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Completed

NCT Number: NCT05859685

Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients

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

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Key information

Conditions

Old Age; Atrophy Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio de Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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))

Exclusion criteria

  • 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.

Treatment and study plan

Experimental

Other

Manual therapy techniques:

  • Talar dorsal sliding technique. Dorsal mobilization of the talus, with the patient in the supine position and ankle dorsiflexion, 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.

Control

Other

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

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Change from baseline ankle range of motion after treatment and at 3 three weeks

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

    The range of movement of the ankle will be measured with a goniometer, following the protocol of Martin et al. The axis will be placed at the lower vertex of the lateral malleolus, the fixed arm parallel to the longitudinal midline of the leg and the mobile arm parallel to the longitudinal midline of the fifth metatarsal. This instrument has shown high reliability (ICCC=0.8-0.9). The higher the graduation, the greater range of motion

  2. Change from baseline biomechanical analysis of gait and balance after treatment and at 3 three weeks

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

    It will be evaluated with an Rs Scan® pressure platform and FootScan® pressure measurement system. This device measures plantar pressure using an X-Y array of resistive pressure sensitive sensors that are sequentially scanned. The system records pressure data when the subject is standing or walking on the platform. The measurements will be made with the basic platform of 0.5m with 4096 sensors with resistive technology and 300Hz data acquisition frequency. The biomechanics of gait will be analyzed with the analysis of the probes and the static balance in a time of 30 seconds.

  3. Change from baseline functionality after treatment and at 3 three weeks

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

    The 2-Minutes Walking Test (2MWT) will be used. It will be carried out in a closed corridor, with a length of 30 m delimited between cones. Before the test, participants must rest for at least 10 minutes. Subsequently, they will be told that they must walk the circuit around the cones as fast as possible, but without running, for 2 minutes. They will be allowed to use aids to walk, slow down or stop to rest if necessary. The distance traveled at the end of the 2 minutes will be recorded by the evaluator. This instrument has shown excellent test-retest reliability (ICC = 0.97)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 16, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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