NCT06950255Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 11.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 26 (tervezett)
- Első benyújtás
- 2025. ápr. 22.
- Kezdés
- 2025. máj. 1.
- Elsődleges befejezés
- 2026. szept. 30.
- Fő szponzor
- Federal University of Minas Gerais
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT06950255
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 26
- 2025. máj. 1. és az elsődleges befejezés (2026. szept. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- cognitive impairment, assessed by the Mini Mental State Examination
- had any other neurological, cardiopulmonary or musculoskeletal condition that may compromise the tests performance
Egyéb
- use deep brain stimulation,
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Federal University of Minas Gerais Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Belo Horizonte | Brazília | Toboroz |
Kapcsolódó publikációk
- Immediate effects and perceptions of cane use on mobility in individuals with Parkinson's disease.Disabil Rehabil · 2026 · PMID 42633763
- 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.PLoS One · 2026 · PMID 41990090
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