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临床试验/NCT06774833
NCT06774833招募中不适用

Effect of Self-initiated Perturbation-based Balance Training on the Postural Stability of Community-dwelling Older Adults With An Increased Risk of Falling: A Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Postural stability

研究概览

简要总结

This is a single-blinded study. Participants will be randomly assigned to self-initiated perturbation-based balance training (SePBT) group or control (conventional balance training) group. Kinematic and Kinetic changes following SePBT group compared to control will be investigated.

详细描述

Participants will be randomly assigned to two groups receiving SePBT or control group. All participants will give their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenient sampling in the local community. After baseline assessment, both groups will go through two 30-minute training session over two weeks. Between-group differences in behavior will be examined before and after training to identify training-induced changes in postural stability. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Community-dwelling adults aged 60 years old or older
  • •Able to communicate effectively in Cantonese or Mandarin
  • •Able to walk independently on level ground for at least 30 minutes
  • •Abbreviated Mental Test (Hong Kong version) scores≥6
  • •Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing.

排除标准

  • •Uncorrected vision or hearing impairment
  • •Osteoporosis
  • •Have a historyof hip or knee replacement
  • •Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety
  • •Participating or planning to participate in another fall prevention program.

研究组 & 干预措施

Self-initiated perturbation-based balance training group

Experimental

This group will receive two sessions of self-initiated perturbation-based balance training.

干预措施: Self-initiated perturbation-based balance training (Behavioral)

Conventional balance training group

Active Comparator

This group will receive two sessions of balance and strength training.

干预措施: Conventional balance training (Behavioral)

结局指标

主要结局

Postural stability

时间窗: Pre-intervention, 1 week after intervention and 4 months after intervention.

Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute center of mass (CoM) position in an anteroposterior direction relative to the closest edge of the Base of Support (BoS) normalized by foot length. The absolute CoM position and BoS position will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.

次要结局

  • Generic balance ability(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Mobility(Pre-intervention, 1 week after intervention and 4 months after intervention)
  • Number of real-life falls(1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.)
  • Responsive postural adjustment upon translation(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Responsive postural adjustment upon tilting(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Dynamic balance(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Balance confidence(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Functional lower body strength(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Cognitive flexibility and executive function(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Number of laboratory falls(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Cognitive impairment(Pre-intervention.)
  • Depressive symptoms(Pre-intervention.)
  • Personality traits(Pre-intervention.)
  • Generic preference-based quality-of-life(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Muscle activations(Pre-intervention, 1 week after intervention and 4 months after intervention.)
  • Physical activity(Pre-intervention, and 4 months after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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