Multiple SclerosisTWPSNCT02743312
Long-Term Effects of Torso-Weighting
A study testing Torso Weights and Fitbit Flex in people with Multiple Sclerosis, run by San Francisco State University at 1 site in United States.
Trial summary
The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Torso Weights and Fitbit Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Self-reported a diagnosis of multiple sclerosis
- Self-reported mild or moderate gait or balance difficulties
- Living in the community rather than in a care facility
- Able to walk independently for at least one minute at a time with or without an assistive device
- No exacerbations within the past 2 months
- Able to get to the testing area and tolerate 2-3 hours of testing for each assessment occasion
- Willing to be nudged by a researcher when standing
Who cannot join
- Unable to comprehend and follow instructions in English
- Current diagnosis of other neurological disorders such as head injury, stroke, Parkinson disease, or other conditions that affect gait or balance (self-reported)
- Experiencing pain that could be exacerbated by external perturbation while standing
- History of skin reaction to adhesives
Trial locations and contacts
1 site in 1 country.
United States1 site
Samuel Merritt University, Motion Analysis Research Center
Oakland, California, 94609
About this study
Official title: Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The hypotheses of this study include: torso weighting will (1) increase physical activity, (2) decrease the number of falls, and (3) improve the timing and coordination of muscle activation during balance perturbations.
Read the detailed description
Torso weighting, using the balance-based torso-weighting (BBTW) method, is an intervention that addresses balance by first challenging stability in standing using a series of perturbations (nudges) and resisted rotations to people. Challenging stability allows the assessor to determine directional instability. Once the direction of instability is determined, small weights are placed on a vest-like garment and retesting of balance occurs. In this study, participants will be tested with no weights (NW), with sham weights (SW), and with BBTW weighting (WT). Following non-weighted baseline assessment, participants will be randomly allocated into the sham weight condition or BBTW weight condition in a cross-over design. The initial condition (NW) will last four weeks and the final two conditions (SW,WT) will last two weeks each. Following each condition, outcome measures will be reassessed. Throughout the study, participants will be asked to wear a commercially-available remote monitoring device (e.g., Fitbit Flex) and keep a daily log of physical activity and number of falls. During the SW and WT conditions, participants will wear the assigned garment for 2-4 hours daily.
- Conditions
- Multiple Sclerosis
- Being tested
- Torso Weights, Sham Weights, Fitbit Flex
- Keywords
- Balance-Based Torso-Weighting, Physical Activity, Neurorehabilitation
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torso WeightsDevice
Also called WT
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Sham WeightsDevice
Also called SW
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
Fitbit FlexDevice
Also called remote activity monitoring device
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
| Study group | Role | What they receive |
|---|---|---|
| Torso Weights then Sham Weights | Experimental | No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks.
Participants wear the Fitbit Flex throughout. Receives: Device: Torso Weights; Device: Sham Weights; Device: Fitbit Flex |
| Sham Weights then Torso Weights | Experimental | No weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks.
Participants wear the Fitbit Flex throughout. Receives: Device: Torso Weights; Device: Sham Weights; Device: Fitbit Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps Per Day
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
Measured: up to 8 weeks
Secondary outcomes (12)
Sensory Organization Test
balance tested during 6 conditions on Neuro-com forceplate and surround and reported as a composite score (across the six conditions), 0-100, with higher scores indicating better balance; measure reported reflects change in the composite score from the visit that initiates Torso-weighting (TW) or sham weights (SW) to the visit that concludes daily wearing of TW or SW
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Gait Velocity
As measured using instrumented gait mat.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
Online self-report of perceived current movement ability and preferred movement ability. The scores are reported in standardized logits, 0-6, where 6 is competitive level athletic movement. The reported values are the average change in current movement ability from initiation of daily wear to after 2 weeks of daily wear of TW or SW.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Activities-Specific Balance Confidence Scale
Self-report measure of perception of confidence under various balance challenges on a scale of 0-100 with 100 being fully confident that the individual can perform the listed balance challenge without falling. Data reported reflect the difference in scores from initiation to the 2-week point after initiation of TW or SW.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Impact Scale 29
Self-report measure of the impact of MS on activities and participation. The scale is reported in a physical and psychological subscale, with higher numbers (out of 100) indicating worse impact of multiple sclerosis (MS) on function. Data are reported as change from initiation of TW or SW to end of 2 weeks of daily wear.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Walking Scale 12
Self-report measure of the effect of MS on walking ability. Larger numbers out of 100 mean that MS limits walking much more. Data are reported as change in score from initiation of TW or SW to the visit after 2 weeks of daily wear of TW or SW.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Six-Minute Walk Test
distance participant walks in 6 minutes. Larger numbers indicate more distance covered. Data reported are the change in distance walked from initiation of TW or SW to after 2 weeks of daily wear.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Stride Length
As measured using instrumented gait mat.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Percent of Gait Cycle in Single Limb Support
As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Step Width
As measured using instrumented gait mat.
Measured: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Electromyography to Assess Muscle Activation
Recording of muscle activation during quiet and perturbed standing before and after intervention at weeks 4, 6, and 8. Average values with and without weighting during each visit.
Measured: Week 4, Week 6, Week 8
Number of Falls Recorded in 2 Weeks of Wear Time.
Daily log manually recorded by participant for the 2 weeks of wear time. This is a descriptive measure recording the total count (number) of falls per arm.
Measured: count of number of falls recorded at the end of two weeks of wearing TW or SW
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco State University
- Sponsor type
- University, hospital or other
- Collaborators
- Samuel Merritt University
- Responsible party
- Sponsor
- Investigators
- Diane Allen, PhD, Principal investigator, San Francisco State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743312
- Sponsor's protocol ID
- X15-48a
- Acronym
- TWPS
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2015
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
- ClinicalTrials.gov ID
- NCT02743312
- Acronym / sponsor ID
- TWPS / X15-48a
- Conditions
- Multiple Sclerosis
- Keywords
- Balance-Based Torso-Weighting, Physical Activity, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- San Francisco State UniversityUniversity, hospital or other
- Collaborators
- Samuel Merritt University
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 6 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The hypotheses of this study include: torso weighting will (1) increase physical activity, (2) decrease the number of falls, and (3) improve the timing and coordination of muscle activation during balance perturbations.
Detailed description
Torso weighting, using the balance-based torso-weighting (BBTW) method, is an intervention that addresses balance by first challenging stability in standing using a series of perturbations (nudges) and resisted rotations to people. Challenging stability allows the assessor to determine directional instability. Once the direction of instability is determined, small weights are placed on a vest-like garment and retesting of balance occurs. In this study, participants will be tested with no weights (NW), with sham weights (SW), and with BBTW weighting (WT). Following non-weighted baseline assessment, participants will be randomly allocated into the sham weight condition or BBTW weight condition in a cross-over design. The initial condition (NW) will last four weeks and the final two conditions (SW,WT) will last two weeks each. Following each condition, outcome measures will be reassessed. Throughout the study, participants will be asked to wear a commercially-available remote monitoring device (e.g., Fitbit Flex) and keep a daily log of physical activity and number of falls. During the SW and WT conditions, participants will wear the assigned garment for 2-4 hours daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Torso Weights then Sham Weights | Experimental | Device: Torso Weights, Device: Sham Weights, Device: Fitbit FlexNo weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout. |
| Sham Weights then Torso Weights | Experimental | Device: Torso Weights, Device: Sham Weights, Device: Fitbit FlexNo weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-reported a diagnosis of multiple sclerosis
- Self-reported mild or moderate gait or balance difficulties
- Living in the community rather than in a care facility
- Able to walk independently for at least one minute at a time with or without an assistive device
- No exacerbations within the past 2 months
Key exclusion criteria (4 listed)
- Unable to comprehend and follow instructions in English
- Current diagnosis of other neurological disorders such as head injury, stroke, Parkinson disease, or other conditions that affect gait or balance (self-reported)
- Experiencing pain that could be exacerbated by external perturbation while standing
- History of skin reaction to adhesives
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 |
|---|---|---|
| Torso WeightsAlso: WTFollowing assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. | Device | Sham Weights then Torso Weights, Torso Weights then Sham Weights |
| Sham WeightsAlso: SWFollowing assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights. | Device | Sham Weights then Torso Weights, Torso Weights then Sham Weights |
| Fitbit FlexAlso: remote activity monitoring devicePotential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device. | Device | Sham Weights then Torso Weights, Torso Weights then Sham Weights |
Primary outcome
Steps Per Day
Time frame: up to 8 weeks
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
12 secondary outcomes
Sensory Organization Test
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Gait Velocity
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Activities-Specific Balance Confidence Scale
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Impact Scale 29
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Walking Scale 12
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Six-Minute Walk Test
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Stride Length
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Percent of Gait Cycle in Single Limb Support
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Step Width
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Electromyography to Assess Muscle Activation
Time frame: Week 4, Week 6, Week 8
Number of Falls Recorded in 2 Weeks of Wear Time.
Time frame: count of number of falls recorded at the end of two weeks of wearing TW or SW
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Diane Allen, PhD principal investigator
San Francisco State 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 Torso Weights and Fitbit Flex in people with Multiple Sclerosis, run by San Francisco State 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Steps Per Day (time frame: up to 8 weeks). 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 Nov 2018.