StrokeNCT06478680
Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training
A study testing Exoskeleton mediated gait training and High intensity gait training in people with Stroke and Gait, Hemiplegic, run by Alvernia University at 1 site in United States.
Trial summary
The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Exoskeleton mediated gait training and High intensity gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 May 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
- 18 years of age or older
- English or Spanish-speaking
- A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
- Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic
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 ≥ 50/56 on Berg Balance Scale (BBS)
- A score of ≥ 26/30 on Functional Gait Assessment (FGA)
Show all 24Show fewer
- Resting blood pressure >180/110 mmHg
- Resting heart rate > 120 bpm
- Severe cardiac disease (New York Heart Association Classification IV)
- 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
- Pregnancy
- Colostomy
- Poor skin integrity in areas in contact with the EksoGTTM
- 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 > 3 minutes due to pain or orthostatic hypotension
- Pusher syndrome
- Cortical blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Shepherd Rehabilitation
Allentown, Pennsylvania, 18103
About this study
Official title: Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Exoskeleton mediated gait training, High intensity gait training
- Keywords
- health literacy, balance, compliance to therapy, gait function, high intensity gait training, exoskeleton
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton mediated gait trainingBehavioural
Also called EksoGT-mediated gait training
1 session of Forward Walking with EksoGT per week
1 session of conventional neurorehabilitation intervention per week
- Transfer training
- Gait training
- Balance (sitting/standing; static/dynamic)
- Strength
- Neuromuscular re-education
- Orthotics
- Positioning
- Caregiver education
- Assistive device
- Wheelchair assessment and mobility
- Endurance training
High intensity gait trainingBehavioural
2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18
- Forward stepping practice
- Backwards stepping practices
- Sidestepping
- Stairs
- Balance and compliant surface training while walking
- Propulsion
- Lateral balance training
- Stability training
- Stance control training
- Limb advancement
| Study group | Role | What they receive |
|---|---|---|
| High intensity gait training | Active comparator | One session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week Receives: Behavioral: High intensity gait training |
| Exoskeleton mediated gait training | Experimental | Two sessions of High-Intensity Gait Training Receives: Behavioral: Exoskeleton mediated gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Questionnaire
Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants.
Measured: Pre-intervention
Newest Vital Sign (NVS)
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label.
Measured: Pre-intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.
Measured: Pre-intervention
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
3-Meter Backwards Walk Test (3MBWT)
The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
6-Minute Walk Test
The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
10-meter Walk Test
The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Muscle coactivation index
Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Functional Gait Assessment (FGA)
The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment.
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Borg rating scale of Perceived Exertion
The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max).
Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Secondary outcomes (1)
Patient compliance
Patient attendance to physical therapy is tracked and will be measured as >80% attendance to physical therapy.
Measured: After 20 interventions (~10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Oct 2024
- Primary completion30 May 2025
- Study completion30 May 2025
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvernia University
- Sponsor type
- University, hospital or other
- Collaborators
- Good Shepherd Rehabilitation Network
- Responsible party
- Principal investigator, Soo Yeon Sun, PT, PhD, Alvernia University
- Investigators
- Soo Yeon Sun, PhD, Principal investigator, Alvernia UniversityKelley Limbauan, PT, DPT, NCS, Principal investigator, Good Shepherd Rehabilitation Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478680
- Sponsor's protocol ID
- 2176775-1
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
- ClinicalTrials.gov ID
- NCT06478680
- Acronym / sponsor ID
- 2176775-1
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- health literacy, balance, compliance to therapy, gait function, high intensity gait training, exoskeleton
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alvernia UniversityUniversity, hospital or other
- Collaborators
- Good Shepherd Rehabilitation Network
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Jun 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.
The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity gait training | Active comparator | Behavioral: High intensity gait trainingOne session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week |
| Exoskeleton mediated gait training | Experimental | Behavioral: Exoskeleton mediated gait trainingTwo sessions of High-Intensity Gait Training |
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 of stroke (intracerebral hemorrhage or acute ischemic stroke)
- Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic
Key exclusion criteria (24 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 ≥ 50/56 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 |
|---|---|---|
| Exoskeleton mediated gait trainingAlso: EksoGT-mediated gait training1 session of Forward Walking with EksoGT per week 1 session of conventional neurorehabilitation intervention per week * Transfer training * Gait training * Balance (sitting/standing; static/dynamic) * Strength * Neuromuscular re-education * Orthotics * Positioning * Caregiver education * Assistive device * Wheelchair assessment and mobility * Endurance training | Behavioural | Exoskeleton mediated gait training |
| High intensity gait training2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18 * Forward stepping practice * Backwards stepping practices * Sidestepping * Stairs * Balance and compliant surface training while walking * Propulsion * Lateral balance training * Stability training * Stance control training * Limb advancement | Behavioural | High intensity gait training |
Primary outcome
Demographic Questionnaire
Time frame: Pre-intervention
Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants.
Newest Vital Sign (NVS)
Time frame: Pre-intervention
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Pre-intervention
The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.
Patient Health Questionnaire (PHQ-9)
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression.
3-Meter Backwards Walk Test (3MBWT)
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented.
6-Minute Walk Test
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented.
10-meter Walk Test
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented.
Muscle coactivation index
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests.
Berg Balance Scale (BBS)
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score.
Functional Gait Assessment (FGA)
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment.
Borg rating scale of Perceived Exertion
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max).
1 secondary outcome
Patient compliance
Time frame: After 20 interventions (~10 weeks)
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, PhD principal investigator
Alvernia University
Kelley Limbauan, PT, DPT, NCS principal investigator
Good Shepherd Rehabilitation Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton mediated gait training and High intensity gait training in people with Stroke and Gait, Hemiplegic, run by Alvernia 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 4 inclusion and 24 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 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 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?
Demographic Questionnaire (time frame: Pre-intervention). The study lists 11 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.