Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing

NCT05019469 | Completed

• 2 other identifiers: IRAS_21672318/SW/0235
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot/feasibility study is to test if delivering rhythmic vibration cues to the lower legs, specifically in response to gait defects (rather than continuously), can improve walking quality and overcome gait freezing in Parkinson's disease. During the study, people with Parkinson's disease that suffer from regular (daily) gait freezing will undertake a series of walking/activity circuits, receiving continuous cueing, responsive cueing (delivered in response to gait freezing), no cueing and no device. Vibration cueing is provided by a non-invasive wearable device prototyped at the University of Oxford, worn on the lower legs during 3 circuits. A series of walking metrics will be analysed.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Gait freezing; Cueing; Gait

Outcome Measures

Primary Outcomes (1)

• Step frequency

  The primary objective is to test if gait-freeze initiated vibration cues, provided at the lower-leg, can improve gait/walking quality in PD patients. The primary outcome measure will be cadence (step frequency) with other gait measurements including frequency and duration of gait freeze events, continuous walking time, left/right rhythm and stride length. Measurements extracted from video data collected during 1 hour study sessions. Change in these measurements assessed between cued (intervention) and no-cue (no intervention) walking circuits for each participant.

  Data collected during 1 hour sessions up to study completion.

Secondary Outcomes (1)

• Automated gait freeze detection

  Movement data collected during 1 hour sessions up to study completion.

Study Arms (1)

Single arm of study

EXPERIMENTAL

Single Arm. During each study session the participant undertakes 4 walking/activity circuits. During each circuit the participant receives either continuous cueing, responsive cueing (delivered in response to gait freezing), no cueing and no device. The ordering of the interventions/circuits are systematically alternated for each participant.

Device: Rhythmic vibration cueing (lower leg)

Interventions

Rhythmic vibration cueing (lower leg) DEVICE

A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.

Single arm of study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Participant is fluent in English.
• Participant is aged 18-90 years inclusive
• Patients in whom the clinical diagnosis is stated as idiopathic Parkinson's disease or Parkinson's disease (PD).
• Participant self-reports a history of daily gait freezing (several times a day), but should be able to stand and walk freely for short periods with minimal assistance.
• Participant has no evidence for significant cognitive impairment.
• In the investigator's opinion, is willing and able to comply with all trial requirements.

You may not qualify if:

• Participant has a medical or psychiatric illness that would interfere with completing initial and follow up assessments.
• Participant has severe mental impairment, dementia or psychosis determined either by a prior diagnosis by a medical professional with relevant expertise, or by subjective assessment by the research team during the pre-study questionnaire (e.g. an inability to comprehend questions).
• Active participation in a clinical drug trial.
• Female who is pregnant, lactating or planning pregnancy during the course of the investigation. This information will be provided to us by the patient during recruitment screening.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Patients with frequent (daily) falls at home or out of home, or who demonstrate a high fall risk during the study.
• Patients with atypical parkinsonism (eg MSA, PSP, CBD).
• Patients who have had Deep Brain Stimulation for their PD.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

The Bosworth Clinic

Cassington, Oxfordshire, OX29 4DS, United Kingdom

Location

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

• James Cantley, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 24, 2021
• Study Start: February 13, 2019
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: August 24, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)