Remotely Prescribed and Monitored Home-based Gait-and-balance Augmented Reality Exergaming for People With Parkinson's Disease.

Parkinson Disease Clinical Trial

Official title:

Remotely Prescribed and Monitored Home-based Gait-and-balance Therapeutic Exergaming Using Augmented Reality (AR) Glasses: Protocol for a Clinical Feasibility Study in People With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605249
• Other study ID #: NL82441.100.22
• Status: Completed
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: September 2023
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite optimal treatment with medication, people with Parkinson's disease (PD) still experience symptoms and secondary complications. Physiotherapy has long been recognized as one of the leading treatments in PD for slowing progression of the disease and retaining a higher quality of life for longer. Physiotherapy includes, among other things, training motor functions e.g., gait, balance and strength training and encourages physical activity. Exercise is an important part of healthy living for everyone, but for people with PD, exercise is medicine. Studies even suggest that exercise may slow down disease progression. Another way of improving PD motor symptoms, such as festination and freezing of gait (FOG), in a more direct way is by sensory cueing. Cueing is defined as the application of spatial or temporal external stimuli to help initiate, or facilitate gait, and can be presented as acoustic, visual, or tactile stimuli. It has been well known for many years that sensory cueing is effective and there has been extensive research on the topic.

Cue X is a new product developed by Strolll Limited (www.strolll.co) that applies the existing proven principles of exercise and sensory cueing for PD onto augmented-reality (AR) headsets implemented in two modules: movement training and movement assistance. The movement training module is designed to train gait and balance in a gamified manner to maximize training compliance. With this clinical feasibility study, the investigators want to examine the feasibility and potential efficacy of the Cue X movement training module to train gait and balance of people with PD in their home environment.

Description:

The primary objective of this clinical feasibility study in people with PD is to evaluate the feasibility and potential efficacy of home-based gamified AR gait-and-balance exercises with Cue X. Secondary objectives of this study are to validate the gait-modifying effects of Cue X AR cueing and to quantify the test-retest reliability and concurrent validity of (clinical) outcome measures of gait and balance, as derived from AR headset data.

With these primary and secondary objectives, the study will give insight into 1) the feasibility and potential efficacy of Cue X for home-based gamified AR gait-and-balance exercises, 2) the most effective type of AR cueing and 3) the best parameters for feedback, reporting and sample-size calculations for a subsequent effect study with Cue X. Furthermore, the study will inform about the best AR headset for these purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have command of the Dutch language

• Diagnosed with PD according to the UK PD Brain Bank criteria (stages 2-4 on the Hoehn and Yahr scale)

• Bothersome gait or balance impairments (i.e., negatively affecting their ability to perform their usual daily activities)

Exclusion Criteria:

• Inability to comply with the protocol, i.e. additional neurological diseases and/or orthopaedic problems seriously interfering with gait function, insufficient physical capacity or cognitive/communicative inability (as observed by the researcher or clinician) to understand instructions and participate in the tests

• (Severe) visual or hearing impairments (after corrective aids)

• (Severe) visual hallucinations or illusions

• Inability to walk independently for 30 minutes

• No stable dosage of medication

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Cue X
The Cue X movement training module includes several games that can be performed in someone's home environment. The games are designed based on known physiotherapy guidelines and evidence for improving motor symptoms for people with PD and delivered in AR. Some of the games also have integrated cueing to allow people with more severe mobility impairments to participate. Feedback of performance can be given using the movement data of the AR headsets.

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Amsterdam	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
VU University of Amsterdam	Strolll, Ltd

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Lim I, van Wegen E, de Goede C, Deutekom M, Nieuwboer A, Willems A, Jones D, Rochester L, Kwakkel G. Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. Clin Rehabil. 2005 Oct;19(7):695-713. doi: 10.1191/0269215505cr906oa. — View Citation

Lindop, F., & Skelly, R. (Eds.). (2021). Parkinson's Disease: An Interdisciplinary Guide to Management. Elsevier Health Sciences.

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. Erratum In: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126. — View Citation

Nieuwboer A. Cueing for freezing of gait in patients with Parkinson's disease: a rehabilitation perspective. Mov Disord. 2008;23 Suppl 2:S475-81. doi: 10.1002/mds.21978. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40. — View Citation

Rocha PA, Porfirio GM, Ferraz HB, Trevisani VF. Effects of external cues on gait parameters of Parkinson's disease patients: a systematic review. Clin Neurol Neurosurg. 2014 Sep;124:127-34. doi: 10.1016/j.clineuro.2014.06.026. Epub 2014 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Scale (SUS) [Usability]	A 10-item questionnaire to measure usability of the Cue X training module, answered on a 5 point Likert scale (1 strongly disagree - 5 strongly agree). Minimum - maximum score: 10 - 50. Higher scores imply better usability of the Cue X software.	After 6-week training
Primary	Number of adverse events [safety]	To measure safety of the Cue X training module	During 6-week training
Primary	Side effects as reported by participants [safety]	To measure safety of the Cue X training module	During 6-week training
Primary	Adherence to the training programme	Actual exercise time as a percentage of prescribed exercise time. The prescribed exercise time is 30 minutes, 5 days a week.	During 6-week training
Primary	Patient-reported outcome measures (PROMs)	An example is quality of life as measured by the Parkinson's Disease Questionnaire (PDQ-39). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living, among which quality of life. Higher scores on one of the dimensions indicate worse well-being on that specific dimension.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Primary	Patient-reported experience measures (PREMs)	Perceived effectiveness of the Cue X training programme through Likert scale reporting and semi-structured interview questions during weekly phone calls and a post-intervention interview.	After 6-week training
Primary	Mini Balance Evaluation Systems Test (Mini-BESTest) [Gait-and-balance outcome measures]	To measure balance and postural control. Minimum - maximum score: 0 - 28. Higher scores indicate better balance and postural control.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Primary	Timed Up-and-Go test (TUG) [Gait-and-balance outcome measures]	To measure functional gait. Higher scores indicate worse functional gait.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Primary	Lindop Parkinson's Physiotherapy Assessment Scale (LPPAS) [Gait-and-balance outcome measures]	To measure gait mobility. Higher scores indicate better gait mobility. Minimum - maximum score: 0 - 18	Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Primary	Targeted walking-related fall-risk assessment as measured by the Interactive Walkway	Targeted walking-related fall-risk assessment based on outcome measures of walking adaptability as determined with the Interactive Walkway (obstacle avoidance margins and success rates and stepping accuracy and walking speed during goal-directed stepping)	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Five Times Sit to Stand Test (FTSTS)	To measure lower extremity strength [standard clinical tests and questionnaires]. Higher scores indicate worse lower extremity strength.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	New Freezing of Gait Questionnaire (NFOGQ)	To measure freezing of gait severity [standard clinical tests and questionnaires]. Higher scores indicate the severity and the burden of freezing of gait in daily life is worse. Minimum - maximum score: 0 - 28.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Movement Disorders Society Unified Parkinson Disease Rating Scale (UPDRS)	To measure overall PD severity [standard clinical tests and questionnaires]. The UPDRS consists of three segments: I) Mentation, Behavior and Mood, II) Activities of Daily Living, and III) Motor Examination. Higher scores on these segments and higher total scores indicate more severe PD symptoms.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Activities-Specific Balance Confidence Scale (ABC)	To measure balance confidence [standard clinical tests and questionnaires]. Minimum - maximum score: 0 - 1600. Higher scores indicate more confidence in performing daily activities without losing balance.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Falls Efficacy Scale International (FES-I)	To measure fear of falling [standard clinical tests and questionnaires]. Minimum - maximum score: 16 - 64. Higher scores indicate that the participant is more concerned about falling.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Physical Activity Scale for the Elderly (PASE)	To measure physical activity [standard clinical tests and questionnaires]. Higher scores indicate greater physical activity.	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Gait speed [Gait-modifying ability and data quality]	Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores	Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Cadence [Gait-modifying ability and data quality]	Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Step length [Gait-modifying ability and data quality]	Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary	Step time [Gait-modifying ability and data quality]	Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores	Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)