Multiple SclerosisNCT02759211
Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
A study testing Backwards Walking and Forwards Walking in people with Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital at 1 site in United States.
Trial summary
There have been no published studies to date on the effects of backwards walking in persons with MS. Thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with MS with gait disturbances and balance impairments.The overall goal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Backwards Walking and Forwards Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Feb 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed clinical diagnosis of MS
- Cognitively able to understand directions and complete protocol (score of 22 or greater on MMSE)
- Signed Consent form approved by the Saint Francis Institutional Review Board
- 18-65 years of age
- PDDS score of 3 to 5 during the past 12 months
- Completion of the 6 minute walk test
- Speaks English (in order to safely complete intervention)
Who cannot join
- Unwilling or unable to complete assessments and intervention
- Current participation in physical therapy
- Major changes in exercise habits in the past three months
- Has had a relapse, acute Solumedrol treatment, or Acthar treatment in the past two months
- Requires constant bilateral assistance (canes or crutches) for ambulation and/or cannot walk at least 100 meters without resting
- Current self-reported medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of DVT, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes [11]
- Participants that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
Jennifer Ruiz, DPT, 860-714-2149
About this study
There have been no published studies to date on the effects of backwards walking in persons with MS. Thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with MS with gait disturbances and balance impairments.The overall goal of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward walking.
- Conditions
- Multiple Sclerosis
- Being tested
- Backwards Walking, Forwards Walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backwards WalkingOther
The Backwards Walking Group will perform backwards walking for the entire treatment intervention.
Forwards WalkingOther
The Forwards Walking Group will perform forwards walking for the entire treatment intervention.
| Study group | Role | What they receive |
|---|---|---|
| Forwards Walking Group (FWG) | Active comparator | The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions. Receives: Other: Forwards Walking |
| Backwards Walking Group (BWG) | Experimental | The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions. Receives: Other: Backwards Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal Walking Parameters from Gaitrite Mat
Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Measured: Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Gait Speed (Timed 25 Foot Walk)
Timed 25 Foot Walk
Measured: Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention
Single Leg Stance (SLS)
Measured: Change in Baseline SLS after 8 week intervention
Secondary outcomes (2)
Timed-up and Go
Measured: Change in Baseline TUG after 8 week intervention
Activities-Specific Balance Confidence Scale (ABC)
Measured: Change in Baseline ABC after 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (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
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759211
- Sponsor's protocol ID
- SFH-16-27
- Status last verified
- Aug 2017
- First submitted
- 22 Mar 2016
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02759211
- Acronym / sponsor ID
- SFH-16-27
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mount Sinai Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Apr 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 3 May 2016 (estimated)
- 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.
There have been no published studies to date on the effects of backwards walking in persons with MS. Thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with MS with gait disturbances and balance impairments.The overall goal of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forwards Walking Group (FWG) | Active comparator | Other: Forwards WalkingThe intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions. |
| Backwards Walking Group (BWG) | Experimental | Other: Backwards WalkingThe intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed clinical diagnosis of MS
- Cognitively able to understand directions and complete protocol (score of 22 or greater on MMSE)
- Signed Consent form approved by the Saint Francis Institutional Review Board
- 18-65 years of age
- PDDS score of 3 to 5 during the past 12 months
Key exclusion criteria (7 listed)
- Unwilling or unable to complete assessments and intervention
- Current participation in physical therapy
- Major changes in exercise habits in the past three months
- Has had a relapse, acute Solumedrol treatment, or Acthar treatment in the past two months
- Requires constant bilateral assistance (canes or crutches) for ambulation and/or cannot walk at least 100 meters without resting
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 |
|---|---|---|
| Backwards WalkingThe Backwards Walking Group will perform backwards walking for the entire treatment intervention. | Other | Backwards Walking Group (BWG) |
| Forwards WalkingThe Forwards Walking Group will perform forwards walking for the entire treatment intervention. | Other | Forwards Walking Group (FWG) |
Primary outcome
Spatiotemporal Walking Parameters from Gaitrite Mat
Time frame: Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Gait Speed (Timed 25 Foot Walk)
Time frame: Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention
Timed 25 Foot Walk
Single Leg Stance (SLS)
Time frame: Change in Baseline SLS after 8 week intervention
2 secondary outcomes
Timed-up and Go
Time frame: Change in Baseline TUG after 8 week intervention
Activities-Specific Balance Confidence Scale (ABC)
Time frame: Change in Baseline ABC after 8 week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- 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.
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
Hartford, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backwards Walking and Forwards Walking in people with Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital 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 7 inclusion and 7 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 30 Aug 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatiotemporal Walking Parameters from Gaitrite Mat (time frame: Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention). The study lists 3 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 30 Aug 2017.