamic equinus with indication for neuromuscular block with BT-A in the triceps surae
Availability for physical therapy twice a week for four months
The following inclusion criteria will also apply to one group of children: 1) degree of cooperation compatible with the administration of NMES and 2) tolerance to NMES at a motor threshold level (visible muscle contraction).

Exclusion criteria: Neurological or orthopedic conditions unrelated to cerebral palsy
Orthopedic surgery on the lower limbs in the 12 months prior to selection
Surgery scheduled during the period of the study
Equinus not reducible to neutral (ankle at 0 degrees) or incompatible with the use of orthoses following the application of BT-A in the triceps surae


Age minimum: 5Y
Age maximum: 12Y
Gender: -

Health Condition(s) or Problem(s) studied

Cerebral palsy Static balance Physical therapy
C10.228.140.140.254
G11.427.690
H02.010.625

Intervention(s)

All participants will be submitted to the administration of BT-A in the lower limbs, performed by a single specialist in physical rehabilitation. The injected muscles will be determined based on the assessment of the specialist during the screening of the participants. The muscles to be injected are the gastrocnemius (lateral and medial), hip adductors and/or hamstrings, unilaterally for hemiplegic children and bilaterally for diplegic children. Body mass and application site will be considered for the calculation of the maximal dosage per patient. The maximal dose of BT-A (BOTOX, Allergan, Brazil) will be between 6 and 12 U/Kg of body mass, with a maximal possible dose of 200 U in compliance with the Brazilian Ministry of Health. Each vial of BT-A will be reconstituted with 3 to 5 mL of saline solution (NaCl 0.9%). The localization of the belly of the muscle will be determined with the children in ventral decubitus. Asepsis of the skin will be performed with 10% alcohol and none of the participants will receive sedation.

The standardized program proposed by Ibrahin et al. (2007) will be used for the treatment of all children in both groups. One-hour sessions will be held three days a week on non-consecutive days. The protocol will last four months beginning with the administration of BT-A and will not undergo any alterations in this period. The program will consist of the following:
- muscle stretching for all muscles that can be stretched, especially those submitted to BT-A;
- Use of a ankle-foot positioning orthosis for the correction of the deformity in plantar flexion of the ankle and to maintain the length and elasticity of the ankle muscles;
- gait training exercises, stressing the action of the ankle dorsiflexors, with different obstacles placed in the walking path; training in going up and down stairs.

The tibialis anterior muscle will be selected (bilaterally), with surface electrodes (5 cm X 5 cm) positioned on the motor point o

Primary Outcome(s)

Investigate the effect of NMES on dorsiflexor muscles in combination with motor physical therapy on static balance (oscillations from the center of pressure in the anteroposterior and mediolateral directions) in children with CP submitted to BT-A in the lower limbs in order to diminish spasticity.

Static balance will be evaluated using a pressure platform (Medicapteurs Fusyo) This device measures oscillations in the center of pressure (COP) and contact time between the feet and the surface of the platform. The acquisition frequency will be 40 Hz. The children will be placed in an orthostatic position, barefoot, with arms alongside the body and eyes focused on a point marked at a distance of one meter positioned at the height of the glabella of each child. The evaluation will be carried out under two conditions for 30 seconds each: eyes open and eyes closed. The data will be recorded and interpreted using the Fusyo Analysis software program.

Secondary Outcome(s)

Investigate the effect of NMES in the ankle dorsiflexor muscles in combination with motor physical therapy on functional balance, as assessed by the Berg Balance Scale, in children with CP submitted to BT-A in the lower limbs.

The Berg Balance Scale will be used for the assessment of functional balance. This is a simple 14-item measure that addresses the performance of functional balance common to daily living. Each item has a five-option ordinal scale ranging from 0 to 4 points, with a maximal overall score of 56. The points are based on the time in which a position is maintained, the distance an upper limb is able to reach in front of the body and the time needed to complete the task. Execution time is approximately 30 minutes. The children will perform these tasks dressed, but barefoot.

Secondary ID(s)

200903/2008

Source(s) of Monetary Support

Universidade Node de Julho - Brazil

Secondary Sponsor(s)

Universidade Node de Julho - Brazil