Osteoarthritis, KneeKCTRSNCT04191798

Study of the KinexConnect Telerehabilitation System (KCTRS)

A study testing Telerehabilitation using the KinexConnect system for rehabilitation after TKA. and Traditional outpatient PT for rehabilitation after TKA. in people with Osteoarthritis, Knee, run by Kinex Medical Company, LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA). Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Telerehabilitation using the KinexConnect system for rehabilitation after TKA. and Traditional outpatient PT for rehabilitation after TKA.
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 30 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Planned for a primary unilateral TKA.
At least 21 years of age.
Capable of understanding the study requirements and giving written informed consent.
Willing and able to comply with either therapy program.
Has easy access to caregiver support.

Who cannot join

Active range-of-motion (ARoM) < 80 degrees in target knee.
Unable to read and write in English.
Lack of email capability to receive recovery trend information.
Previous knee intervention in target knee.
Previous knee joint infection in either knee.
Received a revision TKA (opposite knee).

Show all 11Show fewer

Planned for bilateral TKA.
Self-reported pregnancy.
Reason for arthroplasty being for the treatment of fracture, infection or malignancy.
Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed.
Unwilling to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site

Des Moines Orthopedic Surgeons
Des Moines, Iowa, 50266

Other trials in United States

About this study

Official title: Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty

Read the detailed description

The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.

Conditions: Osteoarthritis, Knee
Being tested: Telerehabilitation using the KinexConnect system for rehabilitation after TKA., Traditional outpatient PT for rehabilitation after TKA.
Keywords: Arthroplasty, Knee Replacement, Rehab at home, Virtual PT, Remote Patient Monitoring, Patient Engagement, TKR, TKA
Medical subject headings: Osteoarthritis, Knee, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telerehabilitation using the KinexConnect system for rehabilitation after TKA.Behavioural
KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.
Traditional outpatient PT for rehabilitation after TKA.Behavioural
Control subjects are asked to undergo standard outpatient physical therapy (PT) with a licensed physical therapist plus supplemental home exercises as directed. Nominally patients are expected to have 3 PT sessions per week for 4 weeks.

Study groups in NCT04191798
Study group	Role	What they receive
KinexConnect	Experimental	Rehab at Home Patients Receives: Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.
Outpatient PT	Active comparator	In-person PT patients Receives: Behavioral: Traditional outpatient PT for rehabilitation after TKA.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Timed up and Go (TUG) Test score
The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.
Measured: 3 months
Change in the Timed up and Go (TUG) Test score
The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.
Measured: 1 year
Economic Benefit
Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.
Measured: 3 months
Economic Benefit
Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.
Measured: 1 year

Secondary outcomes (5)

Change in Active Range of Motion (ARoM)
Active Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve with independent effort
Measured: 3 months and 6 months
Change in Passive Range of Motion (PRoM)
Passive Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve when bearable force is exerted by the clinician.
Measured: 3 months and 6 months
Change in Pain as measured by the Verbal Descriptive Scale (VDS)
This is a self reported outcome by the patient based on their expression of pain at a given time point when presented with the 7 verbal cues.
The levels of pain reported vary from "No Pain" to "Most Intense Pain Imaginable". Higher the intensity of pain, worse the outcome
Measured: 3 months and 1 year
Change in the Knee Osteoarthritis Outcome Score (KOOS)
The KOOS is a standardized and validated patient outcome score that assess functional limitation in patient with knee osteoarthritis. The survey questionnaire is filled out in its entirety by the patient.
The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 3 months and 1 year
Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation
The patient satisfaction and patient expectation scores are calculated by having the relevant sections of the survey questionnaire is filled out in its entirety by the patient.
Patient Satisfaction is scored 0 - 40 points and Patient Expectation is scored 0 -15 points. with Zero being the worst outcome.
Measured: 3 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201930 Apr 2023

First posted10 Dec 2019
Study start1 Nov 2019
Primary completion31 Oct 2022 (estimated)
Study completion30 Apr 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04191798
Sponsor's protocol ID: KC-07
Acronym: KCTRS
Status last verified: Jun 2022
First submitted: 4 Dec 2019
Last updated: 22 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review. J Med Internet Res. 2017 Apr 28;19(4):e142. doi: 10.2196/jmir.6836.
PubMed 28455277
Shukla H, Nair SR, Thakker D. Role of telerehabilitation in patients following total knee arthroplasty: Evidence from a systematic literature review and meta-analysis. J Telemed Telecare. 2017 Feb;23(2):339-346. doi: 10.1177/1357633X16628996. Epub 2016 Jul 9.
PubMed 26843466
Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27.
PubMed 28027679
Kline PW, Melanson EL, Sullivan WJ, Blatchford PJ, Miller MJ, Stevens-Lapsley JE, Christiansen CL. Improving Physical Activity Through Adjunct Telerehabilitation Following Total Knee Arthroplasty: Randomized Controlled Trial Protocol. Phys Ther. 2019 Jan 1;99(1):37-45. doi: 10.1093/ptj/pzy119.
PubMed 30329126
Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28.
PubMed 25765130
Rondon AJ, Phillips JLH, Fillingham YA, Gorica Z, Austin MS, Courtney PM. Bundled Payments Are Effective in Reducing Costs Following Bilateral Total Joint Arthroplasty. J Arthroplasty. 2019 Jul;34(7):1317-1321.e2. doi: 10.1016/j.arth.2019.03.041. Epub 2019 Mar 28.
PubMed 30992236
Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: A randomized control study. J Telemed Telecare. 2017 Feb;23(2):239-247. doi: 10.1177/1357633X16634518. Epub 2016 Jul 9.
PubMed 26940798
Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
PubMed 26178888
Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Home-based Rehabilitation With A Novel Digital Biofeedback System versus Conventional In-person Rehabilitation after Total Knee Replacement: a feasibility study. Sci Rep. 2018 Jul 26;8(1):11299. doi: 10.1038/s41598-018-29668-0.
PubMed 30050087
Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.
PubMed 30816849
Fleischman AN, Crizer MP, Tarabichi M, Smith S, Rothman RH, Lonner JH, Chen AF. 2018 John N. Insall Award: Recovery of Knee Flexion With Unsupervised Home Exercise Is Not Inferior to Outpatient Physical Therapy After TKA: A Randomized Trial. Clin Orthop Relat Res. 2019 Jan;477(1):60-69. doi: 10.1097/CORR.0000000000000561.
PubMed 30794229
Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Belzile EL, Ranger P, Dimentberg R. Patient Satisfaction with In-Home Telerehabilitation After Total Knee Arthroplasty: Results from a Randomized Controlled Trial. Telemed J E Health. 2017 Feb;23(2):80-87. doi: 10.1089/tmj.2016.0060. Epub 2016 Aug 16.
PubMed 27529575
Tousignant M, Moffet H, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. Cost analysis of in-home telerehabilitation for post-knee arthroplasty. J Med Internet Res. 2015 Mar 31;17(3):e83. doi: 10.2196/jmir.3844.
PubMed 25840501
Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R. Effect of Inpatient Rehabilitation vs a Monitored Home-Based Program on Mobility in Patients With Total Knee Arthroplasty: The HIHO Randomized Clinical Trial. JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224.
PubMed 28291891

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT04191798
Acronym / sponsor ID: KCTRS / KC-07
Conditions: Osteoarthritis, Knee
Keywords: Arthroplasty, Knee Replacement, Rehab at home, Virtual PT, Remote Patient Monitoring, Patient Engagement, TKR, TKA
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Kinex Medical Company, LLCIndustry (pharma, biotech, devices)
Collaborators: Health Factors Inc
Study start: 1 Nov 2019 (actual)
Primary completion: 31 Oct 2022 (estimated)
Study completion: 30 Apr 2023 (estimated)
First posted: 10 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
KinexConnect	Experimental	Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.Rehab at Home Patients
Outpatient PT	Active comparator	Behavioral: Traditional outpatient PT for rehabilitation after TKA.In-person PT patients

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Planned for a primary unilateral TKA.
At least 21 years of age.
Capable of understanding the study requirements and giving written informed consent.
Willing and able to comply with either therapy program.
Has easy access to caregiver support.

Key exclusion criteria (11 listed)

Active range-of-motion (ARoM) < 80 degrees in target knee.
Unable to read and write in English.
Lack of email capability to receive recovery trend information.
Previous knee intervention in target knee.
Previous knee joint infection in either knee.

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
Telerehabilitation using the KinexConnect system for rehabilitation after TKA.KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.	Behavioural	KinexConnect
Traditional outpatient PT for rehabilitation after TKA.Control subjects are asked to undergo standard outpatient physical therapy (PT) with a licensed physical therapist plus supplemental home exercises as directed. Nominally patients are expected to have 3 PT sessions per week for 4 weeks.	Behavioural	Outpatient PT

Primary outcome

Change in the Timed up and Go (TUG) Test score
Time frame: 3 months
The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.
Change in the Timed up and Go (TUG) Test score
Time frame: 1 year
The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.
Economic Benefit
Time frame: 3 months
Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.
Economic Benefit
Time frame: 1 year
Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.

5 secondary outcomes

Change in Active Range of Motion (ARoM)
Time frame: 3 months and 6 months
Change in Passive Range of Motion (PRoM)
Time frame: 3 months and 6 months
Change in Pain as measured by the Verbal Descriptive Scale (VDS)
Time frame: 3 months and 1 year
Change in the Knee Osteoarthritis Outcome Score (KOOS)
Time frame: 3 months and 1 year
Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation
Time frame: 3 months and 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Background: PubMed 28455277Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review. J Med Internet Res. 2017 Apr 28;19(4):e142. doi: 10.2196/jmir.6836.
Background: PubMed 26843466Shukla H, Nair SR, Thakker D. Role of telerehabilitation in patients following total knee arthroplasty: Evidence from a systematic literature review and meta-analysis. J Telemed Telecare. 2017 Feb;23(2):339-346. doi: 10.1177/1357633X16628996. Epub 2016 Jul 9.
Background: PubMed 28027679Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27.
Background: PubMed 30329126Kline PW, Melanson EL, Sullivan WJ, Blatchford PJ, Miller MJ, Stevens-Lapsley JE, Christiansen CL. Improving Physical Activity Through Adjunct Telerehabilitation Following Total Knee Arthroplasty: Randomized Controlled Trial Protocol. Phys Ther. 2019 Jan 1;99(1):37-45. doi: 10.1093/ptj/pzy119.
Background: PubMed 25765130Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28.
Results publication: PubMed 30992236Rondon AJ, Phillips JLH, Fillingham YA, Gorica Z, Austin MS, Courtney PM. Bundled Payments Are Effective in Reducing Costs Following Bilateral Total Joint Arthroplasty. J Arthroplasty. 2019 Jul;34(7):1317-1321.e2. doi: 10.1016/j.arth.2019.03.041. Epub 2019 Mar 28.
Results publication: PubMed 26940798Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: A randomized control study. J Telemed Telecare. 2017 Feb;23(2):239-247. doi: 10.1177/1357633X16634518. Epub 2016 Jul 9.
Results publication: PubMed 26178888Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
Results publication: PubMed 30050087Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Home-based Rehabilitation With A Novel Digital Biofeedback System versus Conventional In-person Rehabilitation after Total Knee Replacement: a feasibility study. Sci Rep. 2018 Jul 26;8(1):11299. doi: 10.1038/s41598-018-29668-0.
Results publication: PubMed 30816849Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.
Results publication: PubMed 30794229Fleischman AN, Crizer MP, Tarabichi M, Smith S, Rothman RH, Lonner JH, Chen AF. 2018 John N. Insall Award: Recovery of Knee Flexion With Unsupervised Home Exercise Is Not Inferior to Outpatient Physical Therapy After TKA: A Randomized Trial. Clin Orthop Relat Res. 2019 Jan;477(1):60-69. doi: 10.1097/CORR.0000000000000561.
Results publication: PubMed 27529575Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Belzile EL, Ranger P, Dimentberg R. Patient Satisfaction with In-Home Telerehabilitation After Total Knee Arthroplasty: Results from a Randomized Controlled Trial. Telemed J E Health. 2017 Feb;23(2):80-87. doi: 10.1089/tmj.2016.0060. Epub 2016 Aug 16.
SURGICAL MANAGEMENT OF OSTEOARTHRITIS OF THE KNEE EVIDENCE-BASED CLINICAL PRACTICE GUIDELINELink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barron Bremner, DO principal investigator

Des Moines Orthopedic Suregons

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: status not confirmed, as of the sponsor's last update on 22 Jun 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?

Change in the Timed up and Go (TUG) Test score (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04191798, which also lists 14 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 22 Jun 2022.