A non-probabilistic sample will be recruited from the community. Individuals will be
included according to the following criteria: age ≥ 40 years; diagnosis of idiopathic PD
confirmed by a neurologist; classification between stages II to IV of the modified Hoehn
& Yahr Scale (HY); use of anti-parkinsonian medication with stable pharmacological
therapy for at least 6 months; ability to walk independently in a 14-meter corridor with
a walking speed ≤ 1.1 m/s (defined to screen individuals with gait impairments); ability
to use a single-point cane during walking correctly and safely without regular use of any
type of assistive device since the diagnosis of PD. Individuals with cognitive
impairment, using deep brain stimulation, or who present any other condition that may
compromise the test performance will be excluded. Two individuals with PD were involved
as collaborators in this study to contribute to the relevance of the research through the
inclusion of patient perspectives.
After baseline assessments individuals will be randomly allocated into the experimental
and control groups. After allocation, all individuals will be instructed to maintain
their usual healthcare routines.
Individuals in the experimental group will receive cane usage training, provided in four
sessions lasting 40 minutes each, spaced over a period of 15 to 22 days. Additionally,
they will be instructed and encouraged to use the cane in their daily mobility
activities, both indoors and outdoors, starting from the first day of training. To
monitor adherence, individuals will receive a diary to record on which occasions and for
how long they used the cane during gait activities. To enhance adherence, participants
will receive telephone follow-ups between sessions aimed at monitoring and encouraging
device use. Individuals will be re-evaluated after the end of the training sessions.
After revaluation, the canes will be left with participants who will be instructed as
follows: "Feel free to use the cane at any time as needed." Another diary will be
provided for the participant to record the use of the device after the end of the
intervention.
To ensure a comparable amount of attention received, individuals in the control group
will receive an intervention involving global stretching of the upper and lower limbs and
health education. The intervention will be provided in four sessions lasting 40 minutes
each, spaced for 15 to 22 days. Additionally, individuals allocated to the control group
will be instructed not to start using any assistive device during the study period and
encouraged to perform stretching daily at home from the first day of training. To monitor
adherence, individuals will receive a diary to record stretching exercises performed
daily. To enhance adherence, participants will receive telephone follow-ups between
sessions aimed at monitoring and encouraging the performance of the stretching
exercises.The intervention will be offered by the same physiotherapist responsible for
training the experimental group. Individuals will be re-evaluated after the end of the
training sessions. After revaluation, the participants will be instructed as follows:
"Feel free to continue stretching exercises and use the health information discussed as
needed." Another diary will be provided for the participant to record the stretching
exercises performed after the end of the intervention.
The primary outcomes is gait speed. Secondary outcomes include gait confidence, cadence,
step length, functional mobility, freezing of gait , fear of falls, and satisfaction with
the use of a cane. Adverse events will be monitored throughout the intervention. They are
defined as any unexpected medical issue related to the intervention-such as pain, falls,
or exercise intolerance-that requires hospitalization or additional treatment.
The sample size was calculated based on a clinically meaningful difference of 0.22 m/s
and a standard deviation of 0.15 m/s in the 10MWT for individuals with PD. With a 5%
significance level and 80% power, 18 participants were required. Considering a 30%
dropout rate, the final sample size was set at 26 (13 per group). However, this study
will utilize an adaptive design and the sample size will be re-estimated using the effect
sizes from the current study and recruitment will be adjusted accordingly. Between-group
differences will be measured using a two-way repeated measures ANOVA, considering
baseline, post-intervention, and follow-up assessments, following both intention-to-treat
and per-protocol approaches (α=0.05).