Transfemoral AmputationMDORPNCT02891707

Mobile Device Outcomes-based Rehabilitation Program

A study testing Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) in people with Transfemoral Amputation and Transtibial Amputation, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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Trial summary

Who is it for?: Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Transfemoral Amputation, Transtibial Amputation
What is being tested?: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: May 2016to May 2020
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 20 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

DEERS eligible Veterans/SMs with major unilateral or bilateral lower limb loss at the Symes, Transtibial, Knee Disarticulation, and/or Transfemoral amputation levels
At least 3 months from initial prosthetic fitting and cleared for at home prosthetic use.
Male and Females between 20 - 80 years of age
Determined to be medically stable before participation in the study
Currently have a well-fitting and properly aligned prosthesis
Can independently perform exercises at home

Show all 10Show fewer

Demonstrate basic proficiency with use of tablet technology
DEERS Eligible males and females between 20-65 years of age
Determined to be medically stable before participation in the study
No history of upper or lower limb loss

Who cannot join

Spinal cord injury or lower limb paralysis
Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury
Cognitively unable to complete the self-report questionnaires or use tablet technology
No valid contact information
Amputation of only toes or upper limb only
Amputation of upper and lower limb

Show all 21Show fewer

The subject is deemed as living too far away for the physical therapist to conduct home visits.
Evidence of any nerve or brain disorders that affect motion
Unable to speak or understand English
The subject does not have the capacity to provide consent.
The following inclusion and exclusion criteria will be used to determine eligibility for the CONTROL subjects to participate in phase I of the study at WRNMMC.
Evidence of paralysis or other lower limb dysfunction.
Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury
Cognitively unable to follow study instructions
Amputation of upper or lower limb
Unable to walk 100 meters without an assistive device (cane, walker, etc)
History of cardiovascular disease that would limit ambulation 100 meters
Reported symptoms of chest pain or shortness of breath
Evidence of any nerve or brain disorders that affect motion
Unable to speak or understand English
The subject does not have the capacity to provide consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889

Other trials in United States

About this study

This joint research project between the Department of Veterans Affairs (VA) and Department of Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based Rehabilitation Program (MDORP) will improve the quality of rehabilitative care at a decreased cost to the healthcare system and a reduced burden for service members (SMs) and veterans with lower limb loss. The development of the MDORP will be executed by a multisite translational clinical care team that will use web-based mobile computing devices designed to assess mobility, enable remote prescription of targeted exercise program, and provide continual measureable outcomes to document the continuum of care with the intent of maximizing prosthetic performance while minimizing adverse medical events. The information obtained from this web-based mobile device application will be used by clinicians to promote continuity of care from the DoD and VA facilities nationwide to the community and at home.

Conditions: Transfemoral Amputation, Transtibial Amputation
Being tested: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)

What participants receive

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

Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)Device
The study will use a novel piece of technology, the ReLOAD, which is a data collector system that uses instrumented insoles, custom, miniature (1"x1") microcontroller with accelerometer, gyroscopes, and geomagnetic sensors connected to a Bluetooth transceiver to collect and transmit gait kinematic data to mobile devices, such as an iPad and iPod. When a person walks or performs a specific activity, the ReLOAD system captures the movement, which can then be stored locally within the mobile device and/or encrypted and sent to a secured central server. This allows the patient or provider to access clinically relevant biomechanical data to help guide rehabilitation.

Study groups in NCT02891707
Study group	Role	What they receive
Control Group	Active comparator	The investigators will recruit 20 healthy subjects at Walter Reed National Military Medical Center (WRNMMC) with the goal of consenting and enrolling 15 healthy subjects to assess the reliability and validity the wearable Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) system. Receives: Device: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)
Amputee Group	Active comparator	The investigators will recruit a total of 130 subjects (65 at WRNMMC and 65 at the Miami VA) with the goal of consenting and enrolling 100 subjects (50 and WRNMMC and 50 at the Miami VA) with lower limb amputation to utilize the ReLOAD system. Receives: Device: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)

What is being measured

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

Change in Timed Up and Go (TUG)
The TUG is a measure of basic mobility that assesses the time to complete a sit to stand activity from a standard height chair, ambulate less than 10 feet, perform a turning activity, ambulate back to the chair and perform stand to sit activity. It is a measure of mobility and predictor of falls risk.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Change in Six-minute Walk Test (6MWT)
The 6MWT has been found to be a measure of overall mobility and physical functioning in the lower limb amputee population and geriatric population. It will be used to provide an overall measure of mobility and musculoskeletal endurance.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Change in Amputee Mobility Predictor (AMP)
The AMP is a 21 item clinical tool that assesses current functional capability and mobility with a prosthesis when performing basic daily activities. The AMP assesses the ability of an amputee to complete 20 different items that progress in level of difficulty. Higher AMP scores indicate greater prosthetic ambulation capabilities.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Change in Bilateral-Amputee Mobility Predictor (BAMP)
The BAMP is the AMP adapted for those with bilateral lower limb loss.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Change in Comprehensive High-level Activity Mobility Predictor (CHAMP)
The CHAMP is a clinical tool that assesses an individual's capabilities in performing high-level mobility and agility activities in multiple planes of motion. It consists of four tests (Single Limb Stance, Edgren Side Step Test, T-Test, and Illinois Agility Test) and generates a total score that indicates greater high-level mobility capabilities.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Change in Symmetry of External Work (SEW)
The SEW is a biomechanical outcome measure for assessing dynamic movement symmetry during functional activities. SEW values represent the effort undertaken by each lower-limb in moving the body forward during walking. It will be assessed simultaneously with the TUG, AMP, 6MWT, and CHAMP.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Change in Modified Test of Sensory Integration and Balance (mCTSIB)
The mCTSIB is a test to describe postural control under various sensory conditions. The test requires subjects to maintain balance for 30 seconds in four conditions: firm surface with eyes open, firm surface with eyes closed, standing on foam with eyes open, and standing on foam with eyes closed.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

Secondary outcomes (16)

Charleson Co-Morbidity Index
Description of Current Medical Conditions
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Bandura's Self-efficacy Survey
Self-motivation for exercise
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
New Injury Severity Score
History of the musculoskeletal injuries due to the participant's traumatic event will be documented using self-report and past and current medical records from each participant. The injuries will be categorized into anatomical body regions using the Abbreviated Injury Scale (AIS). The New Injury Severity Score (NISS) will be calculated using the AIS for each participant to determine injury severity.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Patient Reported Outcome Measure Information System (PROMIS)
Physical Function domains will be used to describe the participant's performance of standard activities of daily living, pain intensity, pain severity, fatigue with activities, and sleep disturbance. The PROMIS Mental Health domains will be used to describe the participant's current state of depression, anger, and anxiety with daily activities.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
International Physical Activity Questionnaire (IPAQ)
Physical Activity Questionnaire
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R)
The TAPES will be administered to the participants with lower limb loss in order to assess psychosocial adjustment, activity restriction, and satisfaction with their current prosthesis. It contains 33 self-reported items; psychosocial adjustment, 15 items; activity restriction, 10 items; and satisfaction, 8 items.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Prosthetic Limb Users Survey- Mobility (PLUS-M)
The PLUS-M is a self-report measure of mobility designed for prosthetic limb users to assess mobility performing different activities of daily living within the home and community.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Socket Fit Comfort Scale
Socket comfort and fit assessment.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Activities-specific balance confidence scale (ABC)
Measurement of balance confidence.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Modified Oswestry Low Back Pain Disability Index (MODI)
The MODI is a 10-item questionnaire that will be used to assess current presence and severity of low back pain with different daily activities.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Lower Extremity Functional Scale (LEFS)
The LEFS is a 20- item questionnaire that assesses one's ability to perform activities of daily life, functional mobility, balance, coordination, and range of motion/strength. It is scored on a 4 point scale for each question for a maximum score of 80.
Measured: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Height
Height in inches of participant will be collected.
Measured: Baseline
Weight
Weight in kilograms of the participant will be collected.
Measured: Baseline
Body Mass Index
Body Mass Index will be calculated for each participant using their height and weight.
Measured: Baseline
Waist Circumference
Waist Circumference in centimeters will be collected from each participant.
Measured: Baseline
Hip Circumference
Hip Circumference in centimeters will be collected from each participant.
Measured: Baseline

Timeline

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

May 2016May 2020

First posted7 Sep 2016 (estimated)
Study startMay 2016
Primary completionJun 2019 (estimated)
Study completionMay 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Transfemoral AmputationStudies 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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02891707
Sponsor's protocol ID: 407406
Acronym: MDORP
Status last verified: Jun 2019
First submitted: 24 Aug 2016
Last updated: 11 Jun 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Gaunaurd I, Kristal A, Horn A, Krueger C, Muro O, Rosenberg A, Gruben K, Kirk-Sanchez N, Pasquina P, Gailey R. The Utility of the 2-Minute Walk Test as a Measure of Mobility in People With Lower Limb Amputation. Arch Phys Med Rehabil. 2020 Jul;101(7):1183-1189. doi: 10.1016/j.apmr.2020.03.007. Epub 2020 Apr 6.
PubMed 32272105

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?

See locations

Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users

All Transfemoral Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Device Outcomes-based Rehabilitation Program
ClinicalTrials.gov ID: NCT02891707
Acronym / sponsor ID: MDORP / 407406
Conditions: Transfemoral Amputation, Transtibial Amputation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
Collaborators: Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, University of Miami, Miami VA Healthcare System
Study start: May 2016
Primary completion: Jun 2019 (estimated)
Study completion: May 2020 (estimated)
First posted: 7 Sep 2016 (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.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Group	Active comparator	Device: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)The investigators will recruit 20 healthy subjects at Walter Reed National Military Medical Center (WRNMMC) with the goal of consenting and enrolling 15 healthy subjects to assess the reliability and validity the wearable Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) system.
Amputee Group	Active comparator	Device: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)The investigators will recruit a total of 130 subjects (65 at WRNMMC and 65 at the Miami VA) with the goal of consenting and enrolling 100 subjects (50 and WRNMMC and 50 at the Miami VA) with lower limb amputation to utilize the ReLOAD system.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

DEERS eligible Veterans/SMs with major unilateral or bilateral lower limb loss at the Symes, Transtibial, Knee Disarticulation, and/or Transfemoral amputation levels
At least 3 months from initial prosthetic fitting and cleared for at home prosthetic use.
Male and Females between 20 - 80 years of age
Determined to be medically stable before participation in the study
Currently have a well-fitting and properly aligned prosthesis

Key exclusion criteria (21 listed)

Spinal cord injury or lower limb paralysis
Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury
Cognitively unable to complete the self-report questionnaires or use tablet technology
No valid contact information
Amputation of only toes or upper limb only

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
Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)The study will use a novel piece of technology, the ReLOAD, which is a data collector system that uses instrumented insoles, custom, miniature (1"x1") microcontroller with accelerometer, gyroscopes, and geomagnetic sensors connected to a Bluetooth transceiver to collect and transmit gait kinematic data to mobile devices, such as an iPad and iPod. When a person walks or performs a specific activity, the ReLOAD system captures the movement, which can then be stored locally within the mobile device and/or encrypted and sent to a secured central server. This allows the patient or provider to access clinically relevant biomechanical data to help guide rehabilitation.	Device	Amputee Group, Control Group

Primary outcome

Change in Timed Up and Go (TUG)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The TUG is a measure of basic mobility that assesses the time to complete a sit to stand activity from a standard height chair, ambulate less than 10 feet, perform a turning activity, ambulate back to the chair and perform stand to sit activity. It is a measure of mobility and predictor of falls risk.
Change in Six-minute Walk Test (6MWT)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The 6MWT has been found to be a measure of overall mobility and physical functioning in the lower limb amputee population and geriatric population. It will be used to provide an overall measure of mobility and musculoskeletal endurance.
Change in Amputee Mobility Predictor (AMP)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The AMP is a 21 item clinical tool that assesses current functional capability and mobility with a prosthesis when performing basic daily activities. The AMP assesses the ability of an amputee to complete 20 different items that progress in level of difficulty. Higher AMP scores indicate greater prosthetic ambulation capabilities.
Change in Bilateral-Amputee Mobility Predictor (BAMP)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The BAMP is the AMP adapted for those with bilateral lower limb loss.
Change in Comprehensive High-level Activity Mobility Predictor (CHAMP)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The CHAMP is a clinical tool that assesses an individual's capabilities in performing high-level mobility and agility activities in multiple planes of motion. It consists of four tests (Single Limb Stance, Edgren Side Step Test, T-Test, and Illinois Agility Test) and generates a total score that indicates greater high-level mobility capabilities.
Change in Symmetry of External Work (SEW)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The SEW is a biomechanical outcome measure for assessing dynamic movement symmetry during functional activities. SEW values represent the effort undertaken by each lower-limb in moving the body forward during walking. It will be assessed simultaneously with the TUG, AMP, 6MWT, and CHAMP.
Change in Modified Test of Sensory Integration and Balance (mCTSIB)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The mCTSIB is a test to describe postural control under various sensory conditions. The test requires subjects to maintain balance for 30 seconds in four conditions: firm surface with eyes open, firm surface with eyes closed, standing on foam with eyes open, and standing on foam with eyes closed.

16 secondary outcomes

Charleson Co-Morbidity Index
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Bandura's Self-efficacy Survey
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
New Injury Severity Score
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Patient Reported Outcome Measure Information System (PROMIS)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Prosthetic Limb Users Survey- Mobility (PLUS-M)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Socket Fit Comfort Scale
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Activities-specific balance confidence scale (ABC)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Modified Oswestry Low Back Pain Disability Index (MODI)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Lower Extremity Functional Scale (LEFS)
Time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Height
Time frame: Baseline
Weight
Time frame: Baseline
Body Mass Index
Time frame: Baseline
Waist Circumference
Time frame: Baseline
Hip Circumference
Time frame: Baseline

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Derived from this study: PubMed 32272105Gaunaurd I, Kristal A, Horn A, Krueger C, Muro O, Rosenberg A, Gruben K, Kirk-Sanchez N, Pasquina P, Gailey R. The Utility of the 2-Minute Walk Test as a Measure of Mobility in People With Lower Limb Amputation. Arch Phys Med Rehabil. 2020 Jul;101(7):1183-1189. doi: 10.1016/j.apmr.2020.03.007. Epub 2020 Apr 6.
Individual participant dataSharing planned: No

Related trials for Transfemoral Amputation

Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users

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.

Paul F Pasquina, MD principal investigator

Walter Reed National Military Medical Center, Uniformed Services Univesrity of the Health Sciences, Center for Rehabilitation Sciences Research

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 10 inclusion and 21 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 Jun 2019. 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 Timed Up and Go (TUG) (time frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up). The study lists 7 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 NCT02891707, which also lists 1 linked publication.

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 Jun 2019.