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临床试验/NCT05859685
NCT05859685已完成不适用

Efficacy of Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients. A Randomized, Double-blind Clinical Study

Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年5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
已完成
发起方
入组人数
12
试验地点
1
主要终点
Change from baseline fear of falls after treatment and at 3 three weeks

研究概览

简要总结

The range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot.

The main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients.

Randomized, double-blind clinical trial with follow-up period. Subjects will be assigned to control and experimental groups using a data analysis tool (Excel).

The dependent variable will be the fear of falls. The secondary variables will be the range of movement in dorsiflexion of the ankle, and the functionality and stability of the lower limbs.

Three evaluations will be carried out. A baseline measurement before the start of the study (T0), after the intervention (T1) and after a 3-week follow-up period (T2).

A manual therapy protocol will be carried out, lasting 3 weeks with 1 weekly session. Each session will last 10 minutes. The patients included in the experimental group will undergo the following manual therapy techniques: talus dorsal sliding technique and joint technique in "8" on the Lisfranc and Chopart joints. The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same

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

All evaluations will be carried out by one evaluator, blinded to the study conditions and the assignment of the players to the two study groups.

The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and administration times will be the same.

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subjects older than 65 years
  • •Subjects of both sexes
  • •With impaired balance and gait
  • •With joint limitation of ankle dorsiflexion
  • •With established functionality or stability deficits (for example, who need third parties or technical aids to walk (crutches))

排除标准

  • •People with cognitive impairment that prevents their collaboration in the intervention and the different evaluations
  • •People with inability to stand
  • •People who have not given their written consent.

研究组 & 干预措施

Experimental group

Experimental

The patients included in the experimental group will undergo the following manual therapy techniques:

  • Talar dorsal sliding technique. A dorsal mobilization of the talus will be performed, with the patient in the supine position and dorsiflexion of the ankle, without pain or discomfort. The physiotherapist will exercise an anteroposterior mobilization of the talus, with a dorsal glide
  • Mulligan movement mobilization technique: The patient will be in a standing position, with the ankle to be treated forward. You will be given an aid or support in the upper extremity to maintain stability.

干预措施: Experimental (Other)

Control group

Placebo Comparator

The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same

干预措施: Control (Other)

结局指标

主要结局

Change from baseline fear of falls after treatment and at 3 three weeks

时间窗: Screening visit, within the first seven days after treatment and after three weeks follow-up

With the Short Falls Efficacy Scale-International, the confidence and ability of a person to avoid a fall while performing basic activities of daily living will be evaluated. The Spanish version of this instrument has shown high reliability (α\>0.87). It consists of 7 items with a score of 7 to 28 points (higher scores indicate less confidence and ability).

次要结局

  • Change from baseline functionality after treatment and at 3 three weeks(Screening visit, within the first seven days after treatment and after three weeks follow-up)
  • Change from baseline ankle range of motion after treatment and at 3 three weeks(Screening visit, within the first seven days after treatment and after three weeks follow-up)
  • Change from baseline biomechanical analysis of gait and balance after treatment and at 3 three weeks(Screening visit, within the first seven days after treatment and after three weeks follow-up)

研究者

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rubén Cuesta-Barriuso, PhD

Principal Investigator

Universidad Católica San Antonio de Murcia

研究点 (1)

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