Long-Term Effects of Torso-Weighting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Torso Weights
* Device: Sham Weights
* Device: Fitbit Flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Torso Weights then Sham Weights<br>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. | Device: Torso Weights<br>* Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.<br>* Other names: WT;Device: Sham Weights<br>* 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.<br>* Other names: SW;Device: Fitbit Flex<br>* Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.<br>* Other names: remote activity monitoring device;|
| Experimental: Sham Weights then Torso Weights<br>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. | Device: Torso Weights<br>* Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.<br>* Other names: WT;Device: Sham Weights<br>* 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.<br>* Other names: SW;Device: Fitbit Flex<br>* Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.<br>* Other names: remote activity monitoring device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps Per Day | Continuous activity data collection via commercially-available remote monitoring device and stored on server. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change from initiation to 2-weeks after initiation of daily wearing of TW or SW | 
| Gait Velocity | As measured using instrumented gait mat. | 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. | 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. | 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. | 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. | 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. | change from initiation to 2-weeks after initiation of daily wearing of TW or SW | 
| Stride Length | As measured using instrumented gait mat. | 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. | change from initiation to 2-weeks after initiation of daily wearing of TW or SW | 
| Step Width | As measured using instrumented gait mat. | 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. | 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. | count of number of falls recorded at the end of two weeks of wearing TW or SW | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance-Based Torso-Weighting, Physical Activity, Neurorehabilitation