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临床试验/CTRI/2024/11/077479
CTRI/2024/11/077479
尚未招募
不适用

Assessment of improvement of balance after implementing fall prevention techniques in patients with osteoporosis

Dr Laiphrakpam Ishwarlal Singh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月7日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Laiphrakpam Ishwarlal Singh
入组人数
100
试验地点
1
主要终点
Parameters which are taken from Balance analyser that will measure and assess the balance improvement in patients are:Sway Index % difference (overall) in bilateral comparison test,Stability index (overall) in postural stability test,Composite score- average in CTSIB test (Clinical Test of Sensory Integration of Balance),Sway Velocity Index (SVI) Composite Score in fall risk test .

概览

简要总结

Balance deficits significantly contribute to the risk of falls and subsequent fractures, which can lead to severe morbidity, decreased quality of life, and increased healthcare costs. The primary objective of this study is to evaluate the impact of fall prevention techniques specifically balance training and strengthening exercises on balance improvement in patients diagnosed with osteoporosis. The use of a Balance analyser provides a thorough and impartial evaluation of balance management. These analysers offer quantitative information on various characteristics, including sway index, stability index, composite score-average in CTSIB, and postural sway velocity allowing for an accurate assessment of balance status and advancement over time. Precise and extensive information can be gathered regarding balance outcomes by including balance analyser measures in the assessment, resulting in a more thorough and impartial evaluation of the interventional effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Participants must have a primary osteoporosis diagnosis based on recognised diagnostic standards, such as clinical evaluations or measures of bone mineral density (on DEXA, BMD – T score less than or equal to -2.5, WHO classification).
  • Participants should be physically and mentally capable of taking part in the balancing tests and fall prevention strategies.
  • This could be evaluated via a screening procedure or medical assessment.

排除标准

  • People with serious neurological illnesses that could influence balance.
  • People who have recently suffered fractures that might make it difficult for them to participate in interventions or assessments.
  • People with severe comorbidities who would make it difficult for them to take part in the study or comprehend the results.
  • Cases of secondary osteoporosis.
  • Participants with any conditions that make using the Balance Analyser or engaging in fall prevention strategies unsafe.
  • Those who planned to be out of town for more than 4 weeks during study.

结局指标

主要结局

Parameters which are taken from Balance analyser that will measure and assess the balance improvement in patients are:Sway Index % difference (overall) in bilateral comparison test,Stability index (overall) in postural stability test,Composite score- average in CTSIB test (Clinical Test of Sensory Integration of Balance),Sway Velocity Index (SVI) Composite Score in fall risk test .

时间窗: At baseline, 2 weeks,4 weeks and 12 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Laiphrakpam Ishwarlal Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Laiphrakpam Ishwarlal Singh

IPGMER and SSKM Hospital

研究点 (1)

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