Effect of Training and Use of Cane on Gait in Individuals With Parkinson's Disease

June 9, 2026 updated by: Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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). 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).

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christina DCM Faria, Doctor
  • Phone Number: +55 (31) 34097448
  • Email: cdcmf@ufmg.br

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31270901
        • Recruiting
        • Federal University of Minas Gerais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
After allocation, 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 mobility activities. To enhance adherence, participants will receive telephone follow-ups between sessions aimed at monitoring and encouraging device use.
Device: Cane

Individuals 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
Sham Comparator: Time and attention control group
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.
Other: static stretching and health education

The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in gait speed
Time Frame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Gait speed will be measured by the 10-Meter Walk Test following previously described protocols
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in gait confidence
Time Frame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
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.
At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Change from baseline in step length and cadence
Time Frame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Step length and cadence will be assessed during the 10MWT following previously described protocols
At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Change from baseline in functional mobility
Time Frame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Functional mobility will be assessed using the Timed "Up Go" test (TUG) following previously described protocols
At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Change from baseline in freezing of Gait
Time Frame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
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.
At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Change from baseline in fear of falls
Time Frame: At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Fear of falls will be assessed by the Falls Efficacy Scale - International (FES-I). This questionnaire has 16 items that assess the individual's concerns about the possibility of falling while carrying out different daily tasks
At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).
Satisfaction with using the cane
Time Frame: One month after the cessation of the intervention (8-week follow-up)
Satisfaction regarding the use of the cane will be assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). The questionnaire has 12 items, scored from zero to five, where higher scores reflect greater participant satisfaction with assistive technology.
One month after the cessation of the intervention (8-week follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais

Investigators

  • Principal Investigator: Christina DCM Faria, Doctor, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 75158123.2.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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