Cueing-assisted Gamified Augmented-reality Gait-and-balance Rehabilitation at Home for People With Parkinson's Disease

NCT06590987 | Completed

• 1 other identifier: NL86191.100.24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Physiotherapy in the clinic is highly recommended for improving gait, balance and falls risk in people with Parkinson's disease. In addition, technology may help boost unsupervised exercise hours at home. Strolll is an augmented-reality (AR) neurorehabilitation platform for delivering gait-and-balance exercises onto AR glasses that can be performed under direct supervision of the therapist in the clinic, but also independently at home. Strolll AR also has the option to integrate AR cueing in gait-and-balance exercises to assist people with more severe mobility impairments in performing the exercises. The objective of this pragmatic randomized controlled trial (RCT) on Strolll AR is to examine its clinical feasibility and effectiveness for improving indicators of gait, balance and falls risk. A secondary objective is to evaluate procedures for tailoring assistive AR cues. Methods: 80-100 people with Parkinson's disease (Hoehn and Yahr stages 1-3) with gait and/or balance impairments will participate in this study. This study is a pragmatic RCT in which all participants follow the same procedure. After a baseline assessment (T0), participants will start with a 6-week usual care control period, followed by a midterm assessment (T1). Subsequently, participants will undergo two weeks of in-clinic familiarization with Strolll AR. Then, participants will start with the 6-week Strolll AR intervention at home, followed by a final in-clinic assessment (T2). The primary study parameters are feasibility (i.e., safety, adherence, performance and user experience) and effectiveness for improving indicators of gait, balance and falls risk. For the statistical analyses on effectiveness, participants will be allocated to control (using T0-T1 change data) or intervention (using T1-T2 change data) groups using multiple (n=20) randomizations. Recruitment started in May 2024 and the last T2 assessment is expected in January 2025. Discussion: The design of this particular pragmatic RCT will demonstrate feasibility and effectiveness in a real-world setting and in a representative population. Strolll AR may facilitate the transition from supervised care in the clinic to independent care at home, providing a platform for delivering individualized treatment, assisted with AR cues when deemed beneficial, for improving gait, balance and falls risk in people with Parkinson's disease.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Timed Up-and-Go test (s)

  Evaluating the effectiveness of Strolll AR

  Change between baseline, midterm and final assessment (over a period of 14 weeks, which includes 6 weeks usual care and an 8-week Strolll AR intervention [clinic and home])

Secondary Outcomes (9)

• 10-meter walk test (s)

  Change between baseline, midterm and final assessment (over a period of 14 weeks, which includes 6 weeks usual care and an 8-week Strolll AR intervention [clinic and home])

• Five Times Sit to Stand Test (s)

  Change between baseline, midterm and final assessment (over a period of 14 weeks, which includes 6 weeks usual care and an 8-week Strolll AR intervention [clinic and home])

• Mini Balance Evaluation Systems Test

  Change between baseline, midterm and final assessment (over a period of 14 weeks, which includes 6 weeks usual care and an 8-week Strolll AR intervention [clinic and home])

• Falls Efficacy Scale International

  Change between baseline, midterm and final assessment (over a period of 14 weeks, which includes 6 weeks usual care and an 8-week Strolll AR intervention [clinic and home])

• Safety (i.e. number of adverse events due to Strolll AR)

  During the 8-week Strolll AR intervention

Other Outcomes (10)

• Age (years)

  Baseline assessment, week 1

• Gender (male/female/other)

  Baseline assessment, week 1

• Disease duration (years)

  Baseline assessment, week 1

Study Arms (2)

Usual care

NO INTERVENTION

After a baseline assessment of standard clinical tests, participants will start with a 6-week usual care control period. After 6 weeks, participants undergo the midterm assessments.

Strolll AR

EXPERIMENTAL

After 6 weeks, participants undergo the midterm assessments. Then, participants will start with the 8-week Strolll AR intervention (i.e., 2 weeks of practice supervised in the clinic and 6 weeks of training independently at home) and will receive a final assessment hereafter.

Device: Strolll AR

Interventions

Strolll AR DEVICE

Strolll AR is an augmented-reality (AR) neurorehabilitation platform for delivering gait and balance exercises (assisted with cues when deemed beneficial) for Parkinson's disease onto state-of-the-art AR glasses.

Strolll AR

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

To be eligible to participate, a person must meet the following criteria: * 21 years or older * have command of the Dutch language * diagnosed with Parkinson's disease according to the UK Parkinson's Disease Brain Bank criteria (stages 1-3 on the Hoehn and Yahr scale) * bothersome gait or balance impairments (i.e., negatively affecting their ability to perform their usual daily activities as indicated by the person with Parkinson's disease and/or their therapist). A potential participant who meets any of the following criteria will be excluded from participation: * inability to comply with the protocol, i.e. additional neurological diseases and/or orthopedic problems seriously interfering with gait function * insufficient physical capacity to safely perform the intervention (e.g., frequent faller) or severe cognitive impairments (as observed by the therapist) * visual or hearing impairments (after corrective aids) * inability to walk independently for 30 minutes (in bouts of 5-10 minutes) * severe visual hallucinations or illusions * no stable dosage of medication. Finally, in case potential participants are susceptible to hallucinations, have a history of seizures, have deep brain stimulation, or a pacemaker, it should be discussed with their therapist if they can participate, as per Strolll's Instructions For Use (DOC-IFU-00021 (NL), Revision 01, Date of Issue 06 2024).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

Location

Related Publications (7)

• Geerse DJ, Coolen B, Roerdink M. Quantifying Spatiotemporal Gait Parameters with HoloLens in Healthy Adults and People with Parkinson's Disease: Test-Retest Reliability, Concurrent Validity, and Face Validity. Sensors (Basel). 2020 Jun 5;20(11):3216. doi: 10.3390/s20113216.

  PMID: 32517076 BACKGROUND

• Geerse DJ, Coolen B, van Hilten JJ, Roerdink M. Holocue: A Wearable Holographic Cueing Application for Alleviating Freezing of Gait in Parkinson's Disease. Front Neurol. 2022 Jan 10;12:628388. doi: 10.3389/fneur.2021.628388. eCollection 2021.

  PMID: 35082741 BACKGROUND

• Lim LI, van Wegen EE, de Goede CJ, Jones D, Rochester L, Hetherington V, Nieuwboer A, Willems AM, Kwakkel G. Measuring gait and gait-related activities in Parkinson's patients own home environment: a reliability, responsiveness and feasibility study. Parkinsonism Relat Disord. 2005 Jan;11(1):19-24. doi: 10.1016/j.parkreldis.2004.06.003.

  PMID: 15619458 BACKGROUND

• McAuley JH, Daly PM, Curtis CR. A preliminary investigation of a novel design of visual cue glasses that aid gait in Parkinson's disease. Clin Rehabil. 2009 Aug;23(8):687-95. doi: 10.1177/0269215509104170. Epub 2009 Apr 29.

  PMID: 19403552 BACKGROUND

• Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I. Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. doi: 10.1136/jnnp.200X.097923.

  PMID: 17229744 BACKGROUND

• Snijders AH, Jeene P, Nijkrake MJ, Abdo WF, Bloem BR. Cueing for freezing of gait: a need for 3-dimensional cues? Neurologist. 2012 Nov;18(6):404-5. doi: 10.1097/NRL.0b013e31826a99d1.

  PMID: 23114676 BACKGROUND

• Geerse DJ, Hoogendoorn EM, van Doorn PF, van Bergem JS, van Dam AT, Hardeman LES, Roerdink M. Cueing-assisted gamified augmented-reality gait-and-balance rehabilitation at home for people with Parkinson's disease: protocol of a pragmatic randomized controlled trial implemented in the clinical pathway. Front Neurol. 2025 Feb 24;16:1512409. doi: 10.3389/fneur.2025.1512409. eCollection 2025.

  PMID: 40066314 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Melvyn Roerdink, PhD

  Department of Human Movement Sciences, Vrije Universiteit Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Model Details: Fully blinded two-armed pragmatic Randomized Controlled Trial (RCT). In this particular pragmatic RCT all participants follow the same T0-control-T1-intervention-T2 procedure, suitable for both between-groups and within-subjects comparisons of the Strolll AR intervention effects as well as for evaluating its clinical feasibility. With regard to the between-groups comparison, participants will be allocated to control (using T0-T1 change data) or intervention (using T1-T2 change data) groups using multiple (n=20) two-armed randomizations. The randomization will be predefined by an independent person using a Matlab script, locked with a date and timestamp, and kept concealed from participants, therapists and researchers. After the final T2 assessment of the last participant, the 20 randomizations of participants over control and intervention groups will be revealed to the researchers and applied in the data analysis.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: September 19, 2024
• Study Start: April 18, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 27, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

NL (1)