Parkinson DiseaseEarly Phase 1(MEP+G)NCT06538298
Title: A Multimodal Exercise Program With Gamification for Parkinson Disease (MEP+G)
A Early Phase 1 study testing Multimodal Exercise Program with Gamification in people with Parkinson Disease, run by California State University, Northridge at 1 site in United States.
Trial summary
In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study. This 8 week pilot study will utilize a comprehensive exercise program that includes non-contact boxing along with computerized games for individuals with Parkinson… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Multimodal Exercise Program with Gamification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2024to 27 Jun 2026
- Phase
- Early Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn and Yahr stages 1-3 disease as determined by primary care physician, neurologist, or movement disorder specialist
- diagnosis of idiopathic Parkinson's Disease
- ability to ambulate with or without an assistive device
- transportation to and from testing site
- ability to stand unassisted for 10 minutes
- stable on Parkinson's disease medications for 3 months as determined by physician
- medical clearance by their PCP, neurologist, or movement disorder specialist to participate in a moderate to vigorous exercise program.
Who cannot join
- other neurological disease other than Parkinson's disease
- having had deep brain stimulation within the past 3 months , as determined by their physician
- currently participating in a Rock Steady boxing program
- self-report participation in moderate to vigorous exercise greater than 60 minutes per week.
- required
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Equilibrium Physical Therapy
Ventura, California, 93003
Amy Griffin, DPT, 805-339-9718, agriffin@equilibrium-bpc.com
About this study
Official title: A Multimodal Exercise Program With Gamification (MEP+G) in Individuals With Parkinson Disease: a Pilot Randomized Controlled Trial
In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study. This 8 week pilot study will utilize a comprehensive exercise program that includes non-contact boxing along with computerized games for individuals with Parkinson Disease.
Read the detailed description
Participates in the 6-week exercise group will be asked to perform the following three times per week for 6 weeks, with each session lasting 60 minutes: A multimodal group exercise program with approximately 3-5 other individuals with Parkinson's disease. The exercise program will consist of strengthening, balance, aerobic, flexibility, and the use of a computerized game to challenge participant's thinking and reactions skills. The exercise program will also consist of non-contact boxing (hitting punching bags) to improve strength, balance, and aerobic endurance. Each exercise session will be conducted by a licensed physical therapist who is trained in exercise programs using non-contact boxing (Certified Rock Steady Boxing Coach). Each exercise session will have the same format and exercises with only a slight variation. For example, all Monday classes will have a focus on strengthening, Wednesday classes will have a focus on balance and Friday classes will have a focus on power.
The format will consist of a 10-15-minute warm-up of stretching and exercises to gradually warm-up participant's muscles and increase heart rate. Following the warm-up, participates will complete 30 minutes of moderate to vigorous circuit training using boxing drills and a computerized game called SMARTfit. SMARTfit consists of a standing computer board that allows participants to touch, punch or kick it while playing a game i.e., hitting all the buttons that display a smiley face.
At the end of the 30 minutes, participants will complete a 10-15-minute cool-down consisting of core strengthening, posture training, and hip strengthening and stretching exercises. Participants will also be instructed to maintain their normal activities outside of the study intervention.
In the event participants missed any of the exercise sessions, a one-week "make up week" will be provided immediately following the 6-week intervention that participants can choose to attend.
Exercise Intensity will be monitored using a heart rate chest monitor (Myzone™). The Myzone™) heart rate monitor will allow the instructor/researcher to monitor heart rate during the exercise session via a computer screen and to evaluate exercise response after the session is completed to determine whether to increase or decrease the intensity. For the first two weeks, participants will be instructed to stay in the "moderate" range of intensity during the 30 minutes of circuit training. The following four weeks participants will be instructed to increase their effort to vigorous as assessed and determined by the instructor. Moderate intensity is defined as 70-80 percent of estimated maximum heart rate. Vigorous intensity is defined as 80-90 percent estimated maximum heart rate.
Estimated maximum heart rate is determined by: 208-.7 X age. Estimated maximum heart rate will be adjusted for participants on beta blockers or other blood pressure lowering medications (164-.7 X age).
At the end of each exercise session the instructor will complete the data sheet on the daily scripted exercise plan. For example, the instructor will document whether the participant was present, had any adverse events, able to complete the exercises as prescribed etc.
Wait List Control Group Participants randomly assigned to the wait list control group, will perform baseline testing and be instructed not to change their exercise habits. After 6 weeks participants will complete post-testing (described below) and be offered to be enrolled in the 6-week exercise group as described above. If participants decide to participate in the exercise group and still meet the inclusion and exclusion criteria, they will perform baseline testing, 6 weeks of exercise followed by another post-testing.
Week #10 (Post Testing): Participants will complete the same surveys and clinical measures as performed during for pre-testing. Post-testing will be approximately 60 minutes. Participants will also be provided qualitative and quantitative questions via an anonymous link and/or QR code to a Qualtrics survey pertaining to their experience and satisfaction with the program.
Quantitative questions will use a rating scale of 1-5 with 1= strongly agree; 2= somewhat agree; 3= neutral; 4; somewhat disagree; 5; strongly disagree. Questions will pertain to usefulness of the program, ease of use, burden of doing the exercises/testing, comprehensibility.
Qualitative questions will be open ended asking about most/least helpful components, met expectations, suggestions for improvement, perceived safety of doing the exercises and testing and intent to continue the exercise program.
- Conditions
- Parkinson Disease
- Being tested
- Multimodal Exercise Program with Gamification
- Keywords
- Multimodal Exercise, Gamification, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Exercise Program with GamificationOther
A comprehensive exercise program for 3 days a week for 6 weeks that utilizes non-contact boxing and gamification at moderate to vigorous intensity.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Exercise Program with Gamification | Experimental | The exercise program will be for 6 weeks, 3 days per week for 60 minutes per session and will consist of strengthening, balance, aerobic, flexibility, and use a computerized game to challenge thinking and reactions skills. The exercise program will also consist of non-contact boxing to improve strength, balance, and aerobic endurance.
Each exercise session will be conducted by a licensed physical therapist. The format will consist of a 10-15-minute warm-up followed by 30 minutes of moderate to vigorous circuit training using boxing drills and a computerized game called SMARTfit. SMARTfit consists of a standing computer board that allows participants to touch, punch or kick it while playing a game. At the end of the 30 minutes, participants will complete a 10-15-minute cool-down consisting of core strengthening, posture training, and hip strengthening and stretching exercises. Participants will also be instructed to maintain their normal activities outside of the study intervention. Receives: Other: Multimodal Exercise Program with Gamification |
| Wait List Control | No intervention | Participants randomly assigned to the wait list control group, will perform baseline testing and be instructed not to change their exercise habits. After 6 weeks participants will complete post-testing (described below) and be offered to be enrolled in the 6-week exercise group as described above. If participants decide to participate in the exercise group and still meet the inclusion and exclusion criteria, they will perform baseline testing, 6 weeks of exercise followed by another post-testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity of intervention
Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no".
Measured: 21 months
Intervention Adherence
Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no"
Measured: 21 months
Feasibility of Outcomes
Retention: number of participants who completed the entire program divided by total number who started; x 100 to determine the percentage of participants who completed the program.
Measured: 21 months
Assessment of Data Collection
Data collection: measured using a pre-populated form and marked as a "yes" or "no" by the PI.
Measured: 21 months
Assessment of Safety
Adverse events (i.e., falls): measured by the daily exercise plan as indicated by a numeric number and type of adverse event
Measured: 21 months
Assessment of Participants Perception
Measured via Qualtrics survey asking participants "How satisfied were you in participating in this study" using an ordinal scale (0-4): (4)(strongly agree; (3)agree; (2)neutral; (1)disagree; (0)strongly disagree); with a higher score reflection increased satisfaction
Measured: 21 months
Secondary outcomes (8)
Balance
Measured via using the Mini Balance Evaluation System Test (Mini-BESTest): a series of subtests with a total score from 0-28 points; with a higher score indicating improved balance.
Measured: 21 months
Gait
Measured via Functional Gait Assessment (FGA): series of subtests based out of score from 0- 30 points; with a higher score indicating improved postural stability while walking.
Measured: 21 months
Physical Activity
Measured via International Physical Activity Questionnaire (IPAQ) based on minutes exercise per week with a higher number of minutes indicating increased physical activity
Measured: 21 months
Gait Speed
Gait speed measured via 10 meters divided by number of seconds to determine gait speed of meters per second (m/s); a increased in m/s indicating improved gait speed.
Measured: 21 months
Functional Strength
Functional strength measured by number of seconds required to perform 5 sit to stands (5TSTS) with a decrease in time indicating improved functional strength.
Measured: 21 months
Cardiovascular Endurance
Cardiovascular endurance measured by total number of feet walked within a 6 minute timeframe (6MWT); an increase number of steps indicating improved cardiovascular endurance.
Measured: 21 Months
Quality of life of Participants
Quality of life measured by Parkinson Disease Questionnaire: 39 (PDQ39) questions asking participants to rate various aspects of their condition using an ordinal scale: 0-4 (4)(Always, (3)Often, (2)Occasionally, (1)Sometimes, (0)Never; with a higher score indicating an increased quality of life
Measured: 21 months
Disease Severity
Disease severity measured by the Movement Disorder Society Unified Parkinson DiseaseRating (MDS UPDRS); 18 items measured using an ordinal scale (0-4).0=none;1=slight;2=minimal;3; moderate;4=severe; with a lower score indicating less severity
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion26 May 2026 (estimated)
- Study completion27 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized Controlled Pilot Study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, Northridge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S Bartlett, PhD, Principal investigator, California State University, Northridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538298
- Sponsor's protocol ID
- IRB-FY24-23
- Acronym
- (MEP+G)
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
PubMed 29228079Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790El-Kotob R, Giangregorio LM. Pilot and feasibility studies in exercise, physical activity, or rehabilitation research. Pilot Feasibility Stud. 2018 Aug 14;4:137. doi: 10.1186/s40814-018-0326-0. eCollection 2018.
PubMed 30123527Landers MR, Ellis TD. A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy. JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e18985. doi: 10.2196/18985.
PubMed 33016887Sangarapillai K, Norman BM, Almeida QJ. Boxing vs Sensory Exercise for Parkinson's Disease: A Double-Blinded Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):769-777. doi: 10.1177/15459683211023197. Epub 2021 Jun 13.
PubMed 34121511Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.
PubMed 34963139Langbroek-Amersfoort A, Schootemeijer S, Bouten L, Bloem BR, De Vries NM. Exercise Made Accessible: the Merits of Community-Based Programs for Persons with Parkinson's Disease. Curr Neurol Neurosci Rep. 2023 Nov;23(11):695-715. doi: 10.1007/s11910-023-01303-0. Epub 2023 Oct 4.
PubMed 37792207
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Exercise Program With Gamification (MEP+G) in Individuals With Parkinson Disease: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06538298
- Acronym / sponsor ID
- (MEP+G) / IRB-FY24-23
- Conditions
- Parkinson Disease
- Keywords
- Multimodal Exercise, Gamification, Parkinson's Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- California State University, NorthridgeUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 26 May 2026 (estimated)
- Study completion
- 27 Jun 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study. This 8 week pilot study will utilize a comprehensive exercise program that includes non-contact boxing along with computerized games for individuals with Parkinson Disease.
Detailed description
Participates in the 6-week exercise group will be asked to perform the following three times per week for 6 weeks, with each session lasting 60 minutes: A multimodal group exercise program with approximately 3-5 other individuals with Parkinson's disease. The exercise program will consist of strengthening, balance, aerobic, flexibility, and the use of a computerized game to challenge participant's thinking and reactions skills. The exercise program will also consist of non-contact boxing (hitting punching bags) to improve strength, balance, and aerobic endurance. Each exercise session will be conducted by a licensed physical therapist who is trained in exercise programs using non-contact boxing (Certified Rock Steady Boxing Coach). Each exercise session will have the same format and exercises with only a slight variation. For example, all Monday classes will have a focus on strengthening, Wednesday classes will have a focus on balance and Friday classes will have a focus on power.
The format will consist of a 10-15-minute warm-up of stretching and exercises to gradually warm-up participant's muscles and increase heart rate. Following the warm-up, participates will complete 30 minutes of moderate to vigorous circuit training using boxing drills and a computerized game called SMARTfit. SMARTfit consists of a standing computer board that allows participants to touch, punch or kick it while playing a game i.e., hitting all the buttons that display a smiley face.
At the end of the 30 minutes, participants will complete a 10-15-minute cool-down consisting of core strengthening, posture training, and hip strengthening and stretching exercises. Participants will also be instructed to maintain their normal activities outside of the study intervention.
In the event participants missed any of the exercise sessions, a one-week "make up week" will be provided immediately following the 6-week intervention that participants can choose to attend.
Exercise Intensity will be monitored using a heart rate chest monitor (Myzone™). The Myzone™) heart rate monitor will allow the instructor/researcher to monitor heart rate during the exercise session via a computer screen and to evaluate exercise response after the session is completed to determine whether to increase or decrease the intensity. For the first two weeks, participants will be instructed to stay in the "moderate" range of intensity during the 30 minutes of circuit training. The following four weeks participants will be instructed to increase their effort to vigorous as assessed and determined by the instructor. Moderate intensity is defined as 70-80 percent of estimated maximum heart rate. Vigorous intensity is defined as 80-90 percent estimated maximum heart rate.
Estimated maximum heart rate is determined by: 208-.7 X age. Estimated maximum heart rate will be adjusted for participants on beta blockers or other blood pressure lowering medications (164-.7 X age).
At the end of each exercise session the instructor will complete the data sheet on the daily scripted exercise plan. For example, the instructor will document whether the participant was present, had any adverse events, able to complete the exercises as prescribed etc.
Wait List Control Group Participants randomly assigned to the wait list control group, will perform baseline testing and be instructed not to change their exercise habits. After 6 weeks participants will complete post-testing (described below) and be offered to be enrolled in the 6-week exercise group as described above. If participants decide to participate in the exercise group and still meet the inclusion and exclusion criteria, they will perform baseline testing, 6 weeks of exercise followed by another post-testing.
Week #10 (Post Testing): Participants will complete the same surveys and clinical measures as performed during for pre-testing. Post-testing will be approximately 60 minutes. Participants will also be provided qualitative and quantitative questions via an anonymous link and/or QR code to a Qualtrics survey pertaining to their experience and satisfaction with the program.
Quantitative questions will use a rating scale of 1-5 with 1= strongly agree; 2= somewhat agree; 3= neutral; 4; somewhat disagree; 5; strongly disagree. Questions will pertain to usefulness of the program, ease of use, burden of doing the exercises/testing, comprehensibility.
Qualitative questions will be open ended asking about most/least helpful components, met expectations, suggestions for improvement, perceived safety of doing the exercises and testing and intent to continue the exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Multimodal Exercise Program with Gamification | Experimental | Other: Multimodal Exercise Program with GamificationThe exercise program will be for 6 weeks, 3 days per week for 60 minutes per session and will consist of strengthening, balance, aerobic, flexibility, and use a computerized game to challenge thinking and reactions skills. The exercise program will also consist of non-contact boxing to improve strength, balance, and aerobic endurance. Each exercise session will be conducted by a licensed physical therapist. The format will consist of a 10-15-minute warm-up followed by 30 minutes of moderate to vigorous circuit training using boxing drills and a computerized game called SMARTfit. SMARTfit consists of a standing computer board that allows participants to touch, punch or kick it while playing a game. At the end of the 30 minutes, participants will complete a 10-15-minute cool-down consisting of core strengthening, posture training, and hip strengthening and stretching exercises. Participants will also be instructed to maintain their normal activities outside of the study intervention. |
| Wait List Control | No intervention | –Participants randomly assigned to the wait list control group, will perform baseline testing and be instructed not to change their exercise habits. After 6 weeks participants will complete post-testing (described below) and be offered to be enrolled in the 6-week exercise group as described above. If participants decide to participate in the exercise group and still meet the inclusion and exclusion criteria, they will perform baseline testing, 6 weeks of exercise followed by another post-testing. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hoehn and Yahr stages 1-3 disease as determined by primary care physician, neurologist, or movement disorder specialist
- diagnosis of idiopathic Parkinson's Disease
- ability to ambulate with or without an assistive device
- transportation to and from testing site
- ability to stand unassisted for 10 minutes
Key exclusion criteria (5 listed)
- other neurological disease other than Parkinson's disease
- having had deep brain stimulation within the past 3 months , as determined by their physician
- currently participating in a Rock Steady boxing program
- self-report participation in moderate to vigorous exercise greater than 60 minutes per week.
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 |
|---|---|---|
| Multimodal Exercise Program with GamificationA comprehensive exercise program for 3 days a week for 6 weeks that utilizes non-contact boxing and gamification at moderate to vigorous intensity. | Other | Multimodal Exercise Program with Gamification |
Primary outcome
Fidelity of intervention
Time frame: 21 months
Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no".
Intervention Adherence
Time frame: 21 months
Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no"
Feasibility of Outcomes
Time frame: 21 months
Retention: number of participants who completed the entire program divided by total number who started; x 100 to determine the percentage of participants who completed the program.
Assessment of Data Collection
Time frame: 21 months
Data collection: measured using a pre-populated form and marked as a "yes" or "no" by the PI.
Assessment of Safety
Time frame: 21 months
Adverse events (i.e., falls): measured by the daily exercise plan as indicated by a numeric number and type of adverse event
Assessment of Participants Perception
Time frame: 21 months
Measured via Qualtrics survey asking participants "How satisfied were you in participating in this study" using an ordinal scale (0-4): (4)(strongly agree; (3)agree; (2)neutral; (1)disagree; (0)strongly disagree); with a higher score reflection increased satisfaction
8 secondary outcomes
Balance
Time frame: 21 months
Gait
Time frame: 21 months
Physical Activity
Time frame: 21 months
Gait Speed
Time frame: 21 months
Functional Strength
Time frame: 21 months
Cardiovascular Endurance
Time frame: 21 Months
Quality of life of Participants
Time frame: 21 months
Disease Severity
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 29228079Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
- Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Background: PubMed 30123527El-Kotob R, Giangregorio LM. Pilot and feasibility studies in exercise, physical activity, or rehabilitation research. Pilot Feasibility Stud. 2018 Aug 14;4:137. doi: 10.1186/s40814-018-0326-0. eCollection 2018.
- Background: PubMed 33016887Landers MR, Ellis TD. A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy. JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e18985. doi: 10.2196/18985.
- Background: PubMed 34121511Sangarapillai K, Norman BM, Almeida QJ. Boxing vs Sensory Exercise for Parkinson's Disease: A Double-Blinded Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):769-777. doi: 10.1177/15459683211023197. Epub 2021 Jun 13.
- Background: PubMed 34963139Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.
- Background: PubMed 37792207Langbroek-Amersfoort A, Schootemeijer S, Bouten L, Bloem BR, De Vries NM. Exercise Made Accessible: the Merits of Community-Based Programs for Persons with Parkinson's Disease. Curr Neurol Neurosci Rep. 2023 Nov;23(11):695-715. doi: 10.1007/s11910-023-01303-0. Epub 2023 Oct 4.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Andrew S Bartlett, PhD principal investigator
California State University, Northridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Multimodal Exercise Program with Gamification in people with Parkinson Disease, run by California State University, Northridge 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 7 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: status not confirmed, as of the sponsor's last update on 7 Aug 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Andrew S Bartlett, PhD (5857646717, Andrew.Bartlett@csun.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity of intervention (time frame: 21 months). The study lists 6 primary outcomes in all. 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 NCT06538298, which also lists 7 linked publications.
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 7 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.