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NCT06950255Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
26 (estimated)
First submitted
22 Apr 2025
Start date
1 May 2025
Primary completion date
30 Sept 2026
Lead sponsor
Federal University of Minas Gerais
NCT number
NCT06950255

What you commit to

  • Study type: Interventional
  • Planned participants: 26
  • From 1 May 2025 to the primary completion date, 30 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • cognitive impairment, assessed by the Mini Mental State Examination
  • had any other neurological, cardiopulmonary or musculoskeletal condition that may compromise the tests performance

Other

  • use deep brain stimulation,

Who the study is looking for

  • 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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Federal University of Minas Gerais
Coordinator of this site? Confirm its status
Belo HorizonteBrazilRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.