Parkinson's DiseaseNCT01917903
Cognitive-motor Training for PD
A study testing Gait-cognitive training and Identification of at risk variables in people with Parkinson's Disease, run by Stony Brook University at 1 site in United States.
Trial summary
This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Gait-cognitive training and Identification of at risk variables
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 15 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease with our without cognitive impairment
- ambulatory for at least 200 feet without an assistive device (cane, walker, etc)
Who cannot join
- recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
- concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
- cardiac insufficiency limiting ability to participate in walking study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University RRAMP Laboratory
Stony Brook, New York, 11794-6018
About this study
Official title: The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.
This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously. By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD. Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty. Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention. The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.
Read the detailed description
In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone. Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking. During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into two training groups and asked to come to the lab three times a week for four weeks during the intervention. One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit. The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.
- Conditions
- Parkinson's Disease
- Being tested
- Gait-cognitive training, Identification of at risk variables
- Keywords
- walking, Parkinson's disease, physical therapy, falls, memory, attention, multitasking, exercise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait-cognitive trainingBehavioural
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
Identification of at risk variablesBehavioural
Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive). Spatiotemporal measures of gait will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Identification of at risk variables | Experimental | Individuals will come in for a single visit to perform all tasks / conditions. Measurements will be taken of spatial and temporal features of walking with and without a secondary task. In addition, cognitive tests of memory and attention will be performed. Outcomes will narrow measures to those most likely to show clinically significant change. Receives: Behavioral: Identification of at risk variables |
| Gait-Cognitive training | Experimental | Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking. Receives: Behavioral: Gait-cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal measures of gait across conditions and over time.
Changes in gait parameters are a key measure of the difficulty of performing two tasks at once. Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.
Measured: Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)
Secondary outcomes (1)
Changes in cognitive performance measured with serial sevens.
Participants will count backward by sevens from a digit between 90 and 100. The ability to perform the task will be used as a measure of cognitive trade-off relative to walking performance.
Measured: Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start26 Oct 2020
- Primary completion17 Dec 2021
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Muratori, Stony Brook University
- Investigators
- Lisa M Muratori, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917903
- Sponsor's protocol ID
- 64249
- Status last verified
- Jan 2022
- First submitted
- 30 Jul 2013
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT01917903
- Acronym / sponsor ID
- 64249
- Conditions
- Parkinson's Disease
- Keywords
- walking, Parkinson's disease, physical therapy, falls, memory, attention, multitasking, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 7 Aug 2013 (estimated)
- 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.
This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously. By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD. Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty. Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention. The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.
Detailed description
In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone. Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking. During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into two training groups and asked to come to the lab three times a week for four weeks during the intervention. One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit. The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Identification of at risk variables | Experimental | Behavioral: Identification of at risk variablesIndividuals will come in for a single visit to perform all tasks / conditions. Measurements will be taken of spatial and temporal features of walking with and without a secondary task. In addition, cognitive tests of memory and attention will be performed. Outcomes will narrow measures to those most likely to show clinically significant change. |
| Gait-Cognitive training | Experimental | Behavioral: Gait-cognitive trainingParticipants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson's disease with our without cognitive impairment
- ambulatory for at least 200 feet without an assistive device (cane, walker, etc)
Key exclusion criteria (3 listed)
- recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
- concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
- cardiac insufficiency limiting ability to participate in walking study
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 |
|---|---|---|
| Gait-cognitive trainingParticipants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking. | Behavioural | Gait-Cognitive training |
| Identification of at risk variablesParticipants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive). Spatiotemporal measures of gait will be collected. | Behavioural | Identification of at risk variables |
Primary outcome
Spatiotemporal measures of gait across conditions and over time.
Time frame: Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)
Changes in gait parameters are a key measure of the difficulty of performing two tasks at once. Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.
1 secondary outcome
Changes in cognitive performance measured with serial sevens.
Time frame: Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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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.
Lisa M Muratori principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait-cognitive training and Identification of at risk variables in people with Parkinson's Disease, run by Stony Brook 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 2 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: status not confirmed, as of the sponsor's last update on 18 Jan 2022. 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?
Results are not available in the source record.
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?
Spatiotemporal measures of gait across conditions and over time. (time frame: Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)). 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 18 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.