跳至主要内容
临床试验/NCT06844578
NCT06844578进行中(未招募)不适用

Assessment of Postural Control and Balance in the Older Adult

University of Extremadura1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Mini-Mental State Examination (MMSE)

研究概览

简要总结

A randomised clinical trial is proposed, using a probabilistic allocation design to ensure an equitable distribution of participants between the different intervention and control groups, minimising bias and increasing the internal validity of the results.

The trial foresees the voluntary participation of a total of 60 subjects, selected on the basis of previously established criteria and meeting specific characteristics criteria previously established and who meet the specific characteristics required for the study. The distribution of the participants in the clinical trial will be structured into three groups with characteristics and specific objectives, among which the following groups are highlighted:

  • Group 1 (G1) or control: This group will be composed of 20 participants who will not receive any specific intervention related to gerontogymnastics or occupational therapy programmes designed from occupational therapy.
  • Group 2 (G2) or experimental with gerontogymnastics: this group will be made up of 20 participants who will receive exclusively an intervention based on gerontogymnastics.

This programme will include a series of exercises adapted to the needs of the older adult population, with an emphasis on population, with emphasis on improving balance, muscle strength, flexibility and motor coordination.

Group 3 (G3) or experimental: will be composed of 20 participants who will receive a combined intervention. This will consist of a gerontogymnastics programme, mentioned above, merged with a specific occupational therapy plan, in which exercises such as:

  • Unipodal stability
  • Gait re-education
  • Muscle strength
  • Stationary gait

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
Single (Participant)

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

  • •Over 65 years old
  • •Residents Ntra. Sra. Del Rosario (Cáceres)
  • •Consent to participate
  • •Stable standing
  • •Tinetti <25

排除标准

  • •Does not meet inclusion criteria
  • •Medical contraindication to physical exercise
  • •Wheelchair mobility
  • •Severe cognitive impairment (>10 Minimental)

研究组 & 干预措施

Group 1 (G1) or control

No Intervention

This group will be composed of 20 participants who will not receive any spe

Group 2 (G2) or active comparator

Active Comparator

will consist of 20 participants who will receive an intervention based exclusively on gerontogymnastics.

This programme will include a series of exercises adapted to the needs of the older adult population, with emphasis on improving balance, muscle strength, flexibility and motor coordination.

motor coordination.

干预措施: Active comparator Group (Other)

Group 2 (G2) or experimental

Experimental

will consist of 20 participants who will receive a combined combined intervention. This will consist of a programme of gerontogymnastics, and a specific occupational therapy plan, in which exercises will be carried out, such as which will include exercises such as: Unipodal Stability, Gait Re-education, Muscle Strength, Stationary Gait.

干预措施: Experimental Group (Other)

结局指标

主要结局

Mini-Mental State Examination (MMSE)

时间窗: 6 weeks

The MMSE is used to assess global cognitive function, identifying possible deficits in memory, language, orientation and attention on a scale from 0 to 30, where 30 indicates global cognitive function, and 0 may indicate severe cognitive impairment.

Visual Analogue Scale (VAS)

时间窗: 6 weeks

The VAS is a tool used to measure the level of pain intensity perceived by the patient. It allows participants to rate pain on a numerical scale from 0 to 10, with 0 being no pain and 10 being the maximum intensity.

Tinetti test

时间窗: 6 weeks

The Tinetti is a tool designed to assess the risk of falls in older adults. It examines postural stability and gait, allowing the identification of balance and mobility deficits that could compromise patient safety.

Functional Independence Measure (FIM)

时间窗: 6 weeks

The FIM is used to assess a patient's functional independence in various activities of daily living (ADLs), such as grooming, mobility and communication. It is a key tool for measuring functionality-related quality of life.

Joint position sense (JPS)

时间窗: 6 weeks

Assesses lumbar proprioceptive repositioning error using the IPhone inclinometer. Degrees

Daniels Test

时间窗: 6 weeks

This test is intended to assess muscle function, specifically the gluteus maximus, quadriceps and hamstrings. It is used to determine the strength and endurance of these muscles in relation to postural stability and gait on a scale of 0 to 5, where 0 indicates no strength or inability to perform the movement and 5 indicates normal strength or optimal muscle function.

Timed Up and Go (TUG)

时间窗: 6 weeks

The TUG is an assessment method used to evaluate functional mobility and balance. It consists of measuring the time it takes for a subject to get up from a chair, walk three metres, turn around and sit down again.

Borg Scale

时间窗: 6 weeks

The Borg scale is used to measure the subjective perception of physical exertion during an activity. Participants rate their perception of fatigue as a function of exertion on a scale of 0 to 10.

次要结局

未报告次要终点

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Caña Pino

Clinical Proffesor

University of Extremadura

研究点 (1)

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