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临床试验/NCT04626934
NCT04626934招募中不适用

Can Specific Cognitive Intervention With Post-Acute Cognitively Impaired Hip Fracture Patients Improve Rehabilitation Outcome

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
The Montebello Rehabilitation Factor Score (MRFS)

研究概览

简要总结

The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.

详细描述

Hip fracture often occurs in frail older people and is a major concern for the health care systems because it is associated with an up to 36% excess mortality within 1 year. Hip fracture also represents a risk factor for further falls and fractures, functional decline and institutionalization, with <40% of hip fractured patients regaining their pre-injury level of ambulation.

One of the most challenging tasks of today's post-acute geriatric rehabilitation wards is improving the functional abilities of fragile hip-fractured patients and discharging most of them to their homes. Yet, the rising incidence of hip fractures in the elderly has created an overwhelming workload on those departments and has significantly increased the burden on healthcare resources. Previous studies have found that cognitive decline is an important negative predictor in rehabilitation. Several studies have shown that cognitive interventions can improve functional abilities of older people. Yet, these studies were conducted in community dwelling older people. Our study will assess this issue amongst post-acute rehabilitation hip fracture patients. Our hypotyhesis is that those patients recieving specific cognitive intervention will show significantly better rehabilitation outcomes and cognitive function.

The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.

This is a randomized double blinded study. We will compare two groups: one will recieve specific cognitive intervention and a control group will recieve conventional occupational therapy treatment. Both groups will recieve the same amount of interventions.The interventions will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing.

Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The patients and the team that assess the patients do not know to which group the patients have been assigned

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All concecutive hip fracture patients admitted to a post-acute rehabilitation ward Mini mental state examination above 17 Lived at home before the fracture and did not recieved 24 hour home aid

排除标准

  • Patients who will not complete rehabilitation program due to worsening of their medical condition or unexpectedly cease rehabilitation will be omitted from the statistical analyses.

结局指标

主要结局

The Montebello Rehabilitation Factor Score (MRFS)

时间窗: The score will be calculated at discharge, assessed up to 3 months from randomization.

The MRFS achieved on the mFIM score is calculated by the Montebello Rehabilitation Factor Score (MRFS), designed to overcome the floor and ceiling effect problem and calculate each patient's specific potential for improvement. The MRFS also known as mFIM effectiveness, will be calculated as the mFIM score change (discharge mFIM score-admission mFIM score) divided by the mFIM maximum score (91) minus the mFIM admission score.

motor Functional Independence Measure (mFIM)

时间窗: The change in the measure from randomization until the date of discharge, assessed up 3 months.

The motor FIM (mFIM) includes 13 parameters of ADL and mobility. maximal total score for the mFIM is 91. The patient's motor FIM score was assessed during multi-disciplinary team meeting

Functional Independence Measure (FIM)

时间窗: The change in the measure from randomization until the date of discharge, assessed up 3 months.

The FIM is a disability measure, administered on admission and upon discharge to assess change in functional abilities. The FIM comprises 18 parameters, each rated on a scale of 1 to 7 according to the degree of assistance required to perform a specific activity in 3 domains: activities of daily living (ADL) (8 parameters), mobility level (5 parameters) and cognitive function (5 parameters). The maximal total score for the FIM is 126. The patient's FIM score will be assessed during multi-disciplinary team meeting

次要结局

  • Color Trail Test(The change in the measure from admission and upon completion of the intervention protocol (3 weeks).)
  • Kettle Test(The change in the measure from admission and upon completion of the intervention protocol (3 weeks).)
  • Montreal Cognitive Assessement (MOCA)(The change in the measure from admission and upon completion of the intervention protocol (3 weeks).)
  • Groningen Activity Restriction Scale(The change in the measure from admission and upon completion of the intervention protocol (3 weeks).)
  • EQ-5D (EuroQol Group)(The change in the measure from admission and upon completion of the intervention protocol (3 weeks).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AVITAL HERSHKOVITZ

Head, Geriatric Rehabilitation Ward

Rabin Medical Center

研究点 (1)

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