Context :
Cerebral palsy (CP) is the leading cause of motor disability in children, with a
prevalence of 1.77 cases per 1000 births. It is defined as a set of permanent
developmental disorders of movement and posture, resulting from a non-progressive brain
lesion affecting a developing brain. 60% of individuals with CP have a bilateral form. In
this group, 98% of diplegics and 24% of quadriplegics will be "walkers", but more often
than not with poor walking efficiency. In fact, these children show not only a reduction
in walking speed, but also markedly reduced endurance. What's more, these children have
reduced levels of physical activity, resulting in less participation in physical
activities throughout their lives. Associated with these changes in motor activity, CP
leads to morphological and architectural changes in the muscles, including reduced muscle
volume, shorter muscle fascicles and increased intramuscular fat. These "bad" adaptations
contribute to a reduction in muscle strength and power, leading to a progressive decline
in functional capacity in adolescence and adulthood, associated with a sedentary
lifestyle. In individuals with CP, gait training and muscle strengthening programs,
carried out separately, have shown, respectively, a relative efficacy in improving
walking activity and lower limb muscle strength. Rare programs combining these two
interventions have been shown to be of interest in mildly affected children. In the
geriatric population (without CP), where strengthening with heavy loads may be
contraindicated and difficult to implement, Blood Flow Restriction (BFR) training has
attracted considerable interest due to its simplicity of use and effectiveness. Indeed,
the application of an inflatable cuff to the proximal part of a limb restricting blood
flow, combined with low-load muscle strengthening, has shown similar effects to high-load
strengthening on muscle function. BFR was also combined with functional training, and
this combination showed superiority over functional training alone in improving
functional activity. BFR does not appear to cause side-effects in typical adolescents,
and has never been studied in children with CP.
Objectives and evaluation criteria :
Primary objective: to study the effect of a 10-week gait training program combined with
simultaneous blood flow restriction (BFR), using a commercially available device, on the
walking speed of children aged 8 to 18 with bilateral spastic cerebral palsy. To this
end, a comparison of patients' walking speed will be carried out between the period D-70
to D0 (standard rehabilitation) and the period D0 to D+70 (walking training program +
BFR). Walking speed will be assessed by the 10-meter walk test. The evaluation criterion
is the change in walking speed between D-70-J0 and D0-J+70.
Secondary objectives and evaluation criteria
To assess the effect of this gait training program combined with BFR on the following
levels of the International Classification of Functioning and Disability:
Functions :
Isometric strength of plantar flexors, knee extended and flexed, by electronic hand
dynamometer (DEM)
Isometric strength of knee flexors and extensors by DEM
Isometric strength of hip abductors by DEM
Pain intensity by numerical rating scale (NRS-11) (somato sensory function)
Activities :
Walking endurance by 6-minute walk test
Spontaneous and maximum walking speeds using the 10-meter walk test
Global motor activity via Gross Motor Function Measure - 66 (GMFM-66)
Spatial gait parameters: stride length, step length, base of support, step angle,
and temporal gait parameters: speed and normalized speed, cadence, percentage of
right and left support phase, right and left cycle time and double support time
(Gaitrite)
Participation:
Achievement of functional goals in terms of performance and satisfaction using the
Canadian Occupational Performance Measure (COPM)
Achievement of daily activities and mobility using the Pediatric Evaluation of
Disability Inventory as a computer adaptive test (PEDI-CAT)
Evaluate the feasibility of this gait training program associated with BFR.
Feasibility will be assessed by analyzing the percentage of children completing 80%
of the training program.
To evaluate the tolerance of the EMBRIN program of this gait training program
associated with BFR. Tolerance to the training program will be studied by assessing
pain before, during and after gait training with the NRS-11 scale (23), as well as
by notifying the occurrence of intercurrent medical events or complications. The
evaluation criteria are :
Change in NRS-11 pain score during gait training sessions;
The occurrence of intercurrent medical events or complications.
Evaluate participant satisfaction using the CSQ-8 satisfaction questionnaire.
Research scheme and progress This is a single-center prospective experimental pilot study
designed to assess the feasibility, tolerability and effect of a 10-week gait training
program combined with simultaneous blood flow restriction (BFR) on the walking speed of
children, aged 8 to 18, with bilateral spastic cerebral palsy. The children will receive
a 10-week intervention (1 week of habituation without BFR + 9 weeks with BFR) comprising
3 30-minute treadmill sessions per week. At each session, the first 5 minutes will enable
a gradual increase in speed, and then the maximum tolerated walking speed will be sought.
Maximum speed corresponds to the walking speed maintained by the child for an effort of
between 5 and 7 on Borg's 10-point VAS. The rehabilitator will encourage the child to
maintain this speed and provide feedback on performance. The BFR setting will maintain an
occlusion, at the root level of both lower limbs, of 60% of the total occlusal pressure.
During each session, pain will be assessed using the NRS-11 before the restriction is
placed, after 15 minutes of walking and within 5 minutes of the restriction being
removed. In the event of participant request or premature termination of the session, a
pain assessment will be added. A pain assessment will also be carried out 24 hours after
the training session.
Functional assessments carried out at baseline at T0 (D0-70d) and T1 (D0) will explore
the usual evolution of walking speed in children receiving usual care. Assessments at T2
(D0+35d) will explore the evolution of variables of interest halfway through the
intervention period. Evaluations at T3 (D0+70d) will assess the immediate effects of
therapy. Functional assessments will be carried out again at T4 (D0+100d) and T5 (D0+160)
to evaluate the medium-term effect of therapy.
Research duration Inclusion period: 24 months Duration of participation: 8 months maximum
Study duration: 32 months