Chronic StrokeNCT07804342
Ankle Robotics for Error Augmentation After Stroke
A study testing AMBLE in people with Chronic Stroke, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The goal of this pilot clinical trial is to test whether training with a portable ankle robot improves ankle push-off and walking speed in adults with chronic stroke who have ankle weakness. The study will also evaluate whether the device is safe and practical to use during walking rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- AMBLE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke, more than 6 months post-stroke
- Clinical evidence of hemiparetic gait
- Ankle dorsiflexion and plantarflexion strength on the affected side graded 1/5 (trace contraction) to 4/5 (reduced strength) on manual muscle testing
- Able to independently complete the 10-Meter Walk Test at a walking speed less than 1.0 m/s, with or without an assistive device
Who cannot join
- Self-reported unstable angina, myocardial infarction within the past 3 months, congestive heart failure (NYHA Class II), or hemodynamically significant valvular disease
- Self-reported hypertension that is a contraindication to routine physical therapy (greater than 160/100 mmHg on two assessments)
- Self-reported hospitalization within the past 3 months for severe medical illness
- Self-reported symptomatic peripheral arterial occlusive disease
- Self-reported orthopedic conditions or chronic pain that significantly alter gait function
- Self-reported pulmonary or renal failure
Show all 11Show fewer
- Self-reported active cancer
- Self-reported history of a non-stroke neuromuscular disorder restricting gait
- Aphasia or cognitive functioning that confounds participation, defined as unable to follow two-step commands or by judgment of the evaluating therapist
- Self-reported history of cerebellar stroke or observable cerebellar signs
- Self-reported botulinum toxin prescribed for the lower extremities within the previous 3 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Allied Health Research Building
Baltimore, Maryland, 21042
Allied Health Research Building
Baltimore, Maryland, 21201
About this study
The goal of this pilot clinical trial is to test whether training with a portable ankle robot improves ankle push-off and walking speed in adults with chronic stroke who have ankle weakness. The study will also evaluate whether the device is safe and practical to use during walking rehabilitation.
The main questions it aims to answer are:
Read more
Does training with the portable ankle robot improve paretic ankle propulsion during walking? Does training with the portable ankle robot improve walking speed at self-selected and fast walking speeds?
Participants will:
Complete 30 training sessions of treadmill and overground walking while wearing the portable ankle robot, 3 to 4 times per week over 8 to 9 weeks Complete walking and movement assessments before training, after 15 sessions, and after 30 sessions Walk at self-selected and fast speeds while researchers measure ankle propulsion, gait symmetry, and walking speed
Read the detailed description
This is a single-arm pilot study evaluating robotic error augmentation of paretic ankle propulsion during gait training in adults with chronic stroke. Ten participants with chronic (>6 months) stroke and residual ankle weakness will complete 30 training sessions using the AMBLE portable ankle exoskeleton. Assessments are conducted at baseline, after 15 sessions, and after 30 sessions. The hypothesis is that 30 sessions of robot-assisted treadmill gait training enhances paretic ankle plantarflexion propulsive torque and gait symmetry.
Approximately half of stroke survivors are left with chronic mobility disability, typically involving ankle weakness that impairs walking and increases fall risk. Current care relies on ankle-foot orthoses, functional electrical stimulation, canes, and walkers, none of which address the underlying deficit in ankle motor control. Weakness of the paretic plantarflexors limits push-off during late stance, reducing forward propulsion and contributing to reduced walking speed and gait asymmetry.
The investigators previously developed the AMBLE, a lightweight portable ankle exoskeleton that uses impedance-based control with real-time gait event detection to deliver torque synchronized to specific phases of the gait cycle. Prior work by this group using laboratory-based and portable ankle robotics targeted dorsiflexion, demonstrating reduced foot drop and improved overground walking in both early and chronic stroke, and the present study extends an ongoing investigation of the device (NCT04594837). Paretic plantarflexion propulsion has not previously been targeted with the AMBLE. Recent engineering modifications enable graded resistance during the push-off phase of gait, permitting investigation of whether error augmentation applied to paretic ankle propulsion can enhance forward propulsion during walking.
Training sessions consists of two 10-minute bouts of treadmill walking at progressively increasing speed and one 10-minute bout of overground walking as able, with the robot donned on the paretic leg. Plantarflexion resistance is delivered through the ankle robot and calibrated individually, increased as tolerated up to the level just below the point at which hip circumduction or instability emerges. Resistance is applied after attainment of steady-state walking speed and intermittently removed at predetermined intervals to sample voluntary paretic ankle power. Treadmill speed is then progressed toward a target of 70-85% heart rate reserve and RPE 15-18, recorded every 3-5 minutes. Seated rest of 2-3 minutes is provided between bouts.
Visual feedback of ankle propulsion power is delivered through a tablet-based application on a faded schedule: continuously during weeks 1-2, for 1 minute every 5 minutes during weeks 3-4, for 1 minute at the end of each 10-minute bout during weeks 5-6, and as terminal summary feedback during seated rest in weeks 7-9.
Assessments include the 10-meter walk test at self-selected and fastest comfortable speeds; overground gait biomechanics using an instrumented walkway for spatiotemporal parameters and gait symmetry and two force plates for propulsive torque during push-off; and paretic and non-paretic ankle power normalized to body mass with kinetic symmetry, collected during unassisted walking with the device in evaluation mode. The Fugl-Meyer Assessment for the Lower Extremity is administered at baseline. Baseline and post-training measures will be compared using paired t-tests or nonparametric equivalents. Findings will provide preliminary effect estimates to inform the design of a larger trial.
- Conditions
- Chronic Stroke
- Being tested
- AMBLE
- Keywords
- error augmentation, robotics, device, walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMBLEDevice
The AMBLE is a portable robotic ankle exoskeleton designed to provide individualized assistance and/or resistance during gait training. The device uses adaptive impedance-based control and real-time gait detection to provide dorsiflexion assistance during swing and plantarflexion assistance or resistance during push-off based on participant performance. It is used during treadmill and overground walking to promote recovery of ankle motor control and walking function.
| Study group | Role | What they receive |
|---|---|---|
| AMBLE Robotic Gait Training | Experimental | Participants with chronic stroke will receive a 30-session gait training program using the AMBLE portable robotic ankle exoskeleton. Training will include treadmill and overground walking with individualized robotic resistance to improve ankle plantarflexion during push-off. Robotic assistance will be adjusted throughout the intervention based on participant performance and tolerance to promote active motor recovery and improve walking function. Receives: Device: AMBLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak ankle plantarflexion propulsive torque during walking
Peak ankle plantarflexion propulsive torque will be measured using force plates during overground walking to quantify propulsion generated by the paretic limb during the push-off phase of gait.
Measured: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 sessions), and 10 weeks after intervention initiation (following approximately 30 sessions)
Secondary outcomes (3)
Self-selected walking speed
Self-selected walking speed will be assessed using the 10-Meter Walk Test and reported in meters per second.
Measured: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Fast walking speed
Maximum comfortable walking speed will be assessed using the 10-Meter Walk Test and reported in meters per second.
Measured: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Step Length Symmetry Ratio During Overground Walking Measured by Instrumented Walkway
Step length symmetry ratio computed as paretic step length divided by non-paretic step length from spatiotemporal data collected during overground walking on a GAITRite instrumented walkway. A ratio of 1.0 indicates perfect symmetry between limbs; values below 1.0 indicate shorter paretic steps and values above 1.0 indicate longer paretic steps. Values are averaged across [N] walkway passes at self-selected walking speed at each assessment timepoint. Unit of Measure: ratio
Measured: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start16 Jun 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will be assigned to a single intervention arm and receive the AMBLE robotic gait training intervention. Outcomes will be evaluated longitudinally using repeated assessments performed before, during, and after completion of the 30-session training program
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- NextStep Robotics Inc.
- Responsible party
- Principal investigator, Kelly Westlake, University of Maryland, Baltimore
- Investigators
- Kelly Westlake, PhD, PT, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804342
- Sponsor's protocol ID
- HP-00108406
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabil Neural Repair. 2011 May;25(4):369-77. doi: 10.1177/1545968310388291. Epub 2010 Nov 29.
PubMed 21115945Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.
PubMed 24515923Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.
PubMed 16151035Macko RF, Ivey FM, Forrester LW. Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. Top Stroke Rehabil. 2005 Winter;12(1):45-57. doi: 10.1310/PJQN-KAN9-TTVY-HYQH.
PubMed 15736000Westlake KP, Dudek K, Roy A, Henderson CE, Hornby TG. The Concept of Shaping Applied to Locomotor Interventions: Clinical and Robotic Strategies to Facilitate and Progress Variable Stepping Training at Higher Intensities. Neurorehabil Neural Repair. 2026 Jun 15:15459683261454948. doi: 10.1177/15459683261454948. Online ahead of print.
PubMed 42290198
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Robotics for Error Augmentation After Stroke
- ClinicalTrials.gov ID
- NCT07804342
- Acronym / sponsor ID
- HP-00108406
- Conditions
- Chronic Stroke
- Keywords
- error augmentation, robotics, device, walking
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- NextStep Robotics Inc.
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
The goal of this pilot clinical trial is to test whether training with a portable ankle robot improves ankle push-off and walking speed in adults with chronic stroke who have ankle weakness. The study will also evaluate whether the device is safe and practical to use during walking rehabilitation.
The main questions it aims to answer are:
Does training with the portable ankle robot improve paretic ankle propulsion during walking? Does training with the portable ankle robot improve walking speed at self-selected and fast walking speeds?
Participants will:
Complete 30 training sessions of treadmill and overground walking while wearing the portable ankle robot, 3 to 4 times per week over 8 to 9 weeks Complete walking and movement assessments before training, after 15 sessions, and after 30 sessions Walk at self-selected and fast speeds while researchers measure ankle propulsion, gait symmetry, and walking speed
Detailed description
This is a single-arm pilot study evaluating robotic error augmentation of paretic ankle propulsion during gait training in adults with chronic stroke. Ten participants with chronic (>6 months) stroke and residual ankle weakness will complete 30 training sessions using the AMBLE portable ankle exoskeleton. Assessments are conducted at baseline, after 15 sessions, and after 30 sessions. The hypothesis is that 30 sessions of robot-assisted treadmill gait training enhances paretic ankle plantarflexion propulsive torque and gait symmetry.
Approximately half of stroke survivors are left with chronic mobility disability, typically involving ankle weakness that impairs walking and increases fall risk. Current care relies on ankle-foot orthoses, functional electrical stimulation, canes, and walkers, none of which address the underlying deficit in ankle motor control. Weakness of the paretic plantarflexors limits push-off during late stance, reducing forward propulsion and contributing to reduced walking speed and gait asymmetry.
The investigators previously developed the AMBLE, a lightweight portable ankle exoskeleton that uses impedance-based control with real-time gait event detection to deliver torque synchronized to specific phases of the gait cycle. Prior work by this group using laboratory-based and portable ankle robotics targeted dorsiflexion, demonstrating reduced foot drop and improved overground walking in both early and chronic stroke, and the present study extends an ongoing investigation of the device (NCT04594837). Paretic plantarflexion propulsion has not previously been targeted with the AMBLE. Recent engineering modifications enable graded resistance during the push-off phase of gait, permitting investigation of whether error augmentation applied to paretic ankle propulsion can enhance forward propulsion during walking.
Training sessions consists of two 10-minute bouts of treadmill walking at progressively increasing speed and one 10-minute bout of overground walking as able, with the robot donned on the paretic leg. Plantarflexion resistance is delivered through the ankle robot and calibrated individually, increased as tolerated up to the level just below the point at which hip circumduction or instability emerges. Resistance is applied after attainment of steady-state walking speed and intermittently removed at predetermined intervals to sample voluntary paretic ankle power. Treadmill speed is then progressed toward a target of 70-85% heart rate reserve and RPE 15-18, recorded every 3-5 minutes. Seated rest of 2-3 minutes is provided between bouts.
Visual feedback of ankle propulsion power is delivered through a tablet-based application on a faded schedule: continuously during weeks 1-2, for 1 minute every 5 minutes during weeks 3-4, for 1 minute at the end of each 10-minute bout during weeks 5-6, and as terminal summary feedback during seated rest in weeks 7-9.
Assessments include the 10-meter walk test at self-selected and fastest comfortable speeds; overground gait biomechanics using an instrumented walkway for spatiotemporal parameters and gait symmetry and two force plates for propulsive torque during push-off; and paretic and non-paretic ankle power normalized to body mass with kinetic symmetry, collected during unassisted walking with the device in evaluation mode. The Fugl-Meyer Assessment for the Lower Extremity is administered at baseline. Baseline and post-training measures will be compared using paired t-tests or nonparametric equivalents. Findings will provide preliminary effect estimates to inform the design of a larger trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will be assigned to a single intervention arm and receive the AMBLE robotic gait training intervention. Outcomes will be evaluated longitudinally using repeated assessments performed before, during, and after completion of the 30-session training program
| Arm | Type | Receives |
|---|---|---|
| AMBLE Robotic Gait Training | Experimental | Device: AMBLEParticipants with chronic stroke will receive a 30-session gait training program using the AMBLE portable robotic ankle exoskeleton. Training will include treadmill and overground walking with individualized robotic resistance to improve ankle plantarflexion during push-off. Robotic assistance will be adjusted throughout the intervention based on participant performance and tolerance to promote active motor recovery and improve walking function. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke, more than 6 months post-stroke
- Clinical evidence of hemiparetic gait
- Ankle dorsiflexion and plantarflexion strength on the affected side graded 1/5 (trace contraction) to 4/5 (reduced strength) on manual muscle testing
- Able to independently complete the 10-Meter Walk Test at a walking speed less than 1.0 m/s, with or without an assistive device
Key exclusion criteria (11 listed)
- Self-reported unstable angina, myocardial infarction within the past 3 months, congestive heart failure (NYHA Class II), or hemodynamically significant valvular disease
- Self-reported hypertension that is a contraindication to routine physical therapy (greater than 160/100 mmHg on two assessments)
- Self-reported hospitalization within the past 3 months for severe medical illness
- Self-reported symptomatic peripheral arterial occlusive disease
- Self-reported orthopedic conditions or chronic pain that significantly alter gait function
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 |
|---|---|---|
| AMBLEThe AMBLE is a portable robotic ankle exoskeleton designed to provide individualized assistance and/or resistance during gait training. The device uses adaptive impedance-based control and real-time gait detection to provide dorsiflexion assistance during swing and plantarflexion assistance or resistance during push-off based on participant performance. It is used during treadmill and overground walking to promote recovery of ankle motor control and walking function. | Device | AMBLE Robotic Gait Training |
Primary outcome
Peak ankle plantarflexion propulsive torque during walking
Time frame: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 sessions), and 10 weeks after intervention initiation (following approximately 30 sessions)
Peak ankle plantarflexion propulsive torque will be measured using force plates during overground walking to quantify propulsion generated by the paretic limb during the push-off phase of gait.
3 secondary outcomes
Self-selected walking speed
Time frame: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Fast walking speed
Time frame: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Step Length Symmetry Ratio During Overground Walking Measured by Instrumented Walkway
Time frame: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 21115945Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabil Neural Repair. 2011 May;25(4):369-77. doi: 10.1177/1545968310388291. Epub 2010 Nov 29.
- Background: PubMed 24515923Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.
- Background: PubMed 16151035Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.
- Background: PubMed 15736000Macko RF, Ivey FM, Forrester LW. Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. Top Stroke Rehabil. 2005 Winter;12(1):45-57. doi: 10.1310/PJQN-KAN9-TTVY-HYQH.
- Results publication: PubMed 42290198Westlake KP, Dudek K, Roy A, Henderson CE, Hornby TG. The Concept of Shaping Applied to Locomotor Interventions: Clinical and Robotic Strategies to Facilitate and Progress Variable Stepping Training at Higher Intensities. Neurorehabil Neural Repair. 2026 Jun 15:15459683261454948. doi: 10.1177/15459683261454948. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Chronic Stroke
Not yet recruiting
Lumbar Spinal Manipulation in Stroke
Stroke
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Recruiting
Effect of Lower Limb Proprioceptive Neuromuscular Facilitation Combined With Core Stability Training Versus Proprioceptive Neuromuscular Facilitation Alone on Balance and Functional Mobility in Chronic Stroke Survivors
Stroke
Recruiting
Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Chronic Stroke
Enrolling by invitationObservational study
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
Chronic Stroke
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.
Kelly Westlake, PhD, PT principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMBLE in people with Chronic Stroke, run by University of Maryland, Baltimore at 2 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 4 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: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Peak ankle plantarflexion propulsive torque during walking (time frame: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 sessions), and 10 weeks after intervention initiation (following approximately 30 sessions)). 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 NCT07804342, which also lists 5 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 4 Sep 2026.