Parkinson DiseaseNCT03869879
Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation
A study testing Feedback-assisted physical therapy and Traditional physical therapy in people with Parkinson Disease and Stroke, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Phase II of this study includes a pragmatic clinical trial which will take place at Northwest Rehabilitation Associates (NWRA) in Salem, OR to verify the efficacy of the system in a physical therapy clinic. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Parkinson Disease, Stroke, Multiple Sclerosis
- What is being tested?
- Feedback-assisted physical therapy and Traditional physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 30 May 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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60-89 years old
- gait disturbances requiring physical therapy
Who cannot join
- unable to follow instructions (up to the practitioner's judgement)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northwest Rehabilitation Associate
Salem, Oregon, 97302
Mike Studer
About this study
Official title: Mobility Rehab: A Feedback System for Mobility Rehabilitation for Older Adults
Phase II of this study includes a pragmatic clinical trial which will take place at Northwest Rehabilitation Associates (NWRA) in Salem, OR to verify the efficacy of the system in a physical therapy clinic.
Read the detailed description
This Phase II project is a collaboration among: 1) APDM, an innovative small business that has successfully commercialized several innovative products to quantify human movement; 2) the Balance Disorders Laboratory in the department of Neurology at Oregon Health \& Science University (OHSU); and 3) NorthWest Rehabilitation Associates (NWRA), a nationally-recognized outpatient rehabilitation center that will test the effectiveness of Mobility Rehab for adults with mobility disturbances.
The objective of this Phase II application is to prepare the Mobility Rehab system for commercialization and demonstrate its efficacy for mobility training. Our hypothesis is that feedback-based rehabilitation will be more effective than standard rehabilitation for gait in older adults with gait disturbances. In this Phase II, we will use a pragmatic clinical trial to evaluate the effectiveness of Mobility Rehab on 300 patients with various types of gait disturbances in a physical therapy clinic. In addition to visual feedback, the system will be optimized in Phase II to also provide verbal feedback commands for patients during training.
- Conditions
- Parkinson Disease, Stroke, Multiple Sclerosis, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor, Gait, Unsteady
- Being tested
- Feedback-assisted physical therapy, Traditional physical therapy
- Keywords
- gait, balance, falls, mobility, feedback
- Medical subject headings
- Parkinson Disease, Stroke, Multiple Sclerosis, Gait Disorders, Neurologic, Gait Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback-assisted physical therapyOther
The system uses unobtrusive, wearable, inertial sensors with real-time algorithms to provide real-time feedback on: step time asymmetry, foot clearance, arm swing, trunk lateral range, and foot strike angle during gait.
Traditional physical therapyOther
Therapists will treat these patients with traditional therapeutic modalities and practices.
| Study group | Role | What they receive |
|---|---|---|
| Feedback-assisted physical therapy | Active comparator | During a visual feedback session, therapists will spend 30min per session using the Mobility Rehab system for gait training with patients. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks. Receives: Other: Feedback-assisted physical therapy |
| Traditional physical therapy | Placebo comparator | During a regular session, patients with gait impairment will work on gait with the following tasks for 30min: weights on ankles, dual tasks, UE support, partial body weight support, speed challenges, obstacles, and head turning. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks. Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities-Specific Balance Confidence (ABC) Scale
This questionnaire measures an individual's perception of their own balance. Individuals use a scale ranging from 0% to 100% in rating the amount of confidence they have in their balance during 16 hypothetical daily-life activities. A score of 100% would represent one being fully confident in their balance during a specific task, while a score of 0% would represent one having no confidence at all in their balance. Total score ranges from 0 to 1600.
Measured: Collected at a participant's baseline visit and final study visit, after an average of one month
Secondary outcomes (1)
Gait speed
Gait speed is measured through two instrumented, two-minute walks. The first walk is performed at the individual's casual walking pace and the second is performed at a pace the individual considers to be faster than their casual pace.
Measured: Collected at a participant's baseline visit and final study visit, after an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start24 Jul 2019
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Eligible participants are randomized into two groups. One group will receive standard physical therapy for their gait or balance issue while the other will receive visual feedback-aided physical therapy.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- NorthWest Rehabilitations Associates, APDM
- Responsible party
- Principal investigator, Martina Mancini, Oregon Health and Science University
- Investigators
- Martina Mancini, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869879
- Sponsor's protocol ID
- eIRB 16282
- Status last verified
- May 2020
- First submitted
- 20 Feb 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study raw data of motor tasks will be available, within the bounds allowed by HIPAA and institutional privacy policies.
Publications
Silva-Batista C, Harker G, Vitorio R, Studer M, Whetten B, Lapidus J, Carlson-Kuhta P, Pearson S, VanDerwalker J, Horak FB, El-Gohary M, Mancini M. Mobility Rehab visual feedback system for gait rehabilitation in older adults. J Neuroeng Rehabil. 2023 Oct 24;20(1):144. doi: 10.1186/s12984-023-01260-2.
PubMed 37875971Vitorio R, El-Gohary M, Pearson S, Carlson-Kuhta P, Harker G, Horak FB, Lapidus J, Studer M, Mancini M. Effectiveness of the Mobility Rehab System for Mobility Training in Older Adults: A Pragmatic Clinical Trial. Front Neurol. 2021 Sep 6;12:680637. doi: 10.3389/fneur.2021.680637. eCollection 2021.
PubMed 34552549
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility Rehab: A Feedback System for Mobility Rehabilitation for Older Adults
- ClinicalTrials.gov ID
- NCT03869879
- Acronym / sponsor ID
- eIRB 16282
- Conditions
- Parkinson Disease, Stroke, Multiple Sclerosis, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor, Gait, Unsteady
- Keywords
- gait, balance, falls, mobility, feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- NorthWest Rehabilitations Associates, APDM
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 11 Mar 2019 (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.
Phase II of this study includes a pragmatic clinical trial which will take place at Northwest Rehabilitation Associates (NWRA) in Salem, OR to verify the efficacy of the system in a physical therapy clinic.
Detailed description
This Phase II project is a collaboration among: 1) APDM, an innovative small business that has successfully commercialized several innovative products to quantify human movement; 2) the Balance Disorders Laboratory in the department of Neurology at Oregon Health \& Science University (OHSU); and 3) NorthWest Rehabilitation Associates (NWRA), a nationally-recognized outpatient rehabilitation center that will test the effectiveness of Mobility Rehab for adults with mobility disturbances.
The objective of this Phase II application is to prepare the Mobility Rehab system for commercialization and demonstrate its efficacy for mobility training. Our hypothesis is that feedback-based rehabilitation will be more effective than standard rehabilitation for gait in older adults with gait disturbances. In this Phase II, we will use a pragmatic clinical trial to evaluate the effectiveness of Mobility Rehab on 300 patients with various types of gait disturbances in a physical therapy clinic. In addition to visual feedback, the system will be optimized in Phase II to also provide verbal feedback commands for patients during training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants are randomized into two groups. One group will receive standard physical therapy for their gait or balance issue while the other will receive visual feedback-aided physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Feedback-assisted physical therapy | Active comparator | Other: Feedback-assisted physical therapyDuring a visual feedback session, therapists will spend 30min per session using the Mobility Rehab system for gait training with patients. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks. |
| Traditional physical therapy | Placebo comparator | Other: Traditional physical therapyDuring a regular session, patients with gait impairment will work on gait with the following tasks for 30min: weights on ankles, dual tasks, UE support, partial body weight support, speed challenges, obstacles, and head turning. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60-89 years old
- gait disturbances requiring physical therapy
Key exclusion criteria (1 listed)
- unable to follow instructions (up to the practitioner's judgement)
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 |
|---|---|---|
| Feedback-assisted physical therapyThe system uses unobtrusive, wearable, inertial sensors with real-time algorithms to provide real-time feedback on: step time asymmetry, foot clearance, arm swing, trunk lateral range, and foot strike angle during gait. | Other | Feedback-assisted physical therapy |
| Traditional physical therapyTherapists will treat these patients with traditional therapeutic modalities and practices. | Other | Traditional physical therapy |
Primary outcome
Activities-Specific Balance Confidence (ABC) Scale
Time frame: Collected at a participant's baseline visit and final study visit, after an average of one month
This questionnaire measures an individual's perception of their own balance. Individuals use a scale ranging from 0% to 100% in rating the amount of confidence they have in their balance during 16 hypothetical daily-life activities. A score of 100% would represent one being fully confident in their balance during a specific task, while a score of 0% would represent one having no confidence at all in their balance. Total score ranges from 0 to 1600.
1 secondary outcome
Gait speed
Time frame: Collected at a participant's baseline visit and final study visit, after an average of one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Derived from this study: PubMed 37875971Silva-Batista C, Harker G, Vitorio R, Studer M, Whetten B, Lapidus J, Carlson-Kuhta P, Pearson S, VanDerwalker J, Horak FB, El-Gohary M, Mancini M. Mobility Rehab visual feedback system for gait rehabilitation in older adults. J Neuroeng Rehabil. 2023 Oct 24;20(1):144. doi: 10.1186/s12984-023-01260-2.
- Derived from this study: PubMed 34552549Vitorio R, El-Gohary M, Pearson S, Carlson-Kuhta P, Harker G, Horak FB, Lapidus J, Studer M, Mancini M. Effectiveness of the Mobility Rehab System for Mobility Training in Older Adults: A Pragmatic Clinical Trial. Front Neurol. 2021 Sep 6;12:680637. doi: 10.3389/fneur.2021.680637. eCollection 2021.
- Individual participant dataSharing planned: Yes. At the conclusion of the study raw data of motor tasks will be available, within the bounds allowed by HIPAA and institutional privacy policies.
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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.
Martina Mancini, PhD principal investigator
Oregon Health and Science 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 Feedback-assisted physical therapy and Traditional physical therapy in people with Parkinson Disease and Stroke, run by Oregon Health and Science 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 1 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 11 May 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. Some participants in this study may receive a placebo. 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?
Contact Martina Mancini, PhD (503-418-2602, mancinim@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities-Specific Balance Confidence (ABC) Scale (time frame: Collected at a participant's baseline visit and final study visit, after an average of one month). 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 NCT03869879, which also lists 2 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 11 May 2020.