Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Steps Per Day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Torso Weights then Sham Weights
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.
干预措施: Torso Weights (Device)
Torso Weights then Sham Weights
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.
干预措施: Sham Weights (Device)
Torso Weights then Sham Weights
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.
干预措施: Fitbit Flex (Device)
Sham Weights then Torso Weights
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.
干预措施: Torso Weights (Device)
Sham Weights then Torso Weights
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.
干预措施: Sham Weights (Device)
Sham Weights then Torso Weights
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.
干预措施: Fitbit Flex (Device)
结局指标
主要结局
Steps Per Day
时间窗: up to 8 weeks
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
次要结局
- Sensory Organization Test(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Stride Length(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Number of Falls Recorded in 2 Weeks of Wear Time.(count of number of falls recorded at the end of two weeks of wearing TW or SW)
- Activities-Specific Balance Confidence Scale(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Multiple Sclerosis Walking Scale 12(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Electromyography to Assess Muscle Activation(Week 4, Week 6, Week 8)
- Step Width(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Six-Minute Walk Test(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Gait Velocity(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Multiple Sclerosis Impact Scale 29(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)
- Percent of Gait Cycle in Single Limb Support(change from initiation to 2-weeks after initiation of daily wearing of TW or SW)