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Movement DisordersSTEPWISENCT06692387

A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life: Pilot Study

A study testing Step count increase with the use of a motivational application in people with Movement Disorders and Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this pilot randomized controlled trial is to test whether it's feasible to increase participants' step counts within four weeks with a developed motivational smartphone application. If this is feasible, then we can proceed to test the app in a large, long-term randomized clinical trial. Read more about this study

Who is it for?
Any age
Conditions the study is for
Movement Disorders, Parkinson Disease
What is being tested?
Step count increase with the use of a motivational application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
2 Nov 2020to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • idiopathic PD
  • Hoehn and Yahr 1-3
  • able to understand the Dutch language
  • able to walk independently
  • less than 30 minutes of sports/outdoor activities per day (LASA Physical Activity Questionnaire, LAPAQ)
  • less than 7,000 steps/day during 1-week baseline

Who cannot join

  • weekly falls in the previous 3 months
  • medical conditions that hamper mobility
  • living in a nursing home
  • cognitive impairments that hamper use of the motivational app on the smartphone (Montreal Cognitive Assessment, MoCA <26)
  • not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud university medical center

    Nijmegen, Gelderland, 6500 HB

Other trials in Netherlands

About this study

Official title: STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life - Pilot Study

The aim of this pilot randomized controlled trial is to test whether it's feasible to increase participants' step counts within four weeks with a developed motivational smartphone application. If this is feasible, then we can proceed to test the app in a large, long-term randomized clinical trial.

Read the detailed description

Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.

Objective: The aim of this pilot study is to investigate whether the developed smartphone app can increase physical activity in people with PD for a short period of time (one month). The secondary aim is to study the usability and enjoyment of the app and the potential effects of an increase in physical activity on physical fitness, motor- and non-motor functioning.

Study design: Pilot double-blind randomized controlled intervention study.

Study population: A total of 30 Dutch people with PD who have no other medical conditions that markedly hamper mobility, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.

Intervention: Participants will be randomized into one of three groups. All groups will be encouraged to increase their physical activity level, measured in step counts on the participants' own smartphone, with a different percentage: (a) an increase in step count of 10% (active control group, N = 10), (b) in increase in step count of 50% (experimental group 1, N = 10), or (c) an increase in step count of 100% (experimental group 2, N = 10), compared to their baseline level.

Being tested
Step count increase with the use of a motivational application
Keywords
Physical activity, Walking, Exercise, Parkinson Disease, Locomotion, Motivational application
Medical subject headings
Movement Disorders, Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Step count increase with the use of a motivational applicationBehavioural

    The motivational app will encourage people to increase their physical activity for a short period of time (one month). Different treatment arms will receive different physical activity goals. People will get feedback and be motivated based on their own baseline level and actual activity level.

Study groups in NCT06692387
Study groupRoleWhat they receive
Active control groupActive comparatorTen people will be encouraged to increase their physical activity level, measured in step counts on the patients' own smartphone, with 10% compared to their own baseline level.
Receives: Behavioral: Step count increase with the use of a motivational application
Step count increase 50%ExperimentalTen people will be encouraged to increase their physical activity level, measured in step counts on the patients' own smartphone, with 50% compared to their own baseline level.
Receives: Behavioral: Step count increase with the use of a motivational application
Step count increase 100%ExperimentalTen people will be encouraged to increase their physical activity level, measured in step counts on the patients' own smartphone, with 100% compared to their own baseline level.
Receives: Behavioral: Step count increase with the use of a motivational application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to the last week of the intervention in step count

    Step counts measured continuously with patients' own smartphone

    Measured: Change from baseline to the last week of the intervention (week 4)

Secondary outcomes (16)

  1. Change in PD motor symptoms

    Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 3. Range: 0-132. Higher scores indicate worse function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  2. Change in Motor functioning in daily life

    Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 2. Range: 0-52. Higher scores indicate worse function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  3. Change in Physical fitness

    Meters walked during the six minute walk test (6MWT). Higher scores indicate better function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  4. Change in Mobility

    Timed Up and Go Test, number of seconds to complete standing up from a chair, walk 3 meters, turn, walk 3 meters back and sit down. Higher scores indicate worse function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  5. Change in Balance

    The mini balance evaluation system (mini-BEST) is a 14-item, 3 points ordinal rating scale (0-2 points) to evaluate balance performance in 4 subcategories: anticipatory postural control, reactive postural control, sensory orientation and stability in gait. The attainable scores ranges from 0-28 points, in which a higher score indicates better balance.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  6. Change in Gait speed

    The ten meter walk test (10MWT) is a standardised and recommended measurement of walking velocity. The number of seconds it takes to walk ten meters is recorded. Higher scores means worse function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  7. Change in Fear of falling

    Falls Efficacy Scale International [FES-I]. Range: 16-64. Higher score reflects higher fear of falling

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  8. Change in Handgrip strength

    Handgrip strength measured with a dynamometer. Higher scores mean better function.

    Measured: Change from baseline to post-intervention in the first week after week 4 (week 5)

  9. Change from baseline to post-intervention after week 4 in Self-reported physical activity level

    LASA Physical Activity Questionnaire (LAPAQ). Range: 0-no maximum. Higher score reflecting more time spent in physical activities;

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  10. Change from baseline to post-intervention after week 4 in Global PD non-motor symptoms

    Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 1. Range: 0-52. Higher scores mean worse function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  11. Change in Cognition

    Montreal Cognitive Assessment (MoCA). Range: 0-30. Higher scores reflect better cognition.

    Measured: Change from baseline to post-intervention in the first week after week 4 (week 5)

  12. Change in Depression and anxiety

    Hamilton Anxiety and Depression Scale; HADS; Minimum score = 0 (no anxiety or depression), maximum score = 42 (most anxiety or depression). Higher scores mean more anxiety/depression.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  13. Change in Apathy

    Abbreviated version of the Apathy Evaluaton Scale; AES-12PD. Range 12-48. Higher scores indicate better function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  14. Change in Sleep

    Scales for Outcomes in Parkinson's Disease-Sleep; SCOPA-SLEEP. Range: 0-33. Higher scores reflect worse sleep.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  15. Change in Autonomic dysfunction

    Scales for Outcomes in Parkinson's Disease-Autonomic questionnaire; SCOPA-AUT. Range: 0-69. Higher scores indicate more problems with autonomic function.

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

  16. Change in Health-related quality of life

    Parkinson's Disease Questionnaire; PDQ-39. Range: 0-100. Lower scores reflecting a better health-related quality of life

    Measured: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start2 Nov 2020
  3. Primary completion1 Apr 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692387
Sponsor's protocol ID
NL74352.091.20
Acronym
STEPWISE
Status last verified
Nov 2024
First submitted
3 Jul 2020
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schootemeijer S, de Vries NM, Darweesh SKL, Ascherio A, Schwarzschild MA, Macklin EA, Bloem BR. Promoting Physical Activity in People With Parkinson's Disease Through a Smartphone App: A Pilot Study. J Neurol Phys Ther. 2025 Apr 1;49(2):74-81. doi: 10.1097/NPT.0000000000000507. Epub 2025 Mar 21.

    PubMed 39763021

Questions about this trial

What is this clinical trial studying?

A study testing Step count increase with the use of a motivational application in people with Movement Disorders and Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to the last week of the intervention in step count (time frame: Change from baseline to the last week of the intervention (week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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