Feasibility and to explore the effect of biofeedback gait training on the GRAIL in clubfoot patients, over 4 years of age, with a mild relapse

Clubfoot in children can be treated successfully by the Ponseti method.
Unfortunately, approximately 11-48% of treated clubfeet develop a relapse
during follow up. Children with a relapsed clubfoot present around age 5 to 8
with a supination adduction gait pattern (Hosseinzadeh et al.,
2017b).Physiotherapy can potentially be useful in improving the gait pattern in
children with a mild relapse and pediatric orthopedic surgeons often refer
children with a mild clubfoot relapse to the pediatric physiotherapist.
Functional muscle coordination training might be able to reduce the imbalance
between in-and everting ankle-foot muscle and ligament forces and thus reduce
the dynamic supination in a part of the clubfoot population. This potentially
will decrease the number of operations (tibialis anterior tendon transfers)
necessary in this population. By our knowledge there are no studies published
that prove the efficacy of physiotherapy in a mild relapse.

In multiple clinical cases we noticed good results with physiotherapy training
(established by improvement in gait analysis before and after the training) but
it is unknown what type of physio-therapeutical intervention have good results.
We would like to know which interventions are effective to develop guidelines
for this patient group.

Biofeedback gait training is a proven method in exercise-based gait
rehabilitation in for example children with cerebral palsy(Booth et al.,
2018a). During this gait training children get real time feedback on
biomechanical parameters such as foot position or joint loading. It is risk
free and associated with lower costs as compared to surgery. While feasibility
and effectiveness of this training is proven in several other conditions in
adults and children, it is still unknown in clubfoot. (Booth et al., 2018a;
Keshner & Lamontagne, 2021a)

Is biofeedback gait training on the Gait Real Time Interactive Lab (GRAIL)
feasible in children with mild recurrent clubfoot over 4 years of age? And to
explore the effect in achieving clinically relevant immediate and short-term
improvements in ankle-foot positioning and ankle-foot joint loading patterns
during gait.

Cross sectional pilot study

6 weeks of GRAIL training through games at the Center for Rehabilitation of the
University Medical Center Groningen. We will use both longer existing games
used in usual care gait training and a game specific developed for clubfoot
patients with a mild relapse. The GRAIL uses an instrumented dual-belt
treadmill with pitch and sway, embedded force plates, a motion capture system,
electromyography (EMG) and virtual reality (VR) environment (no VR glasses, but
a big screen in front of the treadmill).
During the training on the GRAIL we are able to give real time visual feedback
on ankle-foot position while walking and guide the child to a more neutral
ankle-foot position. Training sessions target coordination, strength and
mobility deficits in the ankle and foot segments during walking.

- Training dose: 60 minutes, 2 times a week during a period of 6 weeks.
- Exercise difficulty will be gradually increased by manipulating:
• Size of target positions of the ankle and foot segments
• Walking speed
• Task complexity

- Biofeedback gait training will be performed by experienced pediatric physical
therapists and certified GRAIL operators.

In this study, we offer GRAIL training as an alternative to conventional
physiotherapy.
Children with recurrent clubfoot suffer from deficits in muscle strength and
joint coordination leading to a downward and internally rotated foot position
while walking. In this study we aim to facilitate a more normal foot
positioning while walking and thereby we might prevent surgery in mild
recurrent clubfeet with GRAIL training. Apposed to conventional physiotherapy,
GRAIL therapy provides real time feedback on biomechanical parameters such as
foot position or joint loading. This might result in more insight into which
exercises are useful in this patient group. GRAIL training is provided by
physiotherapists who are specifically trained to deliver GRAIL training. They
have extensive experience in training children with gait deviations. The GRAIL
is located at the Center for Rehabilitation Beatrixoord (Haren) of the
University Medical Center Groningen.
With the results of this pilot study on biofeedback training on the GRIAL, we
want to apply for future funding to establish long-term effectiveness and do
more research on whether low-end training tools such as wearables can be used
for biofeedback training instead of the GRAIL. In adults wearable biofeedback
tools are feasible with effectiveness matching closely an established
laboratory method (Karatsidis et al., 2018). In the future wearable biofeedback
tools could be used to support traditional physical therapy in children with a
clubfoot relapse at clinics and local hospitals or facilitate training in the
patient*s home environments to make biofeedback training more accessible.

Patients will benefit by receiving a training that might be more specific than
they would receive at conventional physiotherapy. Specific training might
improve the walking pattern as seen in relapse, which even will potentially
decrease the amount of surgery necessary in this population.

The burden for our patients will be the intensity of the training, 2 times a
week 6 weeks in a row at the Center for Rehabilitation Beatrixoord (Haren) of
the University Medical Center Groningen. A compensation of 25 euros per
participant will be given and travel expenses and parking costs will be
reimbursed. The place of residence is taken into account when approaching the
patients for this study. Compared with usual care an extra gait analysis is
performed 3 months after finishing the training program.