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Clinical Trials/NCT05859685
NCT05859685CompletedNot Applicable

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 site in 1 country12 target enrollmentStarted: May 6, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Change from baseline fear of falls after treatment and at 3 three weeks

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
65 Years to 80 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: 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

Intervention: Control (Other)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rubén Cuesta-Barriuso, PhD

Principal Investigator

Universidad Católica San Antonio de Murcia

Study Sites (1)

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