A Randomized Clinical Trial to Evaluate a Digital Therapeutic to Enhance Gait Function in Individuals With Parkinson's Disease.

Humans Parkinson Disease Single-Blind Method Postural Balance Gait Exercise Therapy Gait Disorders, Neurologic / etiology
Parkinsons digital therapeutic dual-task gait postural stability

Journal

Neurorehabilitation and neural repair
ISSN: 1552-6844
Titre abrégé: Neurorehabil Neural Repair
Pays: United States
ID NLM: 100892086

Informations de publication

Date de publication:
09 2023
Historique:
medline: 27 9 2023
pubmed: 19 7 2023
entrez: 19 7 2023
Statut: ppublish

Résumé

Postural instability and gait dysfunction (PIGD) is a cardinal symptom of Parkinson's disease (PD) and is exacerbated under dual-task conditions. Dual-task training (DTT), enhances gait performance, however it is time and cost intensive. Digitizing DTT via the Dual-task Augmented Reality Treatment (DART) platform can expand the availability of an effective intervention to address PIGD. The aim of this project was to evaluate DART in the treatment of PIGD in people with PD compared to a Traditional DTT intervention. It was hypothesized that both groups would exhibit significant improvements in gait, and the improvements for the DART group would be non-inferior to Traditional DTT. A single-blind randomized controlled trial was conducted with 47 PD participants with PIGD. Both groups completed 16 therapeutic sessions over 8 weeks; the DART platform delivered DTT via the Microsoft HoloLens2. Primary outcomes included clinical ratings and single- and dual-task gait biomechanical outcomes. Clinical measures of PD symptoms remained stable for DART and Traditional DTT groups. However, both groups exhibited a significant increase in gait velocity, cadence, and step length during single- and multiple dual-task conditions following the interventions. Improvements in gait velocity in the DART group were non-inferior to Traditional DTT under the majority of conditions. Non-inferior improvements in gait parameters across groups provides evidence of the DART platform being an effective digital therapeutic capable of improving PIGD. Effective digital delivery of DTT has the potential to increase use and accessibility to a promising, yet underutilized and difficult to administer, intervention for PIGD. ClinicalTrials.gov Dual-task Augmented Reality Treatment for Parkinson's Disease (DART) NCT04634331; posted November 18, 2020.

Sections du résumé

BACKGROUND
Postural instability and gait dysfunction (PIGD) is a cardinal symptom of Parkinson's disease (PD) and is exacerbated under dual-task conditions. Dual-task training (DTT), enhances gait performance, however it is time and cost intensive. Digitizing DTT via the Dual-task Augmented Reality Treatment (DART) platform can expand the availability of an effective intervention to address PIGD.
OBJECTIVE
The aim of this project was to evaluate DART in the treatment of PIGD in people with PD compared to a Traditional DTT intervention. It was hypothesized that both groups would exhibit significant improvements in gait, and the improvements for the DART group would be non-inferior to Traditional DTT.
METHODS
A single-blind randomized controlled trial was conducted with 47 PD participants with PIGD. Both groups completed 16 therapeutic sessions over 8 weeks; the DART platform delivered DTT via the Microsoft HoloLens2. Primary outcomes included clinical ratings and single- and dual-task gait biomechanical outcomes.
RESULTS
Clinical measures of PD symptoms remained stable for DART and Traditional DTT groups. However, both groups exhibited a significant increase in gait velocity, cadence, and step length during single- and multiple dual-task conditions following the interventions. Improvements in gait velocity in the DART group were non-inferior to Traditional DTT under the majority of conditions.
CONCLUSION
Non-inferior improvements in gait parameters across groups provides evidence of the DART platform being an effective digital therapeutic capable of improving PIGD. Effective digital delivery of DTT has the potential to increase use and accessibility to a promising, yet underutilized and difficult to administer, intervention for PIGD.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov Dual-task Augmented Reality Treatment for Parkinson's Disease (DART) NCT04634331; posted November 18, 2020.

Identifiants

DOI: 10.1177/15459683231184190 PMID: 37465959
pubmed: 37465959
doi: 10.1177/15459683231184190
doi:

Banques de données

ClinicalTrials.gov
['NCT04634331']

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

603-616

Auteurs

Jay L Alberts (JL)

Department of Biomedical Engineering, Cleveland Clinic, Lerner Research Institute, Cleveland, OH, USA.
Center for Neurological Restoration, Cleveland Clinic, Neurological Institute, Cleveland, OH, USA.

Ryan D Kaya (RD)

Center for Neurological Restoration, Cleveland Clinic, Neurological Institute, Cleveland, OH, USA.
ORCID: 0000-0002-6964-888X

Amanda L Penko (AL)

Department of Biomedical Engineering, Cleveland Clinic, Lerner Research Institute, Cleveland, OH, USA.

Matthew Streicher (M)

Department of Biomedical Engineering, Cleveland Clinic, Lerner Research Institute, Cleveland, OH, USA.
ORCID: 0000-0002-6319-5779

Eric M Zimmerman (EM)

Center for Neurological Restoration, Cleveland Clinic, Neurological Institute, Cleveland, OH, USA.

Sara Davidson (S)

Center for Neurological Restoration, Cleveland Clinic, Neurological Institute, Cleveland, OH, USA.

Benjamin L Walter (BL)

Center for Neurological Restoration, Cleveland Clinic, Neurological Institute, Cleveland, OH, USA.
ORCID: 0000-0002-8323-6873

Anson B Rosenfeldt (AB)

Department of Biomedical Engineering, Cleveland Clinic, Lerner Research Institute, Cleveland, OH, USA.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › A Randomized Clinical Trial to Evaluate a...
questionsmedicales.fr › Maladies du système nerveux › Maladies neurodégénératives › Maladie de Parkinson › A Randomized Clinical Trial to Evaluate a...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en simple aveugle › A Randomized Clinical Trial to Evaluate a...
questionsmedicales.fr › Phénomènes physiologiques de l'appareil locomoteur et du système nerveux › Phénomènes physiologiques du système nerveux › Sensation › Proprioception › Équilibre postural › A Randomized Clinical Trial to Evaluate a...
questionsmedicales.fr › Phénomènes physiologiques de l'appareil locomoteur et du système nerveux › Phénomènes physiologiques du système locomoteur › Mouvement › Locomotion › Démarche › A Randomized Clinical Trial to Evaluate a...
questionsmedicales.fr › Thérapeutique › Techniques de physiothérapie › Traitement par les exercices physiques › A Randomized Clinical Trial to Evaluate a...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Troubles neurologiques de la marche › A Randomized Clinical Trial to Evaluate a...