Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults

NCT06348667 | Completed

• 1 other identifier: 3184794
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults. The main questions it aims to answer are:

• Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.
• Engage in 5 rounds of 40-second balance exercises using the BB. Researchers will compare the intervention group's outcomes with those of the control group to determine the effectiveness of adding BB exercises in improving foot and ankle parameters related to fall prevention.

Conditions

Fall

Keywords

Ankle stability; Ankle mobility; Balance training; Older Adults

Outcome Measures

Primary Outcomes (7)

• Foot and ankle pain

  Foot-Function Index (FFI) scale. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability, and activity limitation. It offers a score from 0 to 267, with higher scores indicating worse outcomes. The total score obtained on the scale is divided by 207 and multiplied by 100 to obtain a final percentage.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

• Foot and ankle strength

  Suiff Pro dynamometer. Movements: dorsal and plantar flexion, inversion, eversion of the ankle. Flexion and extension of the big toe.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

• Foot and ankle ROM

  Video recording + Kinovea. Movements: dorsal and plantar flexion, inversion, eversion of the ankle. Flexion and extension of the big toe.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

• Ankle dorsiflexion under load

  Weight bearing Lunge test. This test is used to assess ankle dorsiflexion. The movement will be recorded for later processing with Kinovea to determine the angle.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

• Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface)

  K-Force plates will be used during bipedal and monopodal stances. First on a firm surface with eyes open, and then with eyes closed. The same procedure will be performed on a soft surface.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

• Monopodal stability

  Single-leg Stance Test. During this test, the time that the participant is able to maintain single-leg stance without arm support and with eyes open is recorded.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

• Functional stability

  Timed Up and Go test. In this test, the participant is seated in a chair with a cone placed 3 meters in front of them. Upon signal, they stand up, walk to the cone, walk around it, come back, and sit down again. The time taken to complete the task will be recorded.

  Pre, after 5 weeks of intervention, after 1 month of the end of the study

Study Arms (2)

Experimental

EXPERIMENTAL

16 subjects who will perform BB exercises twice a week for 5 weeks under the supervision of a physiotherapist. Each session (50') will include a warm-up of 10' of slow walking, joint mobility, and stretching. Then, BB exercises will be performed, followed by 10' of relaxation and stretching to cool down. BB exercises: * Ankle mobility: single-leg ankle dorsiflexion movements in a standing position on the BB with slight assistance from the parallel bars to perform the movement correctly. The BB will be set with the forefoot fixed and the rearfoot with medial drop, to facilitate dorsiflexion by combining dorsal flexion and pronation. 3 sets of 15 repetitions, with a 1' rest between sets. * Balance: BB will be set with instability in the forefoot and fixed rearfoot, to produce mediolateral instability of the CoP. The exercise will be maintaining balance on the BB while attempting to keep the lateral edges of the board from touching the ground. Five rounds of 40" work and 1' rest.

Other: Specific ankle stability exercises

Control

ACTIVE COMPARATOR

16 participants who will perform their conventional exercises protocol. The group exercise sessions (45') take place twice a week. Participants sit in a circle in the room, with the physiotherapist in the center to provide instructions, and perform: * Warm-up: 5' of joint mobility exercises. Shoulder rotations, elbow flexion and extension, knee flexion and extension, ankle rotations, and standing up and sitting down 5 times. * Main part: 25-30' (with music). Energetic arm movements, e.g. raising and lowering, front and back, inward and outward arm circles, and lateral shoulder raises like "little birds"... These exercises are performed fast within a controlled ROM. CORE work is done while seated on the edge of the chair, bringing knees to the shoulders and moving the legs up and down. Finally, they stand up and sit down several times, and try to maintain an isometric squat position. * Cool down: 5-7' of stretching, mainly consisting of active neck mobility and arm stretching.

Other: Conventional physiotherapy exercises program

Interventions

Specific ankle stability exercises OTHER

Exercise program specifically designed to address ankle dorsiflexion and mediolateral displacement of the center of pressure, using the described device (BB). Done twice a week for 5 weeks.

Experimental

Conventional physiotherapy exercises program OTHER

Conventional exercise program performed in the center twice a week, of which all participants are part.

Control

Eligibility Criteria

• Age: 75 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Ability to walk at least 5 meters without the need for technical aids
• Achieving a minimum score of 24 on the Mini-Mental State Examination, ensuring cognitive capacity to understand the study
• Attaining a minimum score of 19 on the Tinetti scale

You may not qualify if:

• Not having participated in any specific stability or ankle training program in the last 6 months
• Not experiencing any musculoskeletal or neural disorders that could hinder study participation (e.g., diabetic foot, hemiplegia, or amputations)
• Individuals at severe risk of falling and those who are solely able to stand without being able to walk, according to the Tinetti scale

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Rodrigo Martin-San Agustin

Valencia, Spain

Location

Study Officials

• Rodrigo Martín-San Agustín, Doctor

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 5, 2024
• Study Start: March 7, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

ES (1)