Multiple SclerosisNCT05560880
High Intensity Interval Gait Training in Multiple Sclerosis
A study testing High Intensity Interval Gait training and Moderate Intensity Interval gait training in people with Multiple Sclerosis, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High Intensity Interval Gait training and Moderate Intensity Interval gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons diagnosed with Multiple Sclerosis.
- The ability to walk for 6 minutes continuously with or without assistive device.
- The ability to read, understand and sign a consent form so that they are able to understand the study we are doing
- Above the age of 18
Who cannot join
- Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions
- Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hunter College
New York, New York, 11238
Herb Karpatkin, DSc, 212-396-7115, hkarpatk@hunter.cuny.edu
About this study
Official title: The Effects of High Intensity Interval Gait Training vs. Moderate Intensity Continuous Gait Training in Multiple Sclerosis
Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.
Read the detailed description
Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.
Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?
Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.
Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS. HIIGT has been shown to be effective in persons with stroke but the effects of HIIGT on pwMS are not known.
Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.
- Conditions
- Multiple Sclerosis
- Being tested
- High Intensity Interval Gait training, Moderate Intensity Interval gait training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Gait trainingBehavioural
Subjects will walk as fast as they can for 30 seconds, followed by a 60 second seated recovery. They will be guarded by a physical therapist at all times.
Moderate Intensity Interval gait trainingBehavioural
subjects will walk for 20 minutes at theri best comfortable pace
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval gait training | Experimental | subjects will receive 3x/week high intensity interval training for 20 minutes over a 4 week period Receives: Behavioral: High Intensity Interval Gait training |
| Moderate intensity continuous gait training | Active comparator | subjects will receive 3x/week moderate intensity continuous gait training for 20 minutes over a 4 week period Receives: Behavioral: Moderate Intensity Interval gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six minute walk test time from before to after the intervention
Subjects will walk for six minutes at their best comfortable pace. They will be guarded by physical therapist for the entire walk. Total distance, distance per minute, and heart rate will be measured.
Measured: The test will be administered to all subjects one week before and one week after the intervention.The test will be administered to all subjects one week before and one week after the intervention.
Secondary outcomes (3)
Change in Functional gait assessment score from before to after the intervention
Used to assess balance during different walking conditions
Measured: Will be done in the week before and the week after the intervention.Will be done in the week before and the week after the intervention.
Change in Hand held dynamometry values from before to after the intervention
Use of the strain gauge to determine lower extremity muscle strength
Measured: Will be done the week before and the week after the intervention.
Change in Multiple sclerosis impact scale 29 from before to afterthe intervention
Quality of life measure where are the subject subjectively rates the impact of multiple sclerosis on their life
Measured: Performed in the week before and the 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 posted30 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert Karpatkin, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560880
- Sponsor's protocol ID
- 2022-0261
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 6 Oct 2022
- 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 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High Intensity Interval Gait Training vs. Moderate Intensity Continuous Gait Training in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05560880
- Acronym / sponsor ID
- 2022-0261
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Sep 2022 (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.
Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.
Detailed description
Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.
Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?
Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.
Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS. HIIGT has been shown to be effective in persons with stroke but the effects of HIIGT on pwMS are not known.
Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval gait training | Experimental | Behavioral: High Intensity Interval Gait trainingsubjects will receive 3x/week high intensity interval training for 20 minutes over a 4 week period |
| Moderate intensity continuous gait training | Active comparator | Behavioral: Moderate Intensity Interval gait trainingsubjects will receive 3x/week moderate intensity continuous gait training for 20 minutes over a 4 week period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons diagnosed with Multiple Sclerosis.
- The ability to walk for 6 minutes continuously with or without assistive device.
- The ability to read, understand and sign a consent form so that they are able to understand the study we are doing
- Above the age of 18
Key exclusion criteria (2 listed)
- Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions
- Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables
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 Interval Gait trainingSubjects will walk as fast as they can for 30 seconds, followed by a 60 second seated recovery. They will be guarded by a physical therapist at all times. | Behavioural | High Intensity Interval gait training |
| Moderate Intensity Interval gait trainingsubjects will walk for 20 minutes at theri best comfortable pace | Behavioural | Moderate intensity continuous gait training |
Primary outcome
Change in Six minute walk test time from before to after the intervention
Time frame: The test will be administered to all subjects one week before and one week after the intervention.The test will be administered to all subjects one week before and one week after the intervention.
Subjects will walk for six minutes at their best comfortable pace. They will be guarded by physical therapist for the entire walk. Total distance, distance per minute, and heart rate will be measured.
3 secondary outcomes
Change in Functional gait assessment score from before to after the intervention
Time frame: Will be done in the week before and the week after the intervention.Will be done in the week before and the week after the intervention.
Change in Hand held dynamometry values from before to after the intervention
Time frame: Will be done the week before and the week after the intervention.
Change in Multiple sclerosis impact scale 29 from before to afterthe intervention
Time frame: Performed in the week before and the week after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- 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.
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 Interval Gait training and Moderate Intensity Interval gait training in people with Multiple Sclerosis, run by Hunter College of City University of New York 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 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herb Karpatkin, DSc (212-396-7115, hkarpatk@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Six minute walk test time from before to after the intervention (time frame: The test will be administered to all subjects one week before and one week after the intervention.The test will be administered to all subjects one week before and one week after the intervention.). 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 6 Oct 2022.