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The Integrate program for safe mobility in Parkinson's Disease.

Integrate: a randomised controlled trial of a tailored and multi factorial program for safe mobility in people with Parkinson's Disease.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000415101
Enrollment
29
Registered
2019-03-13
Start date
2019-07-01
Completion date
2023-01-31
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

As Parkinson's Disease (PD) progresses, people develop significant mobility limitations and falls despite optimal medical care. The objective of the research is to help people with advancing PD and their families to live better by maintaining safe mobility for longer. Many of the impairments commonly associated with PD contribute to mobility limitations, including impaired balance , freezing of gait and cognitive impairment. The proposed project aims to to determine if a 6 month home based environmental, behavioral and exercise multi factorial intervention for people with PD improves mobility and safe mobility behaviors. Secondary aims are to determine the effect of the program on walking quantity and quality, leg muscle strength, FOG, concern about falling, activities of daily living and care partner burden.

Interventions

The intervention will be a 6 month multi factorial home-based program (ie. multiple interventions tailored to the individual and targeting their mobility related goals) designed to improve for safe mobility and reduce falls in people with Parkinson's Disease. Participants will undertake the intervention in addition to their usual care. The intervention will consist of environmental modification, behavioral modification and exercise which will be delivered to participants in their homes by traine

The intervention will be a 6 month multi factorial home-based program (ie. multiple interventions tailored to the individual and targeting their mobility related goals) designed to improve for safe mobility and reduce falls in people with Parkinson's Disease. Participants will undertake the intervention in addition to their usual care. The intervention will consist of environmental modification, behavioral modification and exercise which will be delivered to participants in their homes by trained occupational therapists and physiotherapists. Participants will receive 8-12 therapy home visits over a 6 month period depending on their need. The components of the program will be designed in collaboration with the person with PD and any care partner. The ratio of physiotherapy and occupational therapy home visits will depend on each participants physical abilities, functional cognition, ability to engage with the different components of the intervention, identified goals and issues of safety. Participants will receive regular phone calls (at least 5 phone calls during the intervention period) to monitor progress and address any problems arising related to the intervention. The environmental and behavioural components of the program will be delivered as a home and community safety package. Strategies will be discussed with the participant (and any care partner) and implemented through the use of diaries and goal setting. Environmental adaptations to reduce falls risk will be introduced (eg. removal of clutter,improving lighting) and participants who display unsafe patterns of movement will be taught how to use cues and strategies to initiate and maintain safe movement. Situational cues will be used as prompts to reinforce goal directed behavior. Participants will be provided with a home safety booklet which will be adapted to their cognitive abilities and will outline recommendations. The booklets will be designed by the research team specifically for this trial. The home based exercise component of the program will be individually prescribed and delivered to participants in their homes by an experienced Physiotherapist and will include commonly used exercises for fall prevention (www.webb.org.au) and PD specific exercises available at www.physiotherapyexercises.com. These exercises are known remedial risk factors for falls in people with PD (ie. leg muscle weakness, poor standing balance and freezing of gait). Exercises will be prescribed to be performed in 30 minute sessions, between 3-5 times per week. In order to maximize efficiency and minimize adverse events, programs will be individually prescribed and progressed according to participants physical and cognitive abilities. Participants will be shown how to exercise with a stable support nearby if necessary. Exercises will also be taught to any care partner who will provide supervision and assistance (including appropriate cueing) as required. Participants and any care partner will be provided with an exercise booklet, designed by research staff specifically for the trial, which will include clear pictorial and simple written instructions, as well as precautions and instructions to advise study staff and /or their medical practitioner if they experience any major adverse effects from the exercise. They will also be provided with a log book to record completed exercises and any effects of the exercise (eg. muscle soreness).

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

At least 2 falls in the prior 6 months No change in Parkinson's Disease medications 2 weeks prior to commencing the study Ability to walk independently at least 10 meters with or without an aid. Participants with significant cognitive impairment (Montreal Cognitive assessment <19 or,a level of functional cognition that the researchers deem requires assistance to participate) will require a care partner who is willing to participate with them to assist them with the intervention.

Exclusion criteria

Medical conditions which would preclude or interfere with study safety and conduct. Severe cognitive impairment (Montreal Cognitive Assessment < 5 )

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026