Injuries, Spinal CordWISENCT02943915
The WISE Trial - Walking Improvement for SCI With Exoskeleton
A study testing Ekso GT Rehabilitation Therapy and Body Weight Supported (BWS) Treadmill Training in people with Injuries, Spinal Cord, run by Ekso Bionics at 10 sites in United States.
Trial summary
A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Injuries, Spinal Cord
- What is being tested?
- Ekso GT Rehabilitation Therapy and Body Weight Supported (BWS) Treadmill Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2016to 10 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor incomplete paraplegia or tetraplegia
- Neurological level of injury (NLI) C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- Sufficient diaphragmatic strength such that respiration is not compromised with exercise.
- Sufficient upper extremity strength to use a front wheeled walker either by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5)
- AIS-C SCI \& AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- Ambulates at <0.44 meters/second with or without physical assistance and assistance device
Show all 16Show fewer
- WISCI ≥ 1
- 18 - 75 yrs, inclusive
- No current or history of other neurological conditions
- Screened and cleared by a physician
- Involved in standing program or must be able to tolerate at least 15 min upright
- Weigh 220 pounds (100kg) or less
- Be able to fit into the Ekso device
- Approximately between 5'0" and 6'4" tall
- Standing hip width of approximately 18" or less
- Have near normal range of motion in hips, knees and ankles
Who cannot join
- AIS-A SCI or AIS-B SCI
- Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
- < 3 months since previous intensive gait training regimen
- Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
- Currently involved in another intervention study
- Concurrent neurological disease
Show all 28Show fewer
- Hip flexion contracture greater than ~17°
- Knee flexion contracture greater than 12°
- Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)
- Leg length discrepancy
- Greater than 0.5" for upper leg
- Greater than 0.75" for lower leg
- Spinal instability
- Unresolved deep vein thrombosis
- Uncontrolled autonomic dysreflexia
- Severe muscular or skeletal pain
- Spasticity that prevents joint motion (severe stiffness or rigidity,) where both legs have a Modified Ashworth Score (MAS) score of 3 or higher for half or more of their proximal lower extremity muscles; proximal muscles include hip flexors/extensors/adductors and knee flexors/extensors.
- Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
- Pregnancy
- Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
- Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)
- Participant requires the assistance of more than one therapist to transfer safely.
- Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting to standing
- Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
- Colostomy
- History of long bone fractures since the SCI, secondary to osteoporosis
- Unable to sustain current medication regimen
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Kennedy Kruger Institute
Baltimore, Maryland, 21211
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Rehabilitation Institute of Michigan
Detroit, Michigan, 48201
TIRR Memorial Hermann Hospital
Houston, Texas, 77030
Courage Kenny Research Center
Minneapolis, Minnesota, 55407
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Gaylord Hospital
Wallingford, Connecticut, 06492
Kessler Foundation
West Orange, New Jersey, 07052
Marianjoy Rehabilitation Hospital
Wheaton, Illinois, 60187
Burke Medical Research Institute
White Plains, New York, 10605
About this study
A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury
Read the detailed description
Community dwelling iSCI participants may improve clinical gait function by engaging in a gait training regimen, where robotic exoskeletons can readily deliver a precise dose and simultaneously reduce the physical stress imposed on therapists using conventional manually assisted stepping practice. Exoskeleton training is predicted to improve function in participants receiving usual care, but not superior to intensity-matched manual training. The rationale to implement exoskeleton robotics as preference in gait training is based on precision dosing, over-ground training, and reduced therapist burden for high repetition training.
The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The objectives of this study are the following:
- Primary Objective:
To demonstrate that a 12 week robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in community dwelling participants with chronic iSCI.
- Secondary Objectives:
- To examine the economic factors such as number of physical therapists/staff required during training.
- To analyze the physical burden on therapists assisting and supervising during training.
- To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI population (demographic, clinical, functional, psychological, balance, etc.).
- Conditions
- Injuries, Spinal Cord
- Being tested
- Ekso GT Rehabilitation Therapy, Body Weight Supported (BWS) Treadmill Training
- Keywords
- Spinal Cord, Injury, Exoskeleton, Ekso, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ekso GT Rehabilitation TherapyDevice
Also called Exoskeleton
Walking Improvement for Spinal Cord Injuries with Exoskeleton
Body Weight Supported (BWS) Treadmill TrainingDevice
Also called Conventional Therapy
Standard gait training using BWS PT and overground training
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Experimental | Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy Receives: Device: Ekso GT Rehabilitation Therapy |
| Group 2: Active controls - BWSTT Therapy | Active comparator | Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training Receives: Device: Body Weight Supported (BWS) Treadmill Training |
| Group 3: Passive controls | No intervention | Participants in this group continue with normal daily activities over 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)
The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.
Measured: Baseline and 12 Weeks
Secondary outcomes (5)
Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks
Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks.
Measured: Between baseline and 24 weeks
Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks
6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline.
Measured: Baseline-24 weeks
Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up
Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline.
Measured: Baseline and 24 weeks
Number of Participants Who Experienced a Fall During Protocol
At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall.
Measured: Throughout 24 weeks
Change in Berg Balance Scale Score From Baseline to 24 Weeks
Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline.
Measured: Baseline-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Injuries, Spinal CordStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekso Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Burke Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Dylan Edwards, PhD, Principal investigator, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943915
- Sponsor's protocol ID
- 105333
- Acronym
- WISE
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2016
- Last updated
- 31 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stampacchia G, Rustici A, Bigazzi S, Gerini A, Tombini T, Mazzoleni S. Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons. NeuroRehabilitation. 2016 Jun 27;39(2):277-83. doi: 10.3233/NRE-161358.
PubMed 27372363Gad PN, Gerasimenko YP, Zdunowski S, Sayenko D, Haakana P, Turner A, Lu D, Roy RR, Edgerton VR. Iron 'ElectriRx' man: Overground stepping in an exoskeleton combined with noninvasive spinal cord stimulation after paralysis. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1124-7. doi: 10.1109/EMBC.2015.7318563.
PubMed 26736463Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12.
PubMed 26364280Kressler J, Thomas CK, Field-Fote EC, Sanchez J, Widerstrom-Noga E, Cilien DC, Gant K, Ginnety K, Gonzalez H, Martinez A, Anderson KD, Nash MS. Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury. Arch Phys Med Rehabil. 2014 Oct;95(10):1878-1887.e4. doi: 10.1016/j.apmr.2014.04.026. Epub 2014 May 17.
PubMed 24845221Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
PubMed 26818847Kolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoTM bionic exoskeleton to aid ambulation after spinal cord injury. Spine. 2013 doi.org/10.4172/2165-7939.S4-003
Forrest GF, Hutchinson K, Lorenz DJ, Buehner JJ, Vanhiel LR, Sisto SA, Basso DM. Are the 10 meter and 6 minute walk tests redundant in patients with spinal cord injury? PLoS One. 2014 May 1;9(5):e94108. doi: 10.1371/journal.pone.0094108. eCollection 2014.
PubMed 24788068
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WISE Trial - Walking Improvement for SCI With Exoskeleton
- ClinicalTrials.gov ID
- NCT02943915
- Acronym / sponsor ID
- WISE / 105333
- Conditions
- Injuries, Spinal Cord
- Keywords
- Spinal Cord, Injury, Exoskeleton, Ekso, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ekso BionicsIndustry (pharma, biotech, devices)
- Collaborators
- Burke Medical Research Institute
- Study start
- Sep 2016
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Posted 31 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury
Detailed description
Community dwelling iSCI participants may improve clinical gait function by engaging in a gait training regimen, where robotic exoskeletons can readily deliver a precise dose and simultaneously reduce the physical stress imposed on therapists using conventional manually assisted stepping practice. Exoskeleton training is predicted to improve function in participants receiving usual care, but not superior to intensity-matched manual training. The rationale to implement exoskeleton robotics as preference in gait training is based on precision dosing, over-ground training, and reduced therapist burden for high repetition training.
The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The objectives of this study are the following:
- Primary Objective:
To demonstrate that a 12 week robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in community dwelling participants with chronic iSCI.
- Secondary Objectives:
- To examine the economic factors such as number of physical therapists/staff required during training.
- To analyze the physical burden on therapists assisting and supervising during training.
- To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI population (demographic, clinical, functional, psychological, balance, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Experimental | Device: Ekso GT Rehabilitation TherapyParticipants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy |
| Group 2: Active controls - BWSTT Therapy | Active comparator | Device: Body Weight Supported (BWS) Treadmill TrainingParticipants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training |
| Group 3: Passive controls | No intervention | –Participants in this group continue with normal daily activities over 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Motor incomplete paraplegia or tetraplegia
- Neurological level of injury (NLI) C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- Sufficient diaphragmatic strength such that respiration is not compromised with exercise.
- Sufficient upper extremity strength to use a front wheeled walker either by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5)
- AIS-C SCI \& AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
Key exclusion criteria (28 listed)
- AIS-A SCI or AIS-B SCI
- Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
- < 3 months since previous intensive gait training regimen
- Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
- Currently involved in another intervention study
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 |
|---|---|---|
| Ekso GT Rehabilitation TherapyAlso: ExoskeletonWalking Improvement for Spinal Cord Injuries with Exoskeleton | Device | Group 1: Ekso GT Rehabilitation Therapy |
| Body Weight Supported (BWS) Treadmill TrainingAlso: Conventional TherapyStandard gait training using BWS PT and overground training | Device | Group 2: Active controls - BWSTT Therapy |
Primary outcome
Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)
Time frame: Baseline and 12 Weeks
The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.
5 secondary outcomes
Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks
Time frame: Between baseline and 24 weeks
Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks
Time frame: Baseline-24 weeks
Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up
Time frame: Baseline and 24 weeks
Number of Participants Who Experienced a Fall During Protocol
Time frame: Throughout 24 weeks
Change in Berg Balance Scale Score From Baseline to 24 Weeks
Time frame: Baseline-24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27372363Stampacchia G, Rustici A, Bigazzi S, Gerini A, Tombini T, Mazzoleni S. Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons. NeuroRehabilitation. 2016 Jun 27;39(2):277-83. doi: 10.3233/NRE-161358.
- Background: PubMed 26736463Gad PN, Gerasimenko YP, Zdunowski S, Sayenko D, Haakana P, Turner A, Lu D, Roy RR, Edgerton VR. Iron 'ElectriRx' man: Overground stepping in an exoskeleton combined with noninvasive spinal cord stimulation after paralysis. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1124-7. doi: 10.1109/EMBC.2015.7318563.
- Background: PubMed 26364280Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12.
- Background: PubMed 24845221Kressler J, Thomas CK, Field-Fote EC, Sanchez J, Widerstrom-Noga E, Cilien DC, Gant K, Ginnety K, Gonzalez H, Martinez A, Anderson KD, Nash MS. Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury. Arch Phys Med Rehabil. 2014 Oct;95(10):1878-1887.e4. doi: 10.1016/j.apmr.2014.04.026. Epub 2014 May 17.
- Background: PubMed 26818847Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
- BackgroundKolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoTM bionic exoskeleton to aid ambulation after spinal cord injury. Spine. 2013 doi.org/10.4172/2165-7939.S4-003
- Background: PubMed 24788068Forrest GF, Hutchinson K, Lorenz DJ, Buehner JJ, Vanhiel LR, Sisto SA, Basso DM. Are the 10 meter and 6 minute walk tests redundant in patients with spinal cord injury? PLoS One. 2014 May 1;9(5):e94108. doi: 10.1371/journal.pone.0094108. eCollection 2014.
- 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.
Dylan Edwards, PhD principal investigator
Burke Medical Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ekso GT Rehabilitation Therapy and Body Weight Supported (BWS) Treadmill Training in people with Injuries, Spinal Cord, run by Ekso Bionics at 10 sites 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 16 inclusion and 28 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Yes. Results are posted in the registry (first posted 31 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) (time frame: Baseline and 12 Weeks). 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 NCT02943915, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.