Multiple SclerosisMSNCT03536299
Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
A study testing Dual-task gait and Single-task gait in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Texas Woman's University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic, Cognitive Impairment
- What is being tested?
- Dual-task gait and Single-task gait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 May 2018to 31 May 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability walk independently with or without an assistive device
- Independent and community-dwelling
- No history or presence of other clinically significant musculoskeletal, cardiovascular, respiratory, or neurologic disease.
- Definite diagnosis of MS [Expanded Disability Status Scale (EDSS) ≤6.5]
- Relapse free for the past 30 days and not currently receiving or will receive any rehabilitation services during the study.
Who cannot join
- Participants experiencing a true relapse or exacerbation of their symptoms (>24 hours duration in the absence infection or fever, or and ambient increase in body temperature) during the study will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Texas Woman's University Institute of Health Sciences - Houston Center
Houston, Texas, 77030
Gregory A Brusola, PT,DPT,MSCS, 940-268-3482, gregory.brusola@memorialhermann.org
- Recruiting
TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center
Houston, Texas, 77030
Gregory A Brusola, PT,DPT,MSCS, 940-268-3482, gregory.brusola@memorialhermann.org
Marissa Lyon, PT, DPT
About this study
The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.
Read the detailed description
A total target sample size of 40 adults with MS and 40 adults without MS will be recruited. The 40 adults without MS will undergo the two baseline testing sessions only for the first phase of the study. 20 of those individuals with MS will be randomly selected to undergo the intervention phase of the study.
The research design will include two groups, the intervention and control group. Both groups will undergo a screening process, two baseline testing sessions, and be randomly assigned to one of the two groups. The duration of the study is 6 weeks in length for a total of 18 training sessions. The intervention group participants will undergo gait training with a specific concomitant cognitive task (dual-task) for a total walking time of 20 minutes and with rest breaks the total session time is ~60 minutes with a physical therapist. The control group will undergo gait training, but without the cognitive task. Feedback from the therapist will be provided to each participant concerning gait mechanics and ways to improve gait regardless of group membership.
Outcome measures data will be collected twice at baseline, once at mid-intervention, once at post-intervention, and once at one-month follow-up.
- Being tested
- Dual-task gait, Single-task gait
- Keywords
- Physical therapy, Gait training, Cognitive-motor interference, Rehabilitation
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task gaitOther
During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. In addition to performing the gait training activities, you will be asked to perform thinking tasks at the same time. These pre-recorded questions or prompts will be provided to you through headphones and a portable music player. This is to help ensure that the PT is able to focus on giving you feedback about your walking ability and answers to the thinking tasks, and on your safety. At the end of each session, you will have walked for a total walking time of 20 minutes.
Single-task gaitOther
During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. At the end of each session, you will have walked for a total walking time of 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Single-Task Gait | Active comparator | The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks. Receives: Other: Single-task gait |
| Dual-Task Gait | Experimental | The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training. Receives: Other: Dual-task gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking and Remembering Test
Measures dual-task cost of gait and a titrated forward digit span cognitive task, measured as a percentage.
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Secondary outcomes (6)
Change in 2-Minute Walk Test
Measures total distance walked by an individual within a 2-minute time period. Measures distance in feet and meters.
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Change in 12-Item Multiple Sclerosis Walking Scale
Measures self-reported and self-perceived walking disability due to MS in the past 2 weeks. The 12-Item Multiple Sclerosis Walking Scale consists of 12 questions. Each question is rated on a Likert scale from 1 (not at all) to 5 (extremely). The items are scored for a minimum score possible of 12 or a maximal score of 60. This summed score is then divided by 60 and the resulting percentage is interpreted. The scale's final percentage score can range from a minimum of 20% (minimal impact of MS on walking, good outcome) to a maximum of 100% (significant impact of MS on walking, poor outcome).
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Fatigue Scale for Motor and Cognitive Functions
Measures self-reported physical and mental fatigue levels by the patient with MS. The Fatigue Scale for Motor and Cognitive Functions measures both the motor and cognitive domains of fatigue. The scale consists of 20 total items: 10 items related to motor fatigue and 10 items related to cognitive fatigue. Each item is rated on a Likert scale from 1 (does not apply at all) to 5 (applies completely). The scale items can be summed for a total score (ranging from 20 to 100) or subscales can be summed and interpreted with each subscale ranging from a minimum of 10 points to a maximal 50 points. Higher values in the total score or in the subscale scores indicate worse fatigue and poorer quality of life due to fatigue.
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Gait Speed
Changes in gait speed (m/s) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Gait Cadence
Changes in gait cadence (steps/min) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Step Length
Changes in step length (cm) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Measured: Week 1, Week 2, Week 5, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start31 May 2018
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
- Responsible party
- Sponsor
- Investigators
- Gregory Brusola, PT,DPT,MSCS, Principal investigator, Texas Woman's University & TIRR Memorial Hermann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536299
- Sponsor's protocol ID
- 20068
- Acronym
- MS
- Status last verified
- Sep 2019
- First submitted
- 2 May 2018
- Last updated
- 18 Sep 2019
- 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 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03536299
- Acronym / sponsor ID
- MS / 20068
- Keywords
- Physical therapy, Gait training, Cognitive-motor interference, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
- Study start
- 31 May 2018 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 24 May 2018 (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 study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.
Detailed description
A total target sample size of 40 adults with MS and 40 adults without MS will be recruited. The 40 adults without MS will undergo the two baseline testing sessions only for the first phase of the study. 20 of those individuals with MS will be randomly selected to undergo the intervention phase of the study.
The research design will include two groups, the intervention and control group. Both groups will undergo a screening process, two baseline testing sessions, and be randomly assigned to one of the two groups. The duration of the study is 6 weeks in length for a total of 18 training sessions. The intervention group participants will undergo gait training with a specific concomitant cognitive task (dual-task) for a total walking time of 20 minutes and with rest breaks the total session time is ~60 minutes with a physical therapist. The control group will undergo gait training, but without the cognitive task. Feedback from the therapist will be provided to each participant concerning gait mechanics and ways to improve gait regardless of group membership.
Outcome measures data will be collected twice at baseline, once at mid-intervention, once at post-intervention, and once at one-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Task Gait | Active comparator | Other: Single-task gaitThe Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks. |
| Dual-Task Gait | Experimental | Other: Dual-task gaitThe Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability walk independently with or without an assistive device
- Independent and community-dwelling
- No history or presence of other clinically significant musculoskeletal, cardiovascular, respiratory, or neurologic disease.
- Definite diagnosis of MS [Expanded Disability Status Scale (EDSS) ≤6.5]
- Relapse free for the past 30 days and not currently receiving or will receive any rehabilitation services during the study.
Key exclusion criteria (1 listed)
- Participants experiencing a true relapse or exacerbation of their symptoms (>24 hours duration in the absence infection or fever, or and ambient increase in body temperature) during the study will be excluded from the study.
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 |
|---|---|---|
| Dual-task gaitDuring the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. In addition to performing the gait training activities, you will be asked to perform thinking tasks at the same time. These pre-recorded questions or prompts will be provided to you through headphones and a portable music player. This is to help ensure that the PT is able to focus on giving you feedback about your walking ability and answers to the thinking tasks, and on your safety. At the end of each session, you will have walked for a total walking time of 20 minutes. | Other | Dual-Task Gait |
| Single-task gaitDuring the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. At the end of each session, you will have walked for a total walking time of 20 minutes. | Other | Single-Task Gait |
Primary outcome
Change in Walking and Remembering Test
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Measures dual-task cost of gait and a titrated forward digit span cognitive task, measured as a percentage.
6 secondary outcomes
Change in 2-Minute Walk Test
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Change in 12-Item Multiple Sclerosis Walking Scale
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Fatigue Scale for Motor and Cognitive Functions
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Gait Speed
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Gait Cadence
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Change in Step Length
Time frame: Week 1, Week 2, Week 5, Week 8, Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- 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.
Gregory Brusola, PT,DPT,MSCS principal investigator
Texas Woman's University & TIRR Memorial Hermann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task gait and Single-task gait in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Texas Woman's 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 5 inclusion and 1 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 18 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory A Brusola, PT,DPT,MSCS (940-268-3482, gregory.brusola@memorialhermann.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking and Remembering Test (time frame: Week 1, Week 2, Week 5, Week 8, Week 12). 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 18 Sep 2019.