Cerebral palsy (CP) is the most common cause of childhood physical disability, affecting
2.0-2.5 in 1000 children. CP represents a group of disorders of movement and posture with
impairments (e.g., muscle weakness, decreased selective motor control, alterations in
muscle tone, and impairment of postural control) that collectively affect functional
mobility. About 65% of children/youth with CP use minimal or no assistive devices (leg
braces, walkers, and/or wheelchairs) to walk (i.e., Gross Motor Function Classification
System (GMFCS) Levels I and II) while children in GMFCS Levels III - V require varying
degrees of bracing, walkers and other walking devices, wheelchairs, or assistance from
others for mobility.
Robotic Assisted Gait training devices are increasingly used with children with CP to
improve their gait related motor skills. The Lokomat® (LOK) is a commercially available
robot assisted gait training system that uses robotics to simulate walking. It
facilitates inter-limb co-ordination and gait cycle timing and provides variable degrees
of body weight support and guidance.
This study represents the first adequately powered RCT to evaluate the effectiveness of
robot assisted gait training for children with CP. The qualitative aspect will give
contextual information to assist with interpretation of the RCT and provide valuable
information about families' experiences with the interventions.
The research questions for this study are:
i) What is the comparative effectiveness of robot assisted gait training (LOK) and fPT
program for improving gait related motor skills of ambulatory children and youth with CP?
ii) Does combining LOK and fPT result in greater improvements in gait related motor
skills of ambulatory children and youth with CP than robot assisted gait training or fPT
alone? iii) What are families' experiences with trial participation and what implications
do they have for interpretation of the quantitative results and the use of robot assisted
gait training and fPT in clinical settings?
Methods This trial is a concurrent, mixed methods study. Specifically, the quantitative
arm is a multi-centre RCT with four groups (22 factorial design, i.e., LOK
absent/present, fPT absent/present) with two periods of post-intervention assessments
(immediate and 3 months later). The RCT is linked with an interpretive descriptive
qualitative study arm. The three study sites are Holland Bloorview (Toronto, Ontario,
Canada), Glenrose Rehabilitation Hospital (Edmonton, Alberta, Canada) and Rehabilitation
Institute of Chicago (Chicago, IL).
Participants - Children aged 5-18 with CP, GMFCS levels II and III. Inclusion/Exclusion
criteria included in protocol in documents section.
Randomization - Following the baseline assessment, participants will be randomly
allocated to one of the four groups using computer-generated random sequence.
Blinding Physical therapist assessors and data analysts will be blinded to group
allocation.
TreatmentThere are three intervention groups: 1) LOK, 2) LOK + fPT, 3) fPT, and 4) one
maintenance therapy control (CONT) arm. All three intervention groups will receive two
50-minute sessions per week, conducted over 8 -10 weeks. Children in all four groups can
continue to participate in 'maintenance therapy'. Each child will be assigned to a
treatment team of two trained PTs who will share responsibility for the 8 to 10 week
intervention phase.
LOK - two 50-minute sessions on the Lokomat® per week. The study manualized LOK walking
protocol provides methods for progressing/tracking including a 5-minute over ground
walking session after the LOK to facilitate transfer of motor learning from the Lokomat
to usual walking devices.
fPT Participants will Two 50-minute sessions per week. The manualized motor-learning
based protocol forms the basis for this intervention. Its focus is on balance and
multi-plane gait-based motor skills.
LOK + fPT group protocol: Participants will alternate between LOK and one fPT session per
week for the duration of the 8 to 10 week intervention phase.
Monitoring co-interventionsMaintenance therapies such as home stretching and
strengthening routines can be continued for all 4 groups throughout the study because
these therapies have questionable efficacy, and will likely be equally used across all
four groups as they are common PT recommendations.
Outcomes - All study outcomes will be measured pre-/post-intervention (< 10 days
pre-intervention and post-completion), and at 3m follow-up (+/- 10 day window) by trained
physical therapists. Data will be entered into REDCap.
Primary Outcome - The primary outcome measure is the Gross Motor Function Measure-66
(GMFM-66 Dimensions D (Stand) and E (Walk/Run/Jump).
Secondary Outcomes - Secondary outcomes are measures of walking capacity(6 minute walk
test) fitness (adapted shuttle run test), balance (Pediatric Berg Balance Scale, Quality
Function Measure (FM), and Activities Balance Confidence Scale), functional abilities
(PEDI-CAT), physical activity levels (accelerometry), participation (Participation and
Environment Measure for Children and Youth), physical activity self-efficacy
(Self-Efficacy for Physical Activity), individualized goal attainment (Canadian
Occupational Performance Measure (COPM) and Goal Attainment Scaling), and quality of life
(KidScreen and Students' Life Satisfaction Scale).
Statistical Analysis - Data will be described (e.g., means, standard deviations,
frequencies) for each intervention group and each stratification variable. Mixed-effects
multiple linear regression models will be developed for each outcome with centre as a
random effect, centre by intervention as an interaction (to assess centre effect), and
other important variables (e.g., age and GMFCS level) as covariates. All main analyses
will be based on intent-to-treat with secondary analyses of those with >80% adherence to
their intervention.
Qualitative Component
The three objectives of the concurrent qualitative component are to explicate:
Child and parent experiences with the trial interventions and the values and
previous experiences that shape their perceptions.
The mobility related outcomes that are important to families and factors that
influence these views.
Child and family values, experiences and contextual factors that influenced
participation in the trial, including the follow-up period.
Design Interpretive description
Sample selection- The investigators will invite a subset of child-parent dyads from each
of the active interventions in the RCT. In addition, parents of children who were
eligible but declined to participate in the RCT will be invited to participate in the
qualitative component to address objective #3. The estimated sample size is (i.e., 6
child/parent dyads plus 3 parents from each site).
Data Collection - Parents will participate in 45-60 minute semi-structured, individual
interviews conducted by one member of the research team. Participating parents of
children in the RCT will be interviewed at 2 points within the trial: i) after completion
of the COPM and prior to receiving the intervention, and ii) within one month of
intervention completion.
Children from the RCT will participate in individual interviews at the end of their
LOK/fPT intervention. A customizable "tool box" of age-appropriate child-friendly
techniques including photographs and comic captioning, vignettes, and sentence starters
will be used in a 30-45 minute semi-structured interview with the child without the
parent present.
Data Management and Analysis Interviews will be digitally audio-recorded, transcribed
verbatim by a professional transcriptionist, de-identified and imported into NVivo for
data management. Two researchers will collaboratively identify general coding categories.
The researchers will meet to establish consensus on the coding.