Parkinson DiseaseNCT04223245
A Home Program Using Multimodal Sensory Feedback for People With Parkinson Disease
A study testing exercise+multi-modal sensory feedback (MMSF) and Exercise only in people with Parkinson Disease, run by Regis University at 1 site in United States.
Trial summary
People with Parkinson Disease (PWPD) have significant problems with velocity, safety and dual tasking during walking that may be secondary to poor automaticity. Sensory functions, especially visual dependence and proprioceptive integration are critical for efficient walking and are often impaired. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- exercise+multi-modal sensory feedback (MMSF) and Exercise only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2017to 8 Mar 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of Parkinson Disease
- A score of 26 or higher on the Mini-Mental Status Exam
- Able to stand from sitting and take 5 steps without assistance
- People who have been on the same dosages of medication for PD for 3 weeks or longer
Who cannot join
- Participating in an exercise program for less than 3 months
- Plans to change a current exercise program during the study
- Changes in medications that affect PD or its sequelea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.
People with Parkinson Disease (PWPD) have significant problems with velocity, safety and dual tasking during walking that may be secondary to poor automaticity. Sensory functions, especially visual dependence and proprioceptive integration are critical for efficient walking and are often impaired. This home program compares the use of multimodal sensory feedback during stepping and balance exercises in PWPD to a group without the sensory feedback performing the same basic exercises.
Read the detailed description
Parkinson disease impairs motor and sensory functions. Automaticity of gait is lost increasing the use of higher center control of walking, leading to cognitive fatigue, slower movement and motor errors. People with Parkinson disease (PWPD) improve motor performance when external sensory cues, which bypass the faulty basal ganglia, are used during interventions. Enhancing proprioceptive, visual and vestibular cues that are critical for walking has the potential to improve gait and decrease cognitive fatigue by restoring automaticity.
This is a single-blinded randomized controlled study with repeated measures to evaluate the effects of a home exercise program with or without the addition of multi-modal sensory feedback (MMSF) in real-time on automaticity of gait and balance. PWPDs are randomly assigned to one of 2 home exercise groups. There are two 6 week exercise sessions with a 6 week of no exercises inter-spaced between them. The exercises promote rapid and large movement in stepping activities, balance using self-perturbation through single, leg swings and standing on a compliant surface for sensory re-weighting. People in the experimental group perform the program with real-time with MMSF. Participants are to progress exercises in speed and distance as well as performing with eyes closed to improve proprioceptive processing and automaticity.
- Conditions
- Parkinson Disease
- Being tested
- exercise+multi-modal sensory feedback (MMSF), Exercise only
- Keywords
- multimodal, real-time feedback, automaticity, gait, balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise+multi-modal sensory feedback (MMSF)Behavioural
home program of 3 stepping exercises and 3 balance exercises with progression of speed, step distance and reduced vision. Real-time sensory feedback during ex. using ankle, wrist wts., laser on chest and mat with footpads and clickers (auditory feedback during stepping)
Exercise onlyBehavioural
3 stepping and 3 balance exercises which are to progress in speed and distance of movement as well as progress to eyes closed while performing.
| Study group | Role | What they receive |
|---|---|---|
| exercise+MMSF | Experimental | Group of PWPD who performed a base exercise program of speed and large amplitude stepping and standing balance exercises with Multimodal real-time sensory feedback Receives: Behavioral: exercise+multi-modal sensory feedback (MMSF) |
| exercise only | Active comparator | Group PWPD who did the same exercise program without MMSF Receives: Behavioral: Exercise only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in temporalspatial components of Gait
temporal and spacial components of gait measured with Gaitrite Mat
Measured: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
changes in balance
single leg stance time, time standing on foam eyes closed, Mini-BESTest
Measured: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Change in cognitive attention needed for gait
3 meter walk test performed at comfortable gait speed once and repeated while subtracting 3s from 100 to assess cognitive attention needed for walking tasks (automaticity)
Measured: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Change in perceived difficulty during gait and ADLs,
Parkinson Disease Questionnaire (PDQ-39)
Measured: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start29 Jun 2017
- Primary completion17 Oct 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Single blind randomized trial with 2 groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia A Winkler, PT, DSc, Principal investigator, Regis University, 3333 Regis Blvd , Denver, Co 80221
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223245
- Sponsor's protocol ID
- 1008713-3
- Status last verified
- Jan 2020
- First submitted
- 2 Dec 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.
- ClinicalTrials.gov ID
- NCT04223245
- Acronym / sponsor ID
- 1008713-3
- Conditions
- Parkinson Disease
- Keywords
- multimodal, real-time feedback, automaticity, gait, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Regis UniversityUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with Parkinson Disease (PWPD) have significant problems with velocity, safety and dual tasking during walking that may be secondary to poor automaticity. Sensory functions, especially visual dependence and proprioceptive integration are critical for efficient walking and are often impaired. This home program compares the use of multimodal sensory feedback during stepping and balance exercises in PWPD to a group without the sensory feedback performing the same basic exercises.
Detailed description
Parkinson disease impairs motor and sensory functions. Automaticity of gait is lost increasing the use of higher center control of walking, leading to cognitive fatigue, slower movement and motor errors. People with Parkinson disease (PWPD) improve motor performance when external sensory cues, which bypass the faulty basal ganglia, are used during interventions. Enhancing proprioceptive, visual and vestibular cues that are critical for walking has the potential to improve gait and decrease cognitive fatigue by restoring automaticity.
This is a single-blinded randomized controlled study with repeated measures to evaluate the effects of a home exercise program with or without the addition of multi-modal sensory feedback (MMSF) in real-time on automaticity of gait and balance. PWPDs are randomly assigned to one of 2 home exercise groups. There are two 6 week exercise sessions with a 6 week of no exercises inter-spaced between them. The exercises promote rapid and large movement in stepping activities, balance using self-perturbation through single, leg swings and standing on a compliant surface for sensory re-weighting. People in the experimental group perform the program with real-time with MMSF. Participants are to progress exercises in speed and distance as well as performing with eyes closed to improve proprioceptive processing and automaticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind randomized trial with 2 groups
| Arm | Type | Receives |
|---|---|---|
| exercise+MMSF | Experimental | Behavioral: exercise+multi-modal sensory feedback (MMSF)Group of PWPD who performed a base exercise program of speed and large amplitude stepping and standing balance exercises with Multimodal real-time sensory feedback |
| exercise only | Active comparator | Behavioral: Exercise onlyGroup PWPD who did the same exercise program without MMSF |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medical diagnosis of Parkinson Disease
- A score of 26 or higher on the Mini-Mental Status Exam
- Able to stand from sitting and take 5 steps without assistance
- People who have been on the same dosages of medication for PD for 3 weeks or longer
Key exclusion criteria (3 listed)
- Participating in an exercise program for less than 3 months
- Plans to change a current exercise program during the study
- Changes in medications that affect PD or its sequelea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise+multi-modal sensory feedback (MMSF)home program of 3 stepping exercises and 3 balance exercises with progression of speed, step distance and reduced vision. Real-time sensory feedback during ex. using ankle, wrist wts., laser on chest and mat with footpads and clickers (auditory feedback during stepping) | Behavioural | exercise+MMSF |
| Exercise only3 stepping and 3 balance exercises which are to progress in speed and distance of movement as well as progress to eyes closed while performing. | Behavioural | exercise only |
Primary outcome
Changes in temporalspatial components of Gait
Time frame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
temporal and spacial components of gait measured with Gaitrite Mat
changes in balance
Time frame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
single leg stance time, time standing on foam eyes closed, Mini-BESTest
Change in cognitive attention needed for gait
Time frame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
3 meter walk test performed at comfortable gait speed once and repeated while subtracting 3s from 100 to assess cognitive attention needed for walking tasks (automaticity)
Change in perceived difficulty during gait and ADLs,
Time frame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Parkinson Disease Questionnaire (PDQ-39)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Winkler, PT, DSc principal investigator
Regis University, 3333 Regis Blvd , Denver, Co 80221
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise+multi-modal sensory feedback (MMSF) and Exercise only in people with Parkinson Disease, run by Regis University at 1 site in United States.
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 4 inclusion and 3 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 10 Jan 2020. 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 United States. 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?
Changes in temporalspatial components of Gait (time frame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2020.