Clinical trial NCT06950255: Effect of Training and Use of Cane on Gait in Individuals With Parkinson's Disease
Official title: Effect of a 3-week Program of Cane Training and Use on Gait of Individuals With Parkinson's Disease: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: assistive device
canes
mobility
gait
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais
First posted: 2025-04-30
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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
* ability to use a single-point cane during walking correctly and safely, and not being regular users of any type of assistive device since the diagnosis of PD.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in gait speed
timeFrame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Secondary outcomes:
measure: Change from baseline in gait confidence
timeFrame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
measure: Change from baseline in step length and cadence
timeFrame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
measure: Change from baseline in functional mobility
timeFrame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
measure: Change from baseline in freezing of Gait
timeFrame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
measure: Change from baseline in fear of falls
timeFrame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
measure: Satisfaction with using the cane
timeFrame: One month after the cessation of the intervention (8-week follow-up)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Christina DCM Faria, Doctor
role: PRINCIPAL_INVESTIGATOR
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