Ambulation DifficultyNCT06548087
Use Of Gigstride Device In Patients With Lower Extremity Deficit
A study testing Gigstride Ambulatory Device in people with Ambulation Difficulty and Lower Extremity Problem, run by Johns Hopkins University at 1 site in United States.
Trial summary
For patients with lower extremity deficits, the investigator(s) would like to assess implementing use of Gigstride ambulatory device to assess the following: Patient satisfaction with use of ambulatory device Effects of Gigstride device utilization on kinetics, biomechanics Effects of Gigstride device utilization on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulation Difficulty, Lower Extremity Problem
- What is being tested?
- Gigstride Ambulatory Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 6 Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age > 18
- Has undergone treatment for a lower extremity mobility deficit, with one of the following causatives Principal Diagnoses Osteoarthritis hip, knee, spine Pre or post hip replacement Pre or post knee replacement Multiple Sclerosis Mild to moderate central spinal stenosis Foot drop Degenerative changes, not otherwise specified Balance issues
- Recommended cane, brace, walker, Ankle Foot Orthoses, or electronic or robotic device for management
- Provide written consent for participation.
- Ability to wear shoes with laces
Who cannot join
- Inability to walk.
- Shoulder operation within 1 year preceding the study date.
- Injury due to a work accident (e.g. workers comp)
- Higher functions do not enable proper comprehension of protocol or reliable data recording.
Trial locations and contacts
1 site in 1 country.
About this study
For patients with lower extremity deficits, the investigator(s) would like to assess implementing use of Gigstride ambulatory device to assess the following:
- Patient satisfaction with use of ambulatory device
- Effects of Gigstride device utilization on kinetics, biomechanics
- Effects of Gigstride device utilization on walking speed, stair speed, stability
Read the detailed description
The Gigstride ambulatory device is a novel product that can possibly be used as an alternative ambulatory aid.
- The Gigstride Wearable trainer is a flexible device anchored at distal points in the body. Reciprocating elastic cords follow a path through engineered guides that surround and engage the core, enhance hip and knee flexion, and improve balance. It uses the body's own structure to create symmetry, each step creates momentum and lift, users report feeling lighter, stronger, straighter, and more stable. The gentle, adjustable pressure provides alignment and proprioceptive input that allows for neuromuscular re-education.
- The cords can be configured to target specific therapeutic goals. The two larger diameter cords are used for hip and knee flexion, attaching to the medial and lateral aspect of the shoe at an eyelet near the malleolus. The two smaller diameter cords are used for Foot Drop and attach to the medial and lateral eyelets at the distal part of the shoe, supporting dorsiflexion. In-toeing and out-toeing can be mitigated by attaching both cords either medially or laterally to gently align the foot.
- The Gigstride wearable is a working prototype that can be fitted to almost anyone.
This research is being done to investigate the effectiveness of the Gigstride ambulatory device among individuals who have undergone prior treatment for a lower extremity mobility deficit, with one of the following causatives "Principal Diagnoses": Osteoarthritis hip, knee, spine, Pre or post hip replacement, Pre or post knee replacement, Multiple Sclerosis, Mild to moderate central spinal stenosis, Foot drop, Degenerative changes, not otherwise specified, Balance issues. The patient would have to be seen by physical therapy and recommended cane, brace, walker, Ankle Foot Orthoses, or electronic or robotic device for management.
For patients who are scheduled to be seen by the investigator in clinic with one of the above diagnoses, and recommended to use some type of ambulatory aid, the investigator will offer the Gigstride ambulatory device as an alternative and inquire about the patient's interest in participating in the study. After choosing to be a part of the study, the patients will use Gigstride device to perform the following tasks:
- Walk a different distances to assess speed and fatigue
- Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.)
The participants will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device.
The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour.
- Conditions
- Ambulation Difficulty, Lower Extremity Problem
- Being tested
- Gigstride Ambulatory Device
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gigstride Ambulatory DeviceDevice
For patients who are scheduled to be seen by the investigator in clinic with one of the above diagnoses, and recommended to use some type of ambulatory aid, the investigator will offer the Gigstride ambulatory device as an alternative and inquire about the patient's interest in participating in the study. After choosing to be a part of the study, the participant will use Gigstride device to perform the following tasks:
- Walk a different distances to assess speed and fatigue
- Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.)
The participant will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device.
The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Use of Gigstride Ambulatory Device | Experimental | The participant will be use the Gigstride ambulatory device to perform the following tasks:
* Walk a different distances to assess speed and fatigue
* Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.)
The participants will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device.
The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour. Receives: Device: Gigstride Ambulatory Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Feasibility as assessed by ambulatory device aid score
The investigators will assess the participants comfort and ease of use of the proposed device with a questionnaire that consists of 11 questions in a likert scale. 1 = strongly agree to 5 = strongly disagree. Lowest score of 11 = participant agrees that the device is a feasible option as an ambulatory aid. Highest score of 55 = participants disagree that the proposed device can be used as an ambulatory aid.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start8 Oct 2024
- Primary completion26 Aug 2025
- Study completion6 Nov 2025
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 Ambulation DifficultyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Gigstride Corporation
- Responsible party
- Sponsor
- Investigators
- Akhil Chhatre, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548087
- Sponsor's protocol ID
- IRB00406374
- Status last verified
- Nov 2025
- First submitted
- 7 Aug 2024
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual results will not be shared. Only the overall results from all participants.
Publications
Khawer A, Dang J, Rojas-Cardenas A, Khokhar D, Jain A, Goodwin BJ, Crane J, Crimmins M, Muneio E, Chhatre A. Evaluation of the Gigstride wearable device for pain reduction and functional outcomes in patients with lower extremity mobility deficits: a single-arm pilot feasibility study. Pain Manag. 2026 Jul;16(7):789-797. doi: 10.1080/17581869.2026.2664763. Epub 2026 May 7.
PubMed 42095624
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Gigstride Device In Patients With Lower Extremity Deficit
- ClinicalTrials.gov ID
- NCT06548087
- Acronym / sponsor ID
- IRB00406374
- Conditions
- Ambulation Difficulty, Lower Extremity Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gigstride Corporation
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 12 Aug 2024 (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.
For patients with lower extremity deficits, the investigator(s) would like to assess implementing use of Gigstride ambulatory device to assess the following:
- Patient satisfaction with use of ambulatory device
- Effects of Gigstride device utilization on kinetics, biomechanics
- Effects of Gigstride device utilization on walking speed, stair speed, stability
Detailed description
The Gigstride ambulatory device is a novel product that can possibly be used as an alternative ambulatory aid.
- The Gigstride Wearable trainer is a flexible device anchored at distal points in the body. Reciprocating elastic cords follow a path through engineered guides that surround and engage the core, enhance hip and knee flexion, and improve balance. It uses the body's own structure to create symmetry, each step creates momentum and lift, users report feeling lighter, stronger, straighter, and more stable. The gentle, adjustable pressure provides alignment and proprioceptive input that allows for neuromuscular re-education.
- The cords can be configured to target specific therapeutic goals. The two larger diameter cords are used for hip and knee flexion, attaching to the medial and lateral aspect of the shoe at an eyelet near the malleolus. The two smaller diameter cords are used for Foot Drop and attach to the medial and lateral eyelets at the distal part of the shoe, supporting dorsiflexion. In-toeing and out-toeing can be mitigated by attaching both cords either medially or laterally to gently align the foot.
- The Gigstride wearable is a working prototype that can be fitted to almost anyone.
This research is being done to investigate the effectiveness of the Gigstride ambulatory device among individuals who have undergone prior treatment for a lower extremity mobility deficit, with one of the following causatives "Principal Diagnoses": Osteoarthritis hip, knee, spine, Pre or post hip replacement, Pre or post knee replacement, Multiple Sclerosis, Mild to moderate central spinal stenosis, Foot drop, Degenerative changes, not otherwise specified, Balance issues. The patient would have to be seen by physical therapy and recommended cane, brace, walker, Ankle Foot Orthoses, or electronic or robotic device for management.
For patients who are scheduled to be seen by the investigator in clinic with one of the above diagnoses, and recommended to use some type of ambulatory aid, the investigator will offer the Gigstride ambulatory device as an alternative and inquire about the patient's interest in participating in the study. After choosing to be a part of the study, the patients will use Gigstride device to perform the following tasks:
- Walk a different distances to assess speed and fatigue
- Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.)
The participants will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device.
The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Gigstride Ambulatory Device | Experimental | Device: Gigstride Ambulatory DeviceThe participant will be use the Gigstride ambulatory device to perform the following tasks: * Walk a different distances to assess speed and fatigue * Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.) The participants will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device. The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age > 18
- Has undergone treatment for a lower extremity mobility deficit, with one of the following causatives Principal Diagnoses Osteoarthritis hip, knee, spine Pre or post hip replacement Pre or post knee replacement Multiple Sclerosis Mild to moderate central spinal stenosis Foot drop Degenerative changes, not otherwise specified Balance issues
- Recommended cane, brace, walker, Ankle Foot Orthoses, or electronic or robotic device for management
- Provide written consent for participation.
- Ability to wear shoes with laces
Key exclusion criteria (4 listed)
- Inability to walk.
- Shoulder operation within 1 year preceding the study date.
- Injury due to a work accident (e.g. workers comp)
- Higher functions do not enable proper comprehension of protocol or reliable data recording.
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 |
|---|---|---|
| Gigstride Ambulatory DeviceFor patients who are scheduled to be seen by the investigator in clinic with one of the above diagnoses, and recommended to use some type of ambulatory aid, the investigator will offer the Gigstride ambulatory device as an alternative and inquire about the patient's interest in participating in the study. After choosing to be a part of the study, the participant will use Gigstride device to perform the following tasks: * Walk a different distances to assess speed and fatigue * Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.) The participant will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device. The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour. | Device | Use of Gigstride Ambulatory Device |
Primary outcome
Device Feasibility as assessed by ambulatory device aid score
Time frame: 1 year
The investigators will assess the participants comfort and ease of use of the proposed device with a questionnaire that consists of 11 questions in a likert scale. 1 = strongly agree to 5 = strongly disagree. Lowest score of 11 = participant agrees that the device is a feasible option as an ambulatory aid. Highest score of 55 = participants disagree that the proposed device can be used as an ambulatory aid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Derived from this study: PubMed 42095624Khawer A, Dang J, Rojas-Cardenas A, Khokhar D, Jain A, Goodwin BJ, Crane J, Crimmins M, Muneio E, Chhatre A. Evaluation of the Gigstride wearable device for pain reduction and functional outcomes in patients with lower extremity mobility deficits: a single-arm pilot feasibility study. Pain Manag. 2026 Jul;16(7):789-797. doi: 10.1080/17581869.2026.2664763. Epub 2026 May 7.
- Individual participant dataSharing planned: No. No, individual results will not be shared. Only the overall results from all participants.
Related trials for Ambulation Difficulty
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Active, not recruiting
Randomized Clinical Trial to Improve Mobility After Hospitalization
Hypertension, Diabetes
Active, not recruiting
Testing Interventions for Mobility Through Exercise (TIME)
Walking, Difficulty, Mobility Limitation
Not yet recruiting
Impact of Loss Aversion Messaging and Anticipated Regret for Inaction on Exercise Adherence in Older Adults
Mobility Disability, Walking Difficulty
RecruitingPhase 2
Response to Exercise and Nitric Oxide in PAD
Peripheral Artery Disease, Exercise
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.
Akhil Chhatre, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gigstride Ambulatory Device in people with Ambulation Difficulty and Lower Extremity Problem, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Feasibility as assessed by ambulatory device aid score (time frame: 1 year). 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 NCT06548087, 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 6 Nov 2025.