StrokeNCT06373107
Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke
A study testing High intensity gait training in people with Stroke, run by Alvernia University at 1 site in United States.
Trial summary
The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- 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 Dec 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 LVHN Outpatient Neurologic Rehab (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 ≥ 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
- 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
Lehigh Valley Health Network Outpatient Neurologic Rehab
Allentown, Pennsylvania, 18104-2310
About this study
Official title: Investigating Effects of High-intensity Gait Training 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 purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.
Read the detailed description
The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvement in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.
The findings from this study will help the researchers and clinicians decide how to help people with stroke better. Further, the findings will determine how depressive symptoms, health literacy, and other factors such as language and education affect attendance to therapy.
About 24 subjects will take part in this research.
- Conditions
- Stroke
- Being tested
- High intensity gait training
- Keywords
- High intensity gait training, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity gait trainingBehavioural
Participants will practice walking that is vigorous enough to keep their heart rate over a certain level during their physical therapy sessions. During the sessions, participants will walk and step vigorously enough to keep the heart rate between 60-80% of their maximum heart rate. Maintaining this heart rate during exercise helps to improve heart health and walking, which can affect people after a stroke.
| Study group | Role | What they receive |
|---|---|---|
| High intensity gait training | Experimental | Participants will receive 20 sessions of vigorous walking practice. These sessions are 2-3 times a week. Receives: Behavioral: High intensity gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-meter backwards walk test
Measures backward gait velocity
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
6-minute walk test
Measures aerobic capacity and endurance
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
10-meter walk test
Measures forward gait velocity
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Surface electromyography (EMG)
Electromyographical recording of 8 leg muscles () is done during forward and backward walking tests.The EMG will be recorded during 3-meter Backward Walk Test, 6-minute Walk Test, and 10-meter Walk Test in all participants
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Berg Balance Scale
a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56, with higher scores mean a better outcome.
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Functional Gait Assessment
This scale assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Scoring for each FGA item ranges from 0 for severe impairment to 3 for normal performance. The highest score possible is 30, with higher scores correlating better gait function.
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Borg Rating Scale of Perceived Exertion (RPE)
RPE is used to prescribe and monitor exercise intensity and correlates well with physiological measures of exercise intensity, including heart rate. The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 Minute Walk test. It ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." A lower score indicates a better exercise endurance.
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Patient Health Questionnaire (PHQ-9)
Depressive symptom questionnaire. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). A lower score indicates less depressive symptoms.
Measured: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Rate of patient attendance (Compliance) to physical therapy
Greater than or equal to 80% attendance to physical therapy is considered compliance to physical therapy.
Measured: Participant's attendance to physical therapy is tracked throughout the intervention sessions.
Newest Vital Sign
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy based on interpreting an ice cream nutrition label. It is available from Pfizer Pharmaceutical Company. The level of health literacy for each individual will be categorized based on the scores: a score of 0-1 suggests a high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy. This categorical variable will be used to determine the association with adherence to physical therapy.
Measured: Pre-intervention (baseline)
Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a 12-item self-administered scale that measures social support. It contains 12-items, rated on a 7-point Likert-type scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." The scale was divided into 3 subscales: family, friends, and significant other, with each section consisting of 4 items. The response scale ranges from 12 to 84. Higher scores indicate a greater family social support.
Measured: Pre-intervention (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvernia University
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh Valley Health Network
- Responsible party
- Principal investigator, Soo Yeon Sun, PT, PhD, Alvernia University
- Investigators
- Soo Yeon Sun, PhD, Principal investigator, Alvernia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373107
- Sponsor's protocol ID
- 2117651-2
- Status last verified
- Jul 2025
- First submitted
- 25 Mar 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 High-intensity Gait Training 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
- NCT06373107
- Acronym / sponsor ID
- 2117651-2
- Conditions
- Stroke
- Keywords
- High intensity gait training, Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alvernia UniversityUniversity, hospital or other
- Collaborators
- Lehigh Valley Health Network
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 18 Apr 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 study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.
Detailed description
The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvement in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.
The findings from this study will help the researchers and clinicians decide how to help people with stroke better. Further, the findings will determine how depressive symptoms, health literacy, and other factors such as language and education affect attendance to therapy.
About 24 subjects will take part in this research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High intensity gait training | Experimental | Behavioral: High intensity gait trainingParticipants will receive 20 sessions of vigorous walking practice. These sessions are 2-3 times a week. |
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 LVHN Outpatient Neurologic Rehab (hereafter referred to as outpatient PT)
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 |
|---|---|---|
| High intensity gait trainingParticipants will practice walking that is vigorous enough to keep their heart rate over a certain level during their physical therapy sessions. During the sessions, participants will walk and step vigorously enough to keep the heart rate between 60-80% of their maximum heart rate. Maintaining this heart rate during exercise helps to improve heart health and walking, which can affect people after a stroke. | Behavioural | High intensity gait training |
Primary outcome
3-meter backwards walk test
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Measures backward gait velocity
6-minute walk test
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Measures aerobic capacity and endurance
10-meter walk test
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Measures forward gait velocity
Surface electromyography (EMG)
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Electromyographical recording of 8 leg muscles () is done during forward and backward walking tests.The EMG will be recorded during 3-meter Backward Walk Test, 6-minute Walk Test, and 10-meter Walk Test in all participants
Berg Balance Scale
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56, with higher scores mean a better outcome.
Functional Gait Assessment
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
This scale assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Scoring for each FGA item ranges from 0 for severe impairment to 3 for normal performance. The highest score possible is 30, with higher scores correlating better gait function.
Borg Rating Scale of Perceived Exertion (RPE)
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
RPE is used to prescribe and monitor exercise intensity and correlates well with physiological measures of exercise intensity, including heart rate. The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 Minute Walk test. It ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." A lower score indicates a better exercise endurance.
Patient Health Questionnaire (PHQ-9)
Time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Depressive symptom questionnaire. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). A lower score indicates less depressive symptoms.
Rate of patient attendance (Compliance) to physical therapy
Time frame: Participant's attendance to physical therapy is tracked throughout the intervention sessions.
Greater than or equal to 80% attendance to physical therapy is considered compliance to physical therapy.
Newest Vital Sign
Time frame: Pre-intervention (baseline)
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy based on interpreting an ice cream nutrition label. It is available from Pfizer Pharmaceutical Company. The level of health literacy for each individual will be categorized based on the scores: a score of 0-1 suggests a high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy. This categorical variable will be used to determine the association with adherence to physical therapy.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Pre-intervention (baseline)
The MSPSS is a 12-item self-administered scale that measures social support. It contains 12-items, rated on a 7-point Likert-type scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." The scale was divided into 3 subscales: family, friends, and significant other, with each section consisting of 4 items. The response scale ranges from 12 to 84. Higher scores indicate a greater family social support.
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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity gait training in people with Stroke, 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?
3-meter backwards walk test (time frame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of 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.