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

NCT05859685 | Completed

• 1 other identifier: RoM-Ankle
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Old Age; Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (2)

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.

Other: Experimental

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

Other: Control

Interventions

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.

Experimental group

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

Control group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: May 6, 2023
• Primary Completion: June 3, 2023
• Study Completion: July 1, 2023
• Last Updated: May 17, 2024

Record last verified: 2023-05

Locations

ES (1)