Older AdultNCT06844578
Assessment of Postural Control and Balance in the Older Adult
A study testing Experimental Group and Active comparator Group in people with Older Adult and Balance Assessment, run by University of Extremadura at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adult, Balance Assessment, Older Adults, Balance
- What is being tested?
- Experimental Group and Active comparator Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years old
- Residents Ntra. Sra. Del Rosario (Cáceres)
- Consent to participate
- Stable standing
- Tinetti <25
Who cannot join
- Does not meet inclusion criteria
- Medical contraindication to physical exercise
- Wheelchair mobility
- Severe cognitive impairment (>10 Minimental)
- VAS>4
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermería y Terapia Ocupacional
Cáceres, Cáceres, 10003
About this study
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:
Read more
- 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
- Being tested
- Experimental Group, Active comparator Group
- Keywords
- postural control, assessment, older adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
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.
Active comparator GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (G1) or control | No intervention | This group will be composed of 20 participants who will not receive any spe |
| Group 2 (G2) or active comparator | 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. Receives: Other: Active comparator Group |
| Group 2 (G2) or experimental | 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. Receives: Other: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
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.
Measured: 6 weeks
Visual Analogue Scale (VAS)
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.
Measured: 6 weeks
Daniels Test
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.
Measured: 6 weeks
Timed Up and Go (TUG)
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.
Measured: 6 weeks
Borg Scale
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.
Measured: 6 weeks
Tinetti test
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.
Measured: 6 weeks
Functional Independence Measure (FIM)
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.
Measured: 6 weeks
Joint position sense (JPS)
Assesses lumbar proprioceptive repositioning error using the IPhone inclinometer. Degrees
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start17 Feb 2025
- Primary completion17 Feb 2025
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844578
- Sponsor's protocol ID
- 160225
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postural Control and Balance in the Older Adult
- ClinicalTrials.gov ID
- NCT06844578
- Acronym / sponsor ID
- 160225
- Keywords
- postural control, assessment, older adult
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (G1) or control | No intervention | –This group will be composed of 20 participants who will not receive any spe |
| Group 2 (G2) or active comparator | Active comparator | Other: Active comparator Groupwill 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. |
| Group 2 (G2) or experimental | Experimental | Other: Experimental Groupwill 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Over 65 years old
- Residents Ntra. Sra. Del Rosario (Cáceres)
- Consent to participate
- Stable standing
- Tinetti <25
Key exclusion criteria (5 listed)
- Does not meet inclusion criteria
- Medical contraindication to physical exercise
- Wheelchair mobility
- Severe cognitive impairment (>10 Minimental)
- VAS>4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Groupspecific 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. | Other | Group 2 (G2) or experimental |
| Active comparator Groupwhich 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 | Other | Group 2 (G2) or active comparator |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Joint position sense (JPS)
Time frame: 6 weeks
Assesses lumbar proprioceptive repositioning error using the IPhone inclinometer. Degrees
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group and Active comparator Group in people with Older Adult and Balance Assessment, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.