Introduction: Although individuals with Parkinson's disease (PD) commonly use assistive devices, the effects of these devices on gait remain poorly understood. Furthermore, previous studies on this topic only investigated the immediate effects of device usage, and the investigated outcomes were predominately performance-based neglecting participant-centered outcomes.
Objective: To investigate the effect of cane training and use on gait speed (primary outcome), gait confidence, cadence, step length, functional mobility, freezing of gait, fear of falls and satisfaction with the use of a cane (secondary outcomes) in individuals with PD.
Methods: A double-blind, randomized controlled trial with intention-to-treat and per-protocol analysis will be carried out. A total of 26 individuals with PD will be recruited based on the following inclusion criteria: age ≥ 40 years, diagnosis of idiopathic PD, classification between stages II to IV on the modified Hoehn \& Yahr Scale, stable use of anti-parkinsonian pharmacological therapy, ability to walk independently with a walking speed ≤ 1.1 m/s (defined to screen individuals with gait impairments), and ability to use a single-point cane during walking without regular use of any type of assistive device since the diagnosis of PD. Participant will be randomly divided into two groups that will receive: (1) cane training and use (experimental group) or (2) global stretches and health education (time and attention-controlled group). The intervention will be provided in four sessions lasting 40 minutes each, spaced over 15 to 22 days. Additionally, individuals will be instructed to use a cane (experimental group) or perform stretching exercises (time and attention-controlled group) daily, starting from the first day of training. Assessments will be conducted at the beginning of the study (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up). 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. 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).
Conclusions: The results of the present study will provide information about the effects of cane training and use on the gait of individuals with PD who will have the opportunity to use the cane in their real-life context.
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
cognitive impairment, assessed by the Mini Mental State Examination
use deep brain stimulation,
had any other neurological, cardiopulmonary or musculoskeletal condition that may compromise the tests performance
Parallel
Cane
DeviceIndividuals will receive a single-point cane, individually adjusted to maintain each individual's elbow at approximately 30 degrees of flexion. Participants will be instructed to use the device on dominant side or the side with less impairment. The training with the cane will be carried out by a trained physiotherapist. The training protocol will include gait training with the cane on different surfaces and speeds. At the beginning of each training session, individuals will have the opportunity to address any questions they may have about using a cane in their daily life context. 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
static stretching and health education
Other interventionThe intervention for the control group will consist of 20 minutes of global static stretching and 20 minutes of guidance on general health care. The stretches will be performed in three sets of 30 seconds each, targeting different muscle groups. If a participant is unable to perform the self-stretches, the researchers responsible for implementing the intervention will provide assistance. The health education component will cover information on Parkinson's disease (PD) and fall prevention. 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.
Change from baseline in gait speed
Gait speed will be measured by the 10-Meter Walk Test following previously described protocols
Change from baseline in gait confidence
Gait confidence will be assessed using the Gait Efficacy Scale-Brazil (mGES-Brazil). The mGES-Brazil is a ten-item scale that assesses an individual's confidence while walking in challenging circumstances.
Change from baseline in step length and cadence
Step length and cadence will be assessed during the 10MWT following previously described protocols
Change from baseline in functional mobility
Functional mobility will be assessed using the Timed "Up Go" test (TUG) following previously described protocols
Change from baseline in freezing of Gait
Freezing of gait will be assessed by the Freezing of Gait Questionnaire (FOG-Q). This questionnaire has six items aimed at evaluating freezing during the gait in participants with PD. In addition to the questionnaire, the number and duration of freezing episodes that participants experience during the 10MWT and the TUG will be reported. The 10MWT and the TUG tests will be video recorded to allow detailed analysis of freezing episodes during the assessment.
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Federal University of Minas Gerais
Lead sponsor
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Collaborator
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais
Collaborator
