Healthy NormalsNCT01727856
Usability and Reliability of a New Physical Therapy Tool
An observational study of Healthy Normals, run by Reflexion Health, Inc. at 1 site in United States.
Trial summary
Rehabilitation exercise conducted at home following injury improves clinical and functional outcomes. Optimum compliance with prescribed exercise regimens requires regular patient instruction, performance assessment, monitoring and general encouragement from healthcare staff. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Normals
- What is being tested?
- Rehabilitation Measurement Tool
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2012
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy males and femailes, ages 18-35
Who may be able to join
- Healthy Males and Females
- Age 18-35
Who cannot join
- Active knee symptoms
- Enrollment in knee physical therapy within 3 months of evaluation
- External or implanted lower extremity prosthetics
- Administration of regularly scheduled pain medication for lower extremities including oral, topical, or intra-articular routes of delivery
- Surgery or procedures within 3 months prior to enrollment
- Previous History of traumatic Knee Injury that required surgical intervention and/or resulted in baseline knee functional disability
Show all 11Show fewer
- Pregnant women
- Significant cognitive impairment
- Neurovestibular deficits resulting in impaired balance and proprioception
- Traumatic brain injury
- Loss of function or immobilization of both upper extremities
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: An Evaluation of a Novel Motion Tracking Enabled Knee Physical Therapy Application With Healthy Patients to Assess Reliability and Usability
Rehabilitation exercise conducted at home following injury improves clinical and functional outcomes. Optimum compliance with prescribed exercise regimens requires regular patient instruction, performance assessment, monitoring and general encouragement from healthcare staff. Exercise at home though convenient for patients is not conducive for provision of the professional support needed to maximize prescribed regimen effectiveness.
Software in development by Reflexion Health Inc. along with the Naval Medical Center San Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during at-home rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware platform for the designed software package tentatively called, "Reflexion." Kinect® contains a marker-less/controller-less motion tracking camera. The final Reflexion software will rely on a "Rehabilitation Measurement Tool (RMT)" to detect cardinal plane skeletal joint movement and its velocity utilizing the embedded Kinect® camera while also providing patient visual feedback via an avatar on a television screen.
Read more
In this observational minimal risk study, RMT/Kinect® functional reliability and usability will be assessed. Twenty healthy subjects will physically set-up and turn-on the hardware/software system; receive exercise directions from the RMT; then conduct a series of knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair.
An initial limited data set, obtained by Reflexion Health, provided validity and reliability measures. Eighteen degrees of absolute difference was detected between manual goniometry and Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise. Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A correctable systematic bias toward underestimation by the RMT will allow for future more accurate estimations of joint positioning improving face validity.
RMT functional reliability and general usability will be expressed in this study utilizing descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect® camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software errors and failure will tallied and measured to ascertain RMT reliability.
User-RMT interaction quality will be evaluated with video recordings of each set-up and exercise session. Specifically, usability measures will include: need for additional assistance setting-up or operating the RMT; number of attempts required by the subject to interact with a specific feature: time spent on specific elements during the session. Participant feedback will be elicited post-session using two scaled questionnaires: System Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide software modifications needed prior to implementation of future clinical studies within the NMCSD population.
Read the detailed description
- General Approach: We plan on using an observational study design to assess the reliability and usability of the RMT by healthy volunteers as they participate in a simulated session of knee physical therapy as presented by the RMT. Each session will be supervised by research staff and recorded for later review and assessment of areas of concern for reliability and usability.
- Methods: The study will use 20 (n=20) healthy volunteers. These subjects will be actively recruited from Naval Medical Center San Diego and Orthopedic by research staff. We will also use an informational flyer placed in the NMCSD Physical Therapy and Orthopedic outpatient clinic waiting room. No medical records will be used to identify subjects for recruitment. Subjects will be approached by research staff and will be asked about participation and will undergo standard practices regarding meeting, inclusion and exclusion criteria and clinical trial consent by trained research staff. Those who consent to participate will be taken to an area that houses the RMT hardware and software. Subjects will then undergo a brief 5 minute tutorial on the setup, power-on, and navigation of the hardware and gesture controlled software. After the orientation session each subject will be presented the RMT hardware and asked to connect the hardware components via provided cables and subsequently power on the system and application as well as position themselves correctly in front of the camera. Next, they will be instructed to follow the on screen prompts to enter their subject ID and pertinent login information and navigate the system using gestures. Following the setup process they will then proceed to engage in four exercises sequentially presented by the RMT software. Approximately 5 repetitions of each exercise will be recorded and evaluated by the RMT after which the subject will be asked to follow the onscreen prompts to review a summary of their activity as presented by the RMT and exit the application. After their interaction with the RMT they will be asked to complete a System Usability Scale questionnaire as well as a Reflexion Usability Scale questionnaire. We anticipate the total time required by each subject will be approximately 45 minutes. Research staff will be available to provide any assistance as requested by the subjects in their interaction with the RMT. Additionally, staff will also intervene while consented subjects perform the exercises if they detect any signs of impending injury or harm. Subjects will be allowed to terminate their involvement at any time and for any reason. Review of the research staff notes during the subject interaction with the RMT, SUS and RUS results, and videotape of the interaction between the subject and RMT will be corroborated post-hoc.
- Sample Size We estimate the sample size of this study to be approximately 20 subjects. Since no direct comparison is being made to a control cohort, no inferential statistical analysis will be performed. This means that there is no meaningful way to appropriately power the study via sample size adjustments. Our choice of 20 subjects, therefore, was based on balancing the logistics required to test this platform with collecting sufficient data to understand the usability of then system.
- Randomization N/A
- Blinding N/A
- Initial Orientation Session Subjects will be given a brief video tutorial on how to connect the Kinect camera to the television and laptop, power on the RMT and Kinect camera, and operate the RMT hardware and software by research staff; any questions will be answered at that time regarding RMT operation. Then, subjects will be evaluated by a licensed, currently practicing physical therapist and shown the four exercises they will perform in the session. The therapist will work with each of the patients until they achieve a satisfactory performance in each of the exercises, as assessed by the therapist.
- Components
- Hardware:
- Kinect Camera
- LCD Television
- Laptop PC
- Software:
- Windows 7 Operating System
- Rehabilitation Measurement Tool Software Application
- Statistical Analysis:
The primary goal of this research is to understand the usability and reliability of the system. Since the present application is relatively novel, there are no standard mthods to 'success' or 'failure' of the system. Therefore, we do not intend to perform any inferential statistical analyses. Rather, we will generate descriptive statistics to be used in a post-hoc fashion to determine system reliability, and usability for future applications to sick patients undergoing physical therapy for post-ACL reconstruction surgery. Descriptive statistics provide better insight into the data allowing a more informed assessment of potential risks of the system. Understanding the distributional nature of the data (e.g., normal symmetric, normal skewed, bimodal, etc.) and the variability of the data scores can better identify overall safety risks as well as help to specify individuals that could potentially incur a greater safety risk, should one exist.
- Conditions
- Healthy Normals
- Being tested
- Rehabilitation Measurement Tool
- Keywords
- rehabilitation, physical therapy, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Measurement ToolDevice
The Rehabilitation Measurement Tool represents a telerehabilitation tool for physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Measurement Tool | This single arm consists of all subjects which will interact with the tool under invstigation. Receives: Device: Rehabilitation Measurement Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
We have designed and plan to implement a measure, which quantifies the length of time for the subject to set-up and initialize the system which will be used to test inter-reliability of patients using the Reflexion Measurement Tool to complete the exercise protocol. After the patient completes the exercise protocol we will ask the patient to complete the Reflexion Usability Scale to provide their user feedback and experience.
Measured: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol
Secondary outcomes (1)
Usability
The number of interactions required by the study coordinator in order for the subject to correctly set up, initialize and complete the set protocol of physical therapy exercises using the Rehabilitation Measurement Tool. The study coordinator will use the Reflexion Usability Scale to quantify and measure outcome while subject is using the system to complete the exercise protocol.
Measured: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Healthy NormalsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reflexion Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727856
- Sponsor's protocol ID
- NMCSD.2012.0060
- Other IDs
- NIH CTSA 8KL2TR000110-05
- Status last verified
- Nov 2014
- First submitted
- 1 Nov 2012
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hurley MV, Walsh NE, Mitchell H, Nicholas J, Patel A. Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial. Arthritis Care Res (Hoboken). 2012 Feb;64(2):238-47. doi: 10.1002/acr.20642.
PubMed 21954131Jan MH, Hung JY, Lin JC, Wang SF, Liu TK, Tang PF. Effects of a home program on strength, walking speed, and function after total hip replacement. Arch Phys Med Rehabil. 2004 Dec;85(12):1943-51. doi: 10.1016/j.apmr.2004.02.011.
PubMed 15605331Jette DU, Jette AM. Physical therapy and health outcomes in patients with knee impairments. Phys Ther. 1996 Nov;76(11):1178-87. doi: 10.1093/ptj/76.11.1178.
PubMed 8911431Harris GR, Susman JL. Managing musculoskeletal complaints with rehabilitation therapy: summary of the Philadelphia Panel evidence-based clinical practice guidelines on musculoskeletal rehabilitation interventions. J Fam Pract. 2002 Dec;51(12):1042-6.
PubMed 12540330Fischer DA, Tewes DP, Boyd JL, Smith JP, Quick DC. Home based rehabilitation for anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1998 Feb;(347):194-9.
PubMed 9520889Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don't patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001 Feb;55(2):132-8. doi: 10.1136/jech.55.2.132.
PubMed 11154253Jette AM, Rooks D, Lachman M, Lin TH, Levenson C, Heislein D, Giorgetti MM, Harris BA. Home-based resistance training: predictors of participation and adherence. Gerontologist. 1998 Aug;38(4):412-21. doi: 10.1093/geront/38.4.412.
PubMed 9726128Fitzgerald GK. Therapeutic exercise for knee osteoarthritis: considering factors that may influence outcome. Eura Medicophys. 2005 Jun;41(2):163-71.
PubMed 16200033Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007 Oct 15;57(7):1245-53. doi: 10.1002/art.23009.
PubMed 17907210Rand D, Kizony R, Weiss PT. The Sony PlayStation II EyeToy: low-cost virtual reality for use in rehabilitation. J Neurol Phys Ther. 2008 Dec;32(4):155-63. doi: 10.1097/NPT.0b013e31818ee779.
PubMed 19265756Burke, J. W. et al. Optimising engagement for stroke rehabilitation using serious games. Vis Comput 25, 1085-1099 (2009).
Pisters MF, Veenhof C, Schellevis FG, Twisk JW, Dekker J, De Bakker DH. Exercise adherence improving long-term patient outcome in patients with osteoarthritis of the hip and/or knee. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1087-94. doi: 10.1002/acr.20182.
PubMed 20235201Zhiqiang Luo; Chee Kian Lim; Weiting Yang; Ke Yen Tee; Kang Li; Chao Gu; Kim Doang Nguen; I-Ming Chen; Song Huat Yeo; ,
Zhou, H. Human motion tracking for rehabilitation--A survey. Biomedical Signal Processing and Control (2008).
Papastergiou, M. Exploring the potential of computer and video games for health and physical education: A literature review. Computers & Education 53, 603-622 (2009).
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Novel Motion Tracking Enabled Knee Physical Therapy Application With Healthy Patients to Assess Reliability and Usability
- ClinicalTrials.gov ID
- NCT01727856
- Acronym / sponsor ID
- NMCSD.2012.0060
- Conditions
- Healthy Normals
- Keywords
- rehabilitation, physical therapy, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Reflexion Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Naval Medical Center, San Diego
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- First posted
- 16 Nov 2012 (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.
Rehabilitation exercise conducted at home following injury improves clinical and functional outcomes. Optimum compliance with prescribed exercise regimens requires regular patient instruction, performance assessment, monitoring and general encouragement from healthcare staff. Exercise at home though convenient for patients is not conducive for provision of the professional support needed to maximize prescribed regimen effectiveness.
Software in development by Reflexion Health Inc. along with the Naval Medical Center San Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during at-home rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware platform for the designed software package tentatively called, "Reflexion." Kinect® contains a marker-less/controller-less motion tracking camera. The final Reflexion software will rely on a "Rehabilitation Measurement Tool (RMT)" to detect cardinal plane skeletal joint movement and its velocity utilizing the embedded Kinect® camera while also providing patient visual feedback via an avatar on a television screen.
In this observational minimal risk study, RMT/Kinect® functional reliability and usability will be assessed. Twenty healthy subjects will physically set-up and turn-on the hardware/software system; receive exercise directions from the RMT; then conduct a series of knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair.
An initial limited data set, obtained by Reflexion Health, provided validity and reliability measures. Eighteen degrees of absolute difference was detected between manual goniometry and Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise. Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A correctable systematic bias toward underestimation by the RMT will allow for future more accurate estimations of joint positioning improving face validity.
RMT functional reliability and general usability will be expressed in this study utilizing descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect® camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software errors and failure will tallied and measured to ascertain RMT reliability.
User-RMT interaction quality will be evaluated with video recordings of each set-up and exercise session. Specifically, usability measures will include: need for additional assistance setting-up or operating the RMT; number of attempts required by the subject to interact with a specific feature: time spent on specific elements during the session. Participant feedback will be elicited post-session using two scaled questionnaires: System Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide software modifications needed prior to implementation of future clinical studies within the NMCSD population.
Detailed description
- General Approach: We plan on using an observational study design to assess the reliability and usability of the RMT by healthy volunteers as they participate in a simulated session of knee physical therapy as presented by the RMT. Each session will be supervised by research staff and recorded for later review and assessment of areas of concern for reliability and usability.
- Methods: The study will use 20 (n=20) healthy volunteers. These subjects will be actively recruited from Naval Medical Center San Diego and Orthopedic by research staff. We will also use an informational flyer placed in the NMCSD Physical Therapy and Orthopedic outpatient clinic waiting room. No medical records will be used to identify subjects for recruitment. Subjects will be approached by research staff and will be asked about participation and will undergo standard practices regarding meeting, inclusion and exclusion criteria and clinical trial consent by trained research staff. Those who consent to participate will be taken to an area that houses the RMT hardware and software. Subjects will then undergo a brief 5 minute tutorial on the setup, power-on, and navigation of the hardware and gesture controlled software. After the orientation session each subject will be presented the RMT hardware and asked to connect the hardware components via provided cables and subsequently power on the system and application as well as position themselves correctly in front of the camera. Next, they will be instructed to follow the on screen prompts to enter their subject ID and pertinent login information and navigate the system using gestures. Following the setup process they will then proceed to engage in four exercises sequentially presented by the RMT software. Approximately 5 repetitions of each exercise will be recorded and evaluated by the RMT after which the subject will be asked to follow the onscreen prompts to review a summary of their activity as presented by the RMT and exit the application. After their interaction with the RMT they will be asked to complete a System Usability Scale questionnaire as well as a Reflexion Usability Scale questionnaire. We anticipate the total time required by each subject will be approximately 45 minutes. Research staff will be available to provide any assistance as requested by the subjects in their interaction with the RMT. Additionally, staff will also intervene while consented subjects perform the exercises if they detect any signs of impending injury or harm. Subjects will be allowed to terminate their involvement at any time and for any reason. Review of the research staff notes during the subject interaction with the RMT, SUS and RUS results, and videotape of the interaction between the subject and RMT will be corroborated post-hoc.
- Sample Size We estimate the sample size of this study to be approximately 20 subjects. Since no direct comparison is being made to a control cohort, no inferential statistical analysis will be performed. This means that there is no meaningful way to appropriately power the study via sample size adjustments. Our choice of 20 subjects, therefore, was based on balancing the logistics required to test this platform with collecting sufficient data to understand the usability of then system.
- Randomization N/A
- Blinding N/A
- Initial Orientation Session Subjects will be given a brief video tutorial on how to connect the Kinect camera to the television and laptop, power on the RMT and Kinect camera, and operate the RMT hardware and software by research staff; any questions will be answered at that time regarding RMT operation. Then, subjects will be evaluated by a licensed, currently practicing physical therapist and shown the four exercises they will perform in the session. The therapist will work with each of the patients until they achieve a satisfactory performance in each of the exercises, as assessed by the therapist.
- Components
- Hardware:
- Kinect Camera
- LCD Television
- Laptop PC
- Software:
- Windows 7 Operating System
- Rehabilitation Measurement Tool Software Application
- Statistical Analysis:
The primary goal of this research is to understand the usability and reliability of the system. Since the present application is relatively novel, there are no standard mthods to 'success' or 'failure' of the system. Therefore, we do not intend to perform any inferential statistical analyses. Rather, we will generate descriptive statistics to be used in a post-hoc fashion to determine system reliability, and usability for future applications to sick patients undergoing physical therapy for post-ACL reconstruction surgery. Descriptive statistics provide better insight into the data allowing a more informed assessment of potential risks of the system. Understanding the distributional nature of the data (e.g., normal symmetric, normal skewed, bimodal, etc.) and the variability of the data scores can better identify overall safety risks as well as help to specify individuals that could potentially incur a greater safety risk, should one exist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Measurement Tool | – | Device: Rehabilitation Measurement ToolThis single arm consists of all subjects which will interact with the tool under invstigation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy males and femailes, ages 18-35
Key inclusion criteria (2 listed)
- Healthy Males and Females
- Age 18-35
Key exclusion criteria (11 listed)
- Active knee symptoms
- Enrollment in knee physical therapy within 3 months of evaluation
- External or implanted lower extremity prosthetics
- Administration of regularly scheduled pain medication for lower extremities including oral, topical, or intra-articular routes of delivery
- Surgery or procedures within 3 months prior to enrollment
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 |
|---|---|---|
| Rehabilitation Measurement ToolThe Rehabilitation Measurement Tool represents a telerehabilitation tool for physical therapy. | Device | Rehabilitation Measurement Tool |
Primary outcome
Reliability
Time frame: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol
We have designed and plan to implement a measure, which quantifies the length of time for the subject to set-up and initialize the system which will be used to test inter-reliability of patients using the Reflexion Measurement Tool to complete the exercise protocol. After the patient completes the exercise protocol we will ask the patient to complete the Reflexion Usability Scale to provide their user feedback and experience.
1 secondary outcome
Usability
Time frame: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol
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 6 Nov 2014.
- Background: PubMed 21954131Hurley MV, Walsh NE, Mitchell H, Nicholas J, Patel A. Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial. Arthritis Care Res (Hoboken). 2012 Feb;64(2):238-47. doi: 10.1002/acr.20642.
- Background: PubMed 15605331Jan MH, Hung JY, Lin JC, Wang SF, Liu TK, Tang PF. Effects of a home program on strength, walking speed, and function after total hip replacement. Arch Phys Med Rehabil. 2004 Dec;85(12):1943-51. doi: 10.1016/j.apmr.2004.02.011.
- Background: PubMed 8911431Jette DU, Jette AM. Physical therapy and health outcomes in patients with knee impairments. Phys Ther. 1996 Nov;76(11):1178-87. doi: 10.1093/ptj/76.11.1178.
- Background: PubMed 12540330Harris GR, Susman JL. Managing musculoskeletal complaints with rehabilitation therapy: summary of the Philadelphia Panel evidence-based clinical practice guidelines on musculoskeletal rehabilitation interventions. J Fam Pract. 2002 Dec;51(12):1042-6.
- Background: PubMed 9520889Fischer DA, Tewes DP, Boyd JL, Smith JP, Quick DC. Home based rehabilitation for anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1998 Feb;(347):194-9.
- Background: PubMed 11154253Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don't patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001 Feb;55(2):132-8. doi: 10.1136/jech.55.2.132.
- Background: PubMed 9726128Jette AM, Rooks D, Lachman M, Lin TH, Levenson C, Heislein D, Giorgetti MM, Harris BA. Home-based resistance training: predictors of participation and adherence. Gerontologist. 1998 Aug;38(4):412-21. doi: 10.1093/geront/38.4.412.
- Background: PubMed 16200033Fitzgerald GK. Therapeutic exercise for knee osteoarthritis: considering factors that may influence outcome. Eura Medicophys. 2005 Jun;41(2):163-71.
- Background: PubMed 17907210Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007 Oct 15;57(7):1245-53. doi: 10.1002/art.23009.
- Background: PubMed 19265756Rand D, Kizony R, Weiss PT. The Sony PlayStation II EyeToy: low-cost virtual reality for use in rehabilitation. J Neurol Phys Ther. 2008 Dec;32(4):155-63. doi: 10.1097/NPT.0b013e31818ee779.
- BackgroundBurke, J. W. et al. Optimising engagement for stroke rehabilitation using serious games. Vis Comput 25, 1085-1099 (2009).
- Results publication: PubMed 20235201Pisters MF, Veenhof C, Schellevis FG, Twisk JW, Dekker J, De Bakker DH. Exercise adherence improving long-term patient outcome in patients with osteoarthritis of the hip and/or knee. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1087-94. doi: 10.1002/acr.20182.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Normals, run by Reflexion Health, Inc. 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 11 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 6 Nov 2014. 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?
Reliability (time frame: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol). 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 NCT01727856, which also lists 30 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 6 Nov 2014.