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L'essai clinique NCT05510739 (STEPS-PD) pour Maladie de Parkinson, Activité physique, eSanté, Troubles neurologiques de la marche est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Support for Physical Activity in Everyday Life With Parkinson's Disease (STEPS-PD)

Actif, pas en recrutement
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L'étude clinique NCT05510739 (STEPS-PD) est un essai interventionnel pour Maladie de Parkinson, Activité physique, eSanté, Troubles neurologiques de la marche. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 19 septembre 2022 et vise à recruter 140 participants. Dirigé par Stiftelsen Stockholms Sjukhem, l'essai devrait être terminé d'ici le 1 juillet 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 juillet 2025.
Résumé succinct
This study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using eHealth methods, among people with Parkinson's disease. The intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. The main hypothesis is that unsupervised motor-cognitive training in the home environment using eHealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.
Description détaillée
This randomised controlled trial will investigate the efficacy of a motor-cognitive exercise program in the home environment, over a 10-week period, on physical function, and motor-cognitive dual task function as well as physical activity behavior in everyday life. A follow-up assessment comprising health-related questionnaires and physical activity monitoring will be conducted at one year post-intervention. Participants will be recruited through Stockholms sjukhem foundation, Karolinska University and via announcements in relevant forums like for instance the Swedish Parkinson Association. Consenting participants will be randomized to the eHealth Intervention group or the control group condition. Block randomization will be achieved using a computerized random sequence generator. Blinded assessors will perform the pre- and post-intervention testing of physical performance.

The ultimate aim of this project is to provide people with PD with continual long-term and evidence-based rehabilitation in their everyday lives using mobile health technology, to support their self- management and increase their quality of life.

Titre officiel

Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology

Conditions
Maladie de ParkinsonActivité physiqueeSantéTroubles neurologiques de la marche
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • STEPS-PD
  • StockholmsSjukhem
Numéro NCT
NCT05510739
Date de début (réel)
2022-09-19
Dernière mise à jour publiée
2025-07-02
Date de fin (estimée)
2025-07
Inscription (estimée)
140
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalMotor-cognitive exercise using eHealth
10-week eHealth based motor-cognitive home training using digital tablets. Cognitive behavioural strategies to promote increase in physical activity levels (walking). Participants will be encouraged to perform 150 minutes of home exercise per week, occurring on three non-consecutive days.
Motor-cognitive Home Exercise Supported by Ehealth Technology
10-week, individualized and progressive exercise program targeting functional strength, cardiovascular fitness and physical activity levels. Cognitive exercises are incorporated with motor exercises as an adjunct to the intervention.
Comparateur actifIndividualised home training program
Participants will receive an individualized home exercise program on paper and one instructional session. They will receive written instructions on performing the program 2-3 times weekly and instructions on exercise progression. They will receive no support during the 10-week period.
Individualized Home Exercise Program
Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
The six minute walk test
This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes.
Change in balance performance at 10 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Gait parameters during single and dual-task conditions
Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors
Change at 10 weeks
Quality of life questionnaires
PDQ-39 is disease specific quality of life questionnaire. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100
Change at 10 weeks and one year post-intervention
Physical activity measured with accelerometers
Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity)
Change at 10 weeks and one year post-intervention
Dual-task ability during walking
Captured using the Auditory Stroop test during walking and expressed as percentage error of the task
Change at 10 weeks
Balance ability
MiniBest test. Scoring 0-28, lower scores = greater balance impairment
Change at 10 weeks
Executive function
Trail making test A \& B. Expressed as time required to perform the test (seconds)
Change at 10 weeks
Balance Confidence
The Activities-specific Balance Confidence scale is a measure of confidence performing in various activities without losing balance or experiencing unsteadiness. A 16-item self-report measure with items rated on a rating scale that ranges from 0-100. A higher score indicates higher balance confidence.
Change at 10 weeks and one year post-intervention
Health-related Quality of Life
The EQ-5D is a two-part instrument that measures health-related quality of life. It examines 5 domains of quality of life: mobility, self-care, daily activities, pain, anxiety/depression. It comprises 5 questions and a visual scale.
Change at 10 weeks and one year post-intervention
Exercise Self-Efficacy
The Exercise Self-Efficacy Scale is an instrument examining confidence regarding carrying out regular physical activities and exercise. Questions are answered on a 4-point rating scale. A higher score indicates greater confidence.
Change at 10 weeks and one year post-intervention
Walking ability
The Walk-12 questionnaire examines limitations in walking ability. It consists of 12 questions answered on either a 3-point or 5-point rating scale.
Change at 10 weeks and one year post-intervention
Hospital Anxiety and Depression Scale
A 14-item measure designed to reflect the state of generalised anxiety and depression. The respondent rates each item on a 4-point scale. Higher scores indicate greater levels of anxiety or depression.
Change at 10 weeks and one year post-intervention
Life Space Assessment
The LSA is a self-report measure of the frequency of independent mobility across 5 life-space levels. Higher scores indicate more life-space and movement throughout the community.
Change at 10 weeks and one year post-intervention in only the final cohort of participants
Global Positioning System
GPS monitors collecting participant daily location and movement data via latitude and longitude coordinates collected throughout waking hours.
Change at 10 weeks and one year post-intervention in only the final cohort of participants
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
50 Years
Sexes éligibles
Tous
  • Diagnosis of idiopathic Parkinson´s disease
  • Hoehn & Yahr (Parkinsons progression scale) 2-3
  • ≥ 50 years of age
  • Able to ambulate indoors without mobility aid
  • Able to walk continually with/without a walking aid for at least 6 minutes

  • Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points
  • Major problems with freezing and/or two or more falls in the month previous to inclusion
  • Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise
  • Impaired vision and/or impaired communication which hinders participation
  • No internet connection in the home
Stiftelsen Stockholms Sjukhem logoStiftelsen Stockholms Sjukhem
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1 Centres de l'essai dans 1 pays
Stockholms sjukhem, Stockholm, 141 83, Sweden