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

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

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

Study Overview

• Status: Completed
• Conditions: Old Age; Atrophy
• Intervention / Treatment: Other: Experimental; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Universidad Católica San Antonio de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Other: Experimental; 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.
Placebo Comparator: Control group; 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	Other: Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline fear of falls after treatment and at 3 three weeks	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).	Screening visit, within the first seven days after treatment and after three weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline ankle range of motion after treatment and at 3 three weeks	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	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	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.	Screening visit, within the first seven days after treatment and after three weeks follow-up
Change from baseline functionality after treatment and at 3 three weeks	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)	Screening visit, within the first seven days after treatment and after three weeks follow-up

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Study Director: Rubén Cuesta-Barriuso, PhD, Universidad de Oviedo

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2023
• Primary Completion (Actual): June 3, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: RoM-Ankle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No