Balance DisordersAOBALNCT07199790
Action Observation and Exercise for Balance in Older Adults: A Randomized Trial.
A study testing Action observation videos and Therapeutic exercise in people with Balance Disorders and Fall, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance Disorders, Fall, Elderly (People Aged 65 or More)
- What is being tested?
- Action observation videos and Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 31 Dec 2027
- 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
- Individuals over 65 years of age with low or moderate risk of falls as measured by the Timed Up and Go test, who have voluntarily signed the informed consent form and are willing to follow the protocol proposed by the research team.
Who cannot join
- Presence of uncorrected visual impairments preventing screen observation; diagnosis of a condition that makes adherence to the protocol impossible (cognitive, oncological, psychiatric, psychological, vestibular, neurological, etc.); presence of a musculoskeletal injury at the time of selection and/or prior participation in studies involving movement representation methods.
- Withdrawal criteria: Lack of participant compliance, defined as failure to complete at least 80% of the intervention sessions and assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Action Observation Combined With Therapeutic Exercise on Balance and Falls in Community-Dwelling Adults ≥65: A Randomized Trial
The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk.
Read the detailed description
Background: Action observation activates brain networks involved in motor learning and has shown benefits in neurological and musculoskeletal populations (improvement of balance, gait, and pain). However, evidence in older adults at risk of falls and the role of the observed model remain underexplored. Objectives: The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk. Secondary objectives include comparing efficacy according to the observed model, and analyzing effects on strength, fear of falling, adherence, and fall incidence. Methods: A single-blind, randomized clinical trial of 24 weeks (12 intervention, 12 follow-up) is planned. A total of 93 participants will be allocated to 3 groups: exercise, exercise with action observation of a standard model, and exercise with action observation of a self-selected model. The intervention (therapeutic exercise program and/or action observation of the same program) will be delivered three times per week with biweekly progressions. The primary outcome will be balance (static balance measured by sway area on force platform and dynamic balance assessed by Timed Up and Go test). Secondary outcomes will include handgrip and lower limb strength, fear of falling, adherence, and fall incidence. Assessments will be conducted at weeks 0, 6, 12, and 24. Both ITT and per-protocol analyses will be performed, with intra- and inter-group comparisons (p<0.05). Discussion: If effective, this low-cost, low-technology program could be easily scaled up in primary care and community settings, with potential impact on public health and physiotherapy. Applicability may also extend to neurorehabilitation and secondary prevention in frailty. Anticipated limitations: adherence, partial blinding, and external validity limited to community-dwelling older adults. Implications: development of concise practice guidelines, standardized audiovisual materials, and future research in clinical populations.
- Conditions
- Balance Disorders, Fall, Elderly (People Aged 65 or More), Exercise, Observation, Physical Therapist
- Being tested
- Action observation videos, Therapeutic exercise
- Keywords
- balance, strength, referent, exercise therapy, healthy aging, action observation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation videosOther
The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.
Therapeutic exerciseOther
The therapeutic exercise program aimed at improving balance and preventing falls will be carried out three times per week (Monday, Wednesday, and Friday), with each session lasting 30-45 minutes. Each session will be structured into three blocks: a warm-up of 5-10 minutes, a main block focused on balance and strength lasting 20-25 minutes, and a cool-down of 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants will perform a therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. Receives: Other: Therapeutic exercise |
| Standard Referent Group | Experimental | Participants will perform the same therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a standard model performing the same program, also three times per week. Receives: Other: Action observation videos; Other: Therapeutic exercise |
| Self-Selected Referent Group | Experimental | Participants will perform the therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a model they have personally selected based on perceived similarity, also three times per week, performing the same program. Receives: Other: Action observation videos; Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
Center of pressure analysis: The displacement of the center of pressure (CPD) of the participants will be measured through posturographic tests performed on a force platform. The following variables related to the center of pressure (CoP) will be calculated: the roll area (in square millimeters) and the distribution of the weight load on both sides.
Measured: 12 weeks
Dynamic balance
To assess participants' dynamic balance, the Timed Up and Go test (39-41) will be used. This test records the time, in seconds, it takes for an individual to rise from a chair, walk three meters, turn around, return, and sit down again. It is one of the most widely used tools in older adults due to its simplicity, quick administration, and high reliability. Intra- and inter-rater reliability values range from 0.94 to 0.99, and test-retest reliability from 0.95 to 0.99. Moreover, it shows significant correlations with lower-limb strength, the Berg Balance Scale, and other functional assessments.
Measured: 12 weeks
Secondary outcomes (6)
Trunk and lower extremity muscle strength
Analogue dynamometry will be used as an evaluation method and will be recorded in Newtons (N) with the Saehan SKU SH5007 back, leg and chest dynamometer.
Measured: 12 weeks
Satisfaction assessed by a selfcreate questionnaire
A questionnaire specifically designed to evaluate participants' satisfaction with their experience in the study will be used once they have completed their participation.
Measured: 12 weeks
Grip strength
A digital dynamometer will be used as the assessment method, and results will be recorded in kilograms using the K-Grip hand dynamometer (K-Invent®, Montpellier, France) through the grip strength test. Three 3-second trials will be performed with each hand, with 30 seconds of rest between attempts, and the best result will be selected.
Measured: 12 weeks
Safety and fear of falling
The validated Spanish version of the Short Falls Efficacy Scale-International (Short FES-I) will be used. This scale comprises 7 items related to daily life activities, each rated on a 4-point scale: not at all concerned (1 point), somewhat concerned (2 points), fairly concerned (3 points), or very concerned (4 points). The total score ranges from 7 to 28, with higher scores indicating greater fear of falling. The Short FES-I has shown high internal consistency (Cronbach's alpha = 0.90; intraclass correlation coefficient = 0.89), good test-retest reliability (Spearman's rho = 0.76), and strong concurrent criterion validity, as evidenced by its high correlation with the original FES-I (Spearman's rho = 0.90).
Measured: 12 weeks
Adherence
Adherence will be evaluated by calculating the ratio between the number of sessions completed and the total number of sessions scheduled. Recording will be carried out using a weekly log sheet filled out by participants and supervised by the research team.
Measured: 12 weeks
Incidence of falls
Fall events will be recorded through self-reporting during the entire intervention and follow-up period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Balance DisordersStudies 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
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania López Hernández, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199790
- Sponsor's protocol ID
- 09/2025
- Acronym
- AOBAL
- Status last verified
- May 2026
- First submitted
- 22 Sep 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.
PubMed 23523272Zhang M, Zhang T, He Y, Luo J. Comparison of motor imagery and action observation on lower limb function in older adults: a systematic review and meta-analysis. Geriatr Nurs. 2025 Sep-Oct;65:103468. doi: 10.1016/j.gerinurse.2025.103468. Epub 2025 Jul 5.
PubMed 40618719Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.
PubMed 31938708Lopez Hernandez T, Caparo Ferre M, Salas-Huetos A, Salvat Salvat I, Adillon Camon C. Influence of referent selection on balance in action observation: A randomized controlled trial. Complement Ther Med. 2025 Jun;90:103150. doi: 10.1016/j.ctim.2025.103150. Epub 2025 Feb 20.
PubMed 39986658
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Action Observation Combined With Therapeutic Exercise on Balance and Falls in Community-Dwelling Adults ≥65: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07199790
- Acronym / sponsor ID
- AOBAL / 09/2025
- Conditions
- Balance Disorders, Fall, Elderly (People Aged 65 or More), Exercise, Observation, Physical Therapist
- Keywords
- balance, strength, referent, exercise therapy, healthy aging, action observation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 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.
The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk.
Detailed description
Background: Action observation activates brain networks involved in motor learning and has shown benefits in neurological and musculoskeletal populations (improvement of balance, gait, and pain). However, evidence in older adults at risk of falls and the role of the observed model remain underexplored. Objectives: The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk. Secondary objectives include comparing efficacy according to the observed model, and analyzing effects on strength, fear of falling, adherence, and fall incidence. Methods: A single-blind, randomized clinical trial of 24 weeks (12 intervention, 12 follow-up) is planned. A total of 93 participants will be allocated to 3 groups: exercise, exercise with action observation of a standard model, and exercise with action observation of a self-selected model. The intervention (therapeutic exercise program and/or action observation of the same program) will be delivered three times per week with biweekly progressions. The primary outcome will be balance (static balance measured by sway area on force platform and dynamic balance assessed by Timed Up and Go test). Secondary outcomes will include handgrip and lower limb strength, fear of falling, adherence, and fall incidence. Assessments will be conducted at weeks 0, 6, 12, and 24. Both ITT and per-protocol analyses will be performed, with intra- and inter-group comparisons (p<0.05). Discussion: If effective, this low-cost, low-technology program could be easily scaled up in primary care and community settings, with potential impact on public health and physiotherapy. Applicability may also extend to neurorehabilitation and secondary prevention in frailty. Anticipated limitations: adherence, partial blinding, and external validity limited to community-dwelling older adults. Implications: development of concise practice guidelines, standardized audiovisual materials, and future research in clinical populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Therapeutic exerciseParticipants will perform a therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. |
| Standard Referent Group | Experimental | Other: Action observation videos, Other: Therapeutic exerciseParticipants will perform the same therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a standard model performing the same program, also three times per week. |
| Self-Selected Referent Group | Experimental | Other: Action observation videos, Other: Therapeutic exerciseParticipants will perform the therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a model they have personally selected based on perceived similarity, also three times per week, performing the same program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Individuals over 65 years of age with low or moderate risk of falls as measured by the Timed Up and Go test, who have voluntarily signed the informed consent form and are willing to follow the protocol proposed by the research team.
Key exclusion criteria (2 listed)
- Presence of uncorrected visual impairments preventing screen observation; diagnosis of a condition that makes adherence to the protocol impossible (cognitive, oncological, psychiatric, psychological, vestibular, neurological, etc.); presence of a musculoskeletal injury at the time of selection and/or prior participation in studies involving movement representation methods.
- Withdrawal criteria: Lack of participant compliance, defined as failure to complete at least 80% of the intervention sessions and assessments.
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 |
|---|---|---|
| Action observation videosThe participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement. | Other | Self-Selected Referent Group, Standard Referent Group |
| Therapeutic exerciseThe therapeutic exercise program aimed at improving balance and preventing falls will be carried out three times per week (Monday, Wednesday, and Friday), with each session lasting 30-45 minutes. Each session will be structured into three blocks: a warm-up of 5-10 minutes, a main block focused on balance and strength lasting 20-25 minutes, and a cool-down of 5-10 minutes. | Other | Exercise Group, Self-Selected Referent Group, Standard Referent Group |
Primary outcome
Static balance
Time frame: 12 weeks
Center of pressure analysis: The displacement of the center of pressure (CPD) of the participants will be measured through posturographic tests performed on a force platform. The following variables related to the center of pressure (CoP) will be calculated: the roll area (in square millimeters) and the distribution of the weight load on both sides.
Dynamic balance
Time frame: 12 weeks
To assess participants' dynamic balance, the Timed Up and Go test (39-41) will be used. This test records the time, in seconds, it takes for an individual to rise from a chair, walk three meters, turn around, return, and sit down again. It is one of the most widely used tools in older adults due to its simplicity, quick administration, and high reliability. Intra- and inter-rater reliability values range from 0.94 to 0.99, and test-retest reliability from 0.95 to 0.99. Moreover, it shows significant correlations with lower-limb strength, the Berg Balance Scale, and other functional assessments.
6 secondary outcomes
Trunk and lower extremity muscle strength
Time frame: 12 weeks
Satisfaction assessed by a selfcreate questionnaire
Time frame: 12 weeks
Grip strength
Time frame: 12 weeks
Safety and fear of falling
Time frame: 12 weeks
Adherence
Time frame: 12 weeks
Incidence of falls
Time frame: 12 weeks
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 7 May 2026.
- Background: PubMed 23523272Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.
- Background: PubMed 40618719Zhang M, Zhang T, He Y, Luo J. Comparison of motor imagery and action observation on lower limb function in older adults: a systematic review and meta-analysis. Geriatr Nurs. 2025 Sep-Oct;65:103468. doi: 10.1016/j.gerinurse.2025.103468. Epub 2025 Jul 5.
- Background: PubMed 31938708Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.
- Background: PubMed 39986658Lopez Hernandez T, Caparo Ferre M, Salas-Huetos A, Salvat Salvat I, Adillon Camon C. Influence of referent selection on balance in action observation: A randomized controlled trial. Complement Ther Med. 2025 Jun;90:103150. doi: 10.1016/j.ctim.2025.103150. Epub 2025 Feb 20.
- Individual participant dataSharing planned: No
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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 Action observation videos and Therapeutic exercise in people with Balance Disorders and Fall, run by University Rovira i Virgili 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 1 inclusion and 2 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 7 May 2026. 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?
Static balance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07199790, which also lists 4 linked publications.
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 7 May 2026.