The Influence of Manual Therapy Applied to the Cervical Spine (Versus Light Touch) in the Prevention of Balance Disorders in the Elderly: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change of walking speed at day 0 after 1 intervention
研究概览
简要总结
Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.
详细描述
The main hypothesis of the present study is therefore that manual therapy applied to the cervical spine may have a beneficial impact on the balance and motor performance of seniors. The study also aims to propose an assessment of the physical parameters of balance, in order to validate the contribution of the cervical spine in compensatory mechanisms.
To do so, an interventional study was designed, monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age or older, of either sex
- •Autonomous, able to walk ten meters alone without walking aid
- •Able to understand instructions necessary for the correct performance of the measurements.
排除标准
- •Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
- •Patient who has an history of surgery - fracture - dislocation of the cervical spine
- •Patient who has cognitive impairments (Mini Mental Statement <20)
- •Patient who has life expectancy less than 6 months.
研究组 & 干预措施
Sham (ligth touch)
Placebo intervention composed of light touch treatment on the cervical spine.
干预措施: Placebo intervention (Other)
Manual therapy
Manual therapy applied to the cervical spine.
干预措施: Manual therapy (Other)
结局指标
主要结局
change of walking speed at day 0 after 1 intervention
时间窗: at Day 0 before and immediately after intervention in both groups
The subject will performed a 4m gait measurement
walking speed at day 21
时间窗: at Day 21 in both groups, before the intervention for sham group
The subject will performed a 4m gait measurement
change of walking speed at day 7 after a second intervention intervention
时间窗: at Day 7 before and immediately after intervention in both groups
The subject will performed a 4m gait measurement
change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention
时间窗: at Day 0 before and immediately after intervention in both groups
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention
时间窗: at Day 7 before and immediately after intervention in both groups
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
SPPB (Short Physical Performance Battery test) score at day 21
时间窗: at Day 21 in both groups before the intervention for sham group
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
次要结局
- change in quadriceps strength at day 0 after 1 intervention(At Day 0 before and immediately after intervention in both groups)
- change in quadriceps strength at day 7 after the second intervention(At Day 7 before and immediately after intervention in both groups)
- plantar support at day 21(At Day 21 before the intervention for sham group)
- change in Heart Rate Variability at day 0 after 1 intervention(at Day 0 before and immediately after intervention in both groups)
- cervical muscle strength at day 21(at Day 21 before the intervention for sham group)
- change in static posturography at day 0 after 1 intervention(At Day 0 before and immediately after intervention in both groups)
- change in static posturography at day 7 after the second intervention(At Day 7 before and immediately after intervention in both groups)
- static posturography at day 21(At Day 21 before the intervention for sham group)
- change in plantar support at day 0 after 1 intervention(At Day 0 before and immediately after intervention in both groups)
- change in Heart Rate Variability at day 7 after the second intervention(at Day 7 before and immediately after intervention in both groups)
- change in cervical range of motion at day 7 after the second intervention(at Day 7 before and immediately after intervention in both groups)
- cervical range of motion at day 21(at Day 21 before the intervention for sham group)
- quadriceps strength at day 21(At Day 21 before the intervention for sham group)
- change in cervical range of motion at day 0 after 1 intervention(at Day 0 before and immediately after intervention in both groups)
- change in cervical muscle strength at day 0 after 1 intervention(at Day 0 before and immediately after intervention in both groups)
- change in cervical muscle strength at day 7 after the second intervention(at Day 7 before and immediately after intervention in both groups)
- Heart Rate Variability at day 21(at Day 21 before the intervention for sham group)
- change in plantar support at day 7 after the second intervention(At Day 7 before and immediately after intervention in both groups)