Gait, HemiplegicNCT05133362
Effects of Backward Gait Training With Exoskeleton on Motor Functions
A study testing Gait training with EksoNR and Backward gait training with EksoNR in people with Gait, Hemiplegic and Physical Therapy, run by Alvernia University at 2 sites in United States.
Trial summary
The proposed study aims to optimize patient outcomes and treatment intervention using a robotic exoskeleton in adults with cerebrovascular accidents (CVA, stroke) by investigating the following: AIM 1 is to investigate the effect of backward gait training with exoskeleton on motor function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait, Hemiplegic, Physical Therapy
- What is being tested?
- Gait training with EksoNR and Backward gait training with EksoNR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Aug 2022to 30 Sep 2024
- 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
- 18 years of age or older
- English or Spanish speaking
- A diagnosis first stroke (intracerebral hemorrhage or acute ischemic stroke)
- Referred to Reading Rehabilitation Hospital Outpatient Physical Therapy Clinic (hereafter referred to as outpatient PT)
Who cannot join
- Unable to follow 1-step commands
- > 220 pounds (100 kg)
- Height < 5'0" or > 6'4"
- Unable to take a few steps with assistance
- A score of > 42/56 on Berg Balance Scale (BBS)
- Severe cardiac disease (New York Heart Association Classification IV)
Show all 20Show fewer
- Severe spasticity (Modified Ashworth score > 3)
- Unstable spine or unhealed pelvic/limb fractures
- Active heterotrophic ossification impacting lower extremity range of motion
- Significant lower or upper extremity contractures
- Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
- Psychiatric or cognitive issues that could interfere with operating the exoskeleton
- Pregnancy
- Colostomy
- Poor skin integrity in areas in contact with the EksoNRTM
- Unresolved deep vein thrombosis
- Lower limb prosthesis or amputation
- Leg length discrepancies > 0.5 inches for upper legs, 0.75 inches for lower legs
- ROM restrictions preventing normal, reciprocal gait
- Inability to stand for > 60 seconds due to pain or orthostatic hypotension
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reading Hospital Rehabilitation at Wyomissing
Reading, Pennsylvania, 19610
Sunnyview Rehabilitation Hospital
Schenectady, New York, 12308
About this study
Official title: Investigating Effects of Backward Gait Training With Exoskeleton on Gait Function, Balance and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
The proposed study aims to optimize patient outcomes and treatment intervention using a robotic exoskeleton in adults with cerebrovascular accidents (CVA, stroke) by investigating the following: AIM 1 is to investigate the effect of backward gait training with exoskeleton on motor function.
AIM 2 is to investigate the effect of backward gait training with exoskeleton on depression.
AIM 3 is to investigate the impact of social determinants of health and depression on patient adherence to physical therapy.
Read the detailed description
Based on previous findings on backward gait training as well as the use of a wearable robotic exoskeleton in forward gait training, we hypothesize that backward gait training using exoskeleton leads to greater improvements in functional mobility, neuromuscular control and balance (AIM 1) and depression (AIM 2) in patients with stroke, when compared to standard of care, which includes forward gait training using exoskeleton. Findings from AIM 1 and 2 will provide novel evidence on the effects of backward gait training with exoskeleton in people with stroke and serve as a foundation for optimizing physical therapy protocols to improve motor functions and mental health. AIM 3 investigates the impact of social determinants of health and depression on patient adherence to physical therapy. Patient adherence (also called compliance) refers to the degree to which patients follow treatment recommendations prescribed by their health care provider.34 Even though patient adherence leads to positive treatment outcomes,35,36 it is affected by many factors, including patients' understanding of their disease and associated treatment (i.e., health literacy), social support, and depression.36-38 This experimental study employs a repeated measures design with participants randomly assigned to either a Standard Care with Ekso Group (SCG; control group, n=31) or a Standard Care with Ekso and Backward Walking Group (SCBWG; experimental group, n=31) in AIMs 1 and 2. AIMs 1 and 2 will be achieved using the group assignment as independent variables and motor function and depression as dependent variables. AIM 3 will be achieved using social determinants of health and depression as independent variables and patient adherence to physical therapy as an independent variable.
- Conditions
- Gait, Hemiplegic, Physical Therapy
- Being tested
- Gait training with EksoNR, Backward gait training with EksoNR
- Keywords
- Robotic exoskeleton, Backward gait training, Forward gait training
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with EksoNRDevice
Participants will receive forward gait training with EksoNR
Backward gait training with EksoNRProcedure or surgery
Participants will receive backward gait training with EksoNR
| Study group | Role | What they receive |
|---|---|---|
| Standard Care with Ekso Group | Active comparator | Participants in the SCG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. For each participant, an individualized plan of care consistent with evidence-based practice standards will be provided based on rehabilitation goals. The interventions during each treatment session will include forward gait training with EksoNR, neuromuscular movement-related tasks, mobility tasks, and interventions using products and technology, and education for caregivers, family, and friends. Receives: Device: Gait training with EksoNR |
| Standard Care with Ekso and Backward Walking Group | Experimental | Participants in the SCBWG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. Once a week, each participant will receive standard care as described in the standard care with Ekso group.Once a week, each participant will receive backward walking training with EksoNR during their treatment session. Receives: Device: Gait training with EksoNR; Procedure: Backward gait training with EksoNR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in backward gait speed
Changes from baseline backward gait speed measured by 3-Meter Backwards Walk Test at post-intervention
Measured: Baseline and within 1 week after the intervention
Changes in forward gait speed
Changes from baseline forward gait speed measured by 6-Minute Walk Test at post-intervention
Measured: Baseline and within 1 week after the intervention
Changes in Functional Ambulation Category
Changes from baseline ambulation ability at post-intervention. Functional Ambulation Category ranges from 0-5, and a higher score indicates a better outcome (greater independence in ambulation).
Measured: Baseline and within 1 week after the intervention
Changes in Berg Balance Scale
Changes from baseline static balance and fall risk at post-intervention. Berg Balance Scale ranges from 0 to 56, and a higher score indicates a better outcome (better balance and lower fall risk).
Measured: Baseline and within 1 week after the intervention
Changes in Patient Health Questionnaire-9
Changes from baseline depressive symptoms at post-intervention. Patient Health Questionnaire-9 ranges from 0 to 27, and a higher score indicates a worse outcome (greater depressive symptoms).
Measured: Baseline and within 1 week after the intervention
Changes in reciprocal activities in antagonistic muscles measured by Electromyography
Changes from baseline neuromuscular control of leg muscles at post-intervention. A greater reciprocity between leg antagonistic muscles indicate a better outcome.
Measured: Baseline and within 1 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start25 Aug 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, HemiplegicStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvernia University
- Sponsor type
- University, hospital or other
- Collaborators
- The Reading Hospital and Medical Center
- Responsible party
- Principal investigator, Soo Yeon Sun, PT, PhD, Alvernia University
- Investigators
- Soo Yeon Sun, Principal investigator, Alvernia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133362
- Sponsor's protocol ID
- IRB 052-21
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Effects of Backward Gait Training With Exoskeleton on Gait Function, Balance and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
- ClinicalTrials.gov ID
- NCT05133362
- Acronym / sponsor ID
- IRB 052-21
- Conditions
- Gait, Hemiplegic, Physical Therapy
- Keywords
- Robotic exoskeleton, Backward gait training, Forward gait training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alvernia UniversityUniversity, hospital or other
- Collaborators
- The Reading Hospital and Medical Center
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 24 Nov 2021 (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 proposed study aims to optimize patient outcomes and treatment intervention using a robotic exoskeleton in adults with cerebrovascular accidents (CVA, stroke) by investigating the following: AIM 1 is to investigate the effect of backward gait training with exoskeleton on motor function.
AIM 2 is to investigate the effect of backward gait training with exoskeleton on depression.
AIM 3 is to investigate the impact of social determinants of health and depression on patient adherence to physical therapy.
Detailed description
Based on previous findings on backward gait training as well as the use of a wearable robotic exoskeleton in forward gait training, we hypothesize that backward gait training using exoskeleton leads to greater improvements in functional mobility, neuromuscular control and balance (AIM 1) and depression (AIM 2) in patients with stroke, when compared to standard of care, which includes forward gait training using exoskeleton. Findings from AIM 1 and 2 will provide novel evidence on the effects of backward gait training with exoskeleton in people with stroke and serve as a foundation for optimizing physical therapy protocols to improve motor functions and mental health. AIM 3 investigates the impact of social determinants of health and depression on patient adherence to physical therapy. Patient adherence (also called compliance) refers to the degree to which patients follow treatment recommendations prescribed by their health care provider.34 Even though patient adherence leads to positive treatment outcomes,35,36 it is affected by many factors, including patients' understanding of their disease and associated treatment (i.e., health literacy), social support, and depression.36-38 This experimental study employs a repeated measures design with participants randomly assigned to either a Standard Care with Ekso Group (SCG; control group, n=31) or a Standard Care with Ekso and Backward Walking Group (SCBWG; experimental group, n=31) in AIMs 1 and 2. AIMs 1 and 2 will be achieved using the group assignment as independent variables and motor function and depression as dependent variables. AIM 3 will be achieved using social determinants of health and depression as independent variables and patient adherence to physical therapy as an independent variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care with Ekso Group | Active comparator | Device: Gait training with EksoNRParticipants in the SCG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. For each participant, an individualized plan of care consistent with evidence-based practice standards will be provided based on rehabilitation goals. The interventions during each treatment session will include forward gait training with EksoNR, neuromuscular movement-related tasks, mobility tasks, and interventions using products and technology, and education for caregivers, family, and friends. |
| Standard Care with Ekso and Backward Walking Group | Experimental | Device: Gait training with EksoNR, Procedure: Backward gait training with EksoNRParticipants in the SCBWG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. Once a week, each participant will receive standard care as described in the standard care with Ekso group.Once a week, each participant will receive backward walking training with EksoNR during their treatment session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- English or Spanish speaking
- A diagnosis first stroke (intracerebral hemorrhage or acute ischemic stroke)
- Referred to Reading Rehabilitation Hospital Outpatient Physical Therapy Clinic (hereafter referred to as outpatient PT)
Key exclusion criteria (20 listed)
- Unable to follow 1-step commands
- > 220 pounds (100 kg)
- Height < 5'0" or > 6'4"
- Unable to take a few steps with assistance
- A score of > 42/56 on Berg Balance Scale (BBS)
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 |
|---|---|---|
| Gait training with EksoNRParticipants will receive forward gait training with EksoNR | Device | Standard Care with Ekso Group, Standard Care with Ekso and Backward Walking Group |
| Backward gait training with EksoNRParticipants will receive backward gait training with EksoNR | Procedure or surgery | Standard Care with Ekso and Backward Walking Group |
Primary outcome
Changes in backward gait speed
Time frame: Baseline and within 1 week after the intervention
Changes from baseline backward gait speed measured by 3-Meter Backwards Walk Test at post-intervention
Changes in forward gait speed
Time frame: Baseline and within 1 week after the intervention
Changes from baseline forward gait speed measured by 6-Minute Walk Test at post-intervention
Changes in Functional Ambulation Category
Time frame: Baseline and within 1 week after the intervention
Changes from baseline ambulation ability at post-intervention. Functional Ambulation Category ranges from 0-5, and a higher score indicates a better outcome (greater independence in ambulation).
Changes in Berg Balance Scale
Time frame: Baseline and within 1 week after the intervention
Changes from baseline static balance and fall risk at post-intervention. Berg Balance Scale ranges from 0 to 56, and a higher score indicates a better outcome (better balance and lower fall risk).
Changes in Patient Health Questionnaire-9
Time frame: Baseline and within 1 week after the intervention
Changes from baseline depressive symptoms at post-intervention. Patient Health Questionnaire-9 ranges from 0 to 27, and a higher score indicates a worse outcome (greater depressive symptoms).
Changes in reciprocal activities in antagonistic muscles measured by Electromyography
Time frame: Baseline and within 1 week after the intervention
Changes from baseline neuromuscular control of leg muscles at post-intervention. A greater reciprocity between leg antagonistic muscles indicate a better outcome.
Results and safety
The study was stopped early (reason given: Lack of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- 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.
Soo Yeon Sun principal investigator
Alvernia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with EksoNR and Backward gait training with EksoNR in people with Gait, Hemiplegic and Physical Therapy, run by Alvernia University 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 20 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: stopped early, as of the sponsor's last update on 11 Jul 2025. 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?
The study was stopped early (reason given: Lack of participants). 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?
Changes in backward gait speed (time frame: Baseline and within 1 week after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.