Assessment of Postural Control and Balance in the Older Adult

February 25, 2025 updated by: Alejandro Caña Pino, University of Extremadura

A randomised clinical trial is proposed, using a probabilistic allocation design to ensure an equitable distribution of participants between the different intervention and control groups, minimising bias and increasing the internal validity of the results.

The trial foresees the voluntary participation of a total of 60 subjects, selected on the basis of previously established criteria and meeting specific characteristics criteria previously established and who meet the specific characteristics required for the study. The distribution of the participants in the clinical trial will be structured into three groups with characteristics and specific objectives, among which the following groups are highlighted:

  • Group 1 (G1) or control: This group will be composed of 20 participants who will not receive any specific intervention related to gerontogymnastics or occupational therapy programmes designed from occupational therapy.
  • Group 2 (G2) or experimental with gerontogymnastics: this group will be made up of 20 participants who will receive exclusively an intervention based on gerontogymnastics.

This programme will include a series of exercises adapted to the needs of the older adult population, with an emphasis on population, with emphasis on improving balance, muscle strength, flexibility and motor coordination.

Group 3 (G3) or experimental: will be composed of 20 participants who will receive a combined intervention. This will consist of a gerontogymnastics programme, mentioned above, merged with a specific occupational therapy plan, in which exercises such as:

  • Unipodal stability
  • Gait re-education
  • Muscle strength
  • Stationary gait

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cáceres, Spain, 10003
        • Facultad de Enfermería y Terapia Ocupacional

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over 65 years old
  • Residents Ntra. Sra. Del Rosario (Cáceres)
  • Consent to participate
  • Stable standing
  • Tinetti <25

Exclusion Criteria:

  • Does not meet inclusion criteria
  • Medical contraindication to physical exercise
  • Wheelchair mobility
  • Severe cognitive impairment (>10 Minimental)
  • VAS>4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1 (G1) or control
This group will be composed of 20 participants who will not receive any spe
Active Comparator: Group 2 (G2) or active comparator

will consist of 20 participants who will receive an intervention based exclusively on gerontogymnastics.

This programme will include a series of exercises adapted to the needs of the older adult population, with emphasis on improving balance, muscle strength, flexibility and motor coordination.

motor coordination.
Other: Active comparator Group

which will be carried out over a period of 6 weeks, with a total of 12 scheduled sessions of 45 minutes each. Participants who will exclusively receive an intervention based on gerontogymnastics.

This programme will include a series of exercises adapted to the needs of the older adult population, with an emphasis on improving balance, muscle strength, flexibility and motor coordination. These include:

  • Shoulder raises
  • Hip flexion
  • Knee flexion
  • Trunk rotations
  • Ankle dorsiflexion
Experimental: Group 2 (G2) or experimental
will consist of 20 participants who will receive a combined combined intervention. This will consist of a programme of gerontogymnastics, and a specific occupational therapy plan, in which exercises will be carried out, such as which will include exercises such as: Unipodal Stability, Gait Re-education, Muscle Strength, Stationary Gait.
Other: Experimental Group

specific intervention programme in the experimental group, which will be carried out over a period of 6 weeks, with a total of 12 scheduled sessions of 45 minutes each. The programme will be aimed at improving various functional capacities, through specifically designed exercises, including:

  • Unipodal stability: Exercises focused on strengthening balance by maintaining a posture on one foot, which is key to preventing falls and improving postural stability.
  • Gait re-education: Activities aimed at correcting and adjusting gait technique, promoting an efficient and safe movement pattern.
  • Muscle strength: Exercises aimed at muscle strengthening, especially in the lower limbs, to increase endurance and stability during daily activities.
  • Stationary walking: Practices that simulate stationary walking, improving cardiovascular endurance and motor coordination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination (MMSE)
Time Frame: 6 weeks
The MMSE is used to assess global cognitive function, identifying possible deficits in memory, language, orientation and attention on a scale from 0 to 30, where 30 indicates global cognitive function, and 0 may indicate severe cognitive impairment.
6 weeks
Visual Analogue Scale (VAS)
Time Frame: 6 weeks
The VAS is a tool used to measure the level of pain intensity perceived by the patient. It allows participants to rate pain on a numerical scale from 0 to 10, with 0 being no pain and 10 being the maximum intensity.
6 weeks
Daniels Test
Time Frame: 6 weeks
This test is intended to assess muscle function, specifically the gluteus maximus, quadriceps and hamstrings. It is used to determine the strength and endurance of these muscles in relation to postural stability and gait on a scale of 0 to 5, where 0 indicates no strength or inability to perform the movement and 5 indicates normal strength or optimal muscle function.
6 weeks
Timed Up and Go (TUG)
Time Frame: 6 weeks
The TUG is an assessment method used to evaluate functional mobility and balance. It consists of measuring the time it takes for a subject to get up from a chair, walk three metres, turn around and sit down again.
6 weeks
Borg Scale
Time Frame: 6 weeks
The Borg scale is used to measure the subjective perception of physical exertion during an activity. Participants rate their perception of fatigue as a function of exertion on a scale of 0 to 10.
6 weeks
Tinetti test
Time Frame: 6 weeks
The Tinetti is a tool designed to assess the risk of falls in older adults. It examines postural stability and gait, allowing the identification of balance and mobility deficits that could compromise patient safety.
6 weeks
Functional Independence Measure (FIM)
Time Frame: 6 weeks
The FIM is used to assess a patient's functional independence in various activities of daily living (ADLs), such as grooming, mobility and communication. It is a key tool for measuring functionality-related quality of life.
6 weeks
Joint position sense (JPS)
Time Frame: 6 weeks
Assesses lumbar proprioceptive repositioning error using the IPhone inclinometer. Degrees
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Extremadura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Actual)

February 17, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 160225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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