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

NCT06950255 | Recruiting

• 1 other identifier: CAAE: 75158123.2.0000.5149
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

assistive device; canes; mobility; gait

Outcome Measures

Primary Outcomes (1)

• Change from baseline in gait speed

  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 Outcomes (6)

• Change from baseline in gait confidence

  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

  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

  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

  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

  At basilene (week 0), post-intervention (after the 3-week intervention), and one month after the cessation of the intervention (8-week follow-up).

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Time and attention control group

SHAM COMPARATOR

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

Interventions

Cane DEVICE

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

Experimental group

static stretching and health education OTHER

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.

Time and attention control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• 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

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270901, Brazil

RECRUITING

Related Publications (7)

• Mehdizadeh M, Martinez-Martin P, Habibi SA, Fereshtehnejad SM, Abasi A, Niazi Khatoon J, Saneii SH, Taghizadeh G. Reliability and Validity of Fall Efficacy Scale-International in People with Parkinson's Disease during On- and Off-Drug Phases. Parkinsons Dis. 2019 Jan 2;2019:6505232. doi: 10.1155/2019/6505232. eCollection 2019.

  PMID: 30719277 BACKGROUND

• Keus S, Munneke M, Graziano M, et al. European Physiotherapy Guideline for Parkinson's disease. 2014; KNGF/ParkinsonNet, the Netherlands.

  BACKGROUND

• Avelino, P. R., Menezes, K. K. P. de, Nascimento, L. R., Faria-Fortini, I., Faria, C. D. C. de M., Scianni, A. A., & Teixeira-Salmela, L. F. (2018). Adaptação transcultural da Modified Gait Efficacy Scale para indivíduos pós-acidente vascular encefálico. Revista de Terapia Ocupacional Da Universidade de São Paulo, 29(3), 230-236. https://doi.org/10.11606/issn.2238-6149.v29i3p230-236

  BACKGROUND

• Mirelman A, Bonato P, Camicioli R, Ellis TD, Giladi N, Hamilton JL, Hass CJ, Hausdorff JM, Pelosin E, Almeida QJ. Gait impairments in Parkinson's disease. Lancet Neurol. 2019 Jul;18(7):697-708. doi: 10.1016/S1474-4422(19)30044-4. Epub 2019 Apr 8.

  PMID: 30975519 BACKGROUND

• Kader M, Jonasson SB, Iwarsson S, Odin P, Nilsson MH. Mobility device use in people with Parkinson's disease: A 3-year follow-up study. Acta Neurol Scand. 2018 Jul;138(1):70-77. doi: 10.1111/ane.12942. Epub 2018 Apr 16.

  PMID: 29658981 BACKGROUND

• Ni M, Hazzard JB, Signorile JF, Luca C. Exercise Guidelines for Gait Function in Parkinson's Disease: A Systematic Review and Meta-analysis. Neurorehabil Neural Repair. 2018 Oct;32(10):872-886. doi: 10.1177/1545968318801558. Epub 2018 Sep 28.

  PMID: 30265211 BACKGROUND

• Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.

  PMID: 33848468 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Canes; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christina DCM Faria, Doctor

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina DCM Faria, Doctor

CONTACT

+55 (31) 34097448; cdcmf@ufmg.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The collection will be performed by a previously trained examiner, blinded to the allocation of groups. All participants will be instructed not to comment on information about the training received. The therapist responsible for delivering the intervention will be blinded to the results of participants' assessments All statistical analyzes will be performed by an independent examiner, blinded to all procedures performed in the study, including with regard to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)