ElderlyNCT07167979
Neck Integration and Eye Movement Training for Fall Risk in the Elderly
A study testing Combining neck muscle strengthening with oculomotor saccade tasks. and Neck Strengthening Only in people with Elderly and Proprioception, Postural Balance, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
Age is one of the primary risk factors for falls, with risk increasing as people get older. Research on fall risk and prevention has identified hundreds of contributing factors, showing that falls have complex and multifactorial causes. Risk factors can be categorized as environmental, extrinsic, or intrinsic. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Proprioception, Postural Balance, Oculomotor System
- What is being tested?
- Combining neck muscle strengthening with oculomotor saccade tasks. and Neck Strengthening Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2025to May 2026
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 65 to 85 years. Able to independently perform mobility necessary for activities of daily living.
- No major medical conditions that significantly affect functional capacity.
Who cannot join
- Presence of central nervous system disorders (e.g., stroke). Severe musculoskeletal or visual injury of the lower limbs within the past three months that prevents participation in assessments.
- Cognitive impairment. Current use of antidepressant medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Role of Neck Sensorimotor Integration and Eye Movement Training on Postural Control and Fall Risk in the Elderly
Age is one of the primary risk factors for falls, with risk increasing as people get older. Research on fall risk and prevention has identified hundreds of contributing factors, showing that falls have complex and multifactorial causes. Risk factors can be categorized as environmental, extrinsic, or intrinsic. Intrinsic factors include physiological aspects-such as reduced lower-limb strength, impaired gait and balance, weaker grip strength, diminished sensory function, and poorer sensorimotor control-as well as psychological aspects, including fear of falling, depression, and cognitive decline. Strongly associated intrinsic risk factors include a history of falls, physical weakness, gait and balance disorders, certain medications, and dizziness. While fixed factors like age and fall history cannot be changed, identifying and targeting modifiable risk factors is crucial for prevention. Among these, gait and balance impairments are considered the most important modifiable intrinsic factors.
- Conditions
- Elderly, Proprioception, Postural Balance, Oculomotor System
- Being tested
- Combining neck muscle strengthening with oculomotor saccade tasks., Neck Strengthening Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combining neck muscle strengthening with oculomotor saccade tasks.Behavioural
he exercise program begins at 30% of 1RM, progressing by first increasing repetitions (8-10 up to 8-12) and then intensity (+5% of 1RM). Training sessions include a 5-minute warm-up, 20 minutes of exercise, and a 5-minute cool-down, performed twice per week for 30 minutes per session.
Neck strengthening is performed using the Iron Neck, which provides constant resistance. Exercises include maintaining a neutral neck position, protraction-retraction, left-right rotation, dynamic figure-8 movements, and synchronized 360° head-body rotations. Each exercise consists of two sets of 8-12 repetitions, with 30 seconds rest between repetitions and 1 minute between sets.
After neck training, participants in the intervention group perform oculomotor saccade tasks while maintaining a neutral head position. Five visual targets appear randomly in front of the participant for 1 second each. The task lasts 40 seconds, followed by 1-2 minutes of rest, and is repeated three times.
Neck Strengthening OnlyBehavioural
he exercise program begins at 30% of 1RM, progressing by first increasing repetitions (8-10 up to 8-12) and then intensity (+5% of 1RM). Training sessions include a 5-minute warm-up, 20 minutes of exercise, and a 5-minute cool-down, performed twice per week for 30 minutes per session. Neck strengthening is performed using the Iron Neck, which provides constant resistance. Exercises include maintaining a neutral neck position, protraction-retraction, left-right rotation, dynamic figure-8 movements, and synchronized 360° head-body rotations. Each exercise consists of two sets of 8-12 repetitions, with 30 seconds rest between repetitions and 1 minute between sets.
| Study group | Role | What they receive |
|---|---|---|
| Neck Strengthening Only | Placebo comparator | The control group will receive an intervention consisting of neck muscle strengthening only. Receives: Behavioral: Neck Strengthening Only |
| Neck Strengthening plus Oculomotor Training | Experimental | The experimental group will receive an intervention combining neck muscle strengthening with oculomotor saccade tasks. Receives: Behavioral: Combining neck muscle strengthening with oculomotor saccade tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck range of motion
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Neck proprioception
Laser Joint Position Error Test
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Neck position
Measurement Method: Craniovertebral Angle
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Neck muscle
craniocervical flexion test, CCFT
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Center of Pressure
force plate
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Oculomotor
tobii eye tracker 5
:Latency and Accuracy
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Dynamic balance
y-balance
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
L/E Muscle strength
MicroFET2 MMT
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Ankle proprioception
Joint Position Reproduction Test Kinesthesia
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
The Falls Efficacy Scale International
The scale scores range from 16 to 64, with higher scores indicating greater severity
Measured: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PEI-CHI LIN, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167979
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240131
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 11 Sep 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Neck Sensorimotor Integration and Eye Movement Training on Postural Control and Fall Risk in the Elderly
- ClinicalTrials.gov ID
- NCT07167979
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240131
- Conditions
- Elderly, Proprioception, Postural Balance, Oculomotor System
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 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.
Age is one of the primary risk factors for falls, with risk increasing as people get older. Research on fall risk and prevention has identified hundreds of contributing factors, showing that falls have complex and multifactorial causes. Risk factors can be categorized as environmental, extrinsic, or intrinsic. Intrinsic factors include physiological aspects-such as reduced lower-limb strength, impaired gait and balance, weaker grip strength, diminished sensory function, and poorer sensorimotor control-as well as psychological aspects, including fear of falling, depression, and cognitive decline. Strongly associated intrinsic risk factors include a history of falls, physical weakness, gait and balance disorders, certain medications, and dizziness. While fixed factors like age and fall history cannot be changed, identifying and targeting modifiable risk factors is crucial for prevention. Among these, gait and balance impairments are considered the most important modifiable intrinsic factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Strengthening Only | Placebo comparator | Behavioral: Neck Strengthening OnlyThe control group will receive an intervention consisting of neck muscle strengthening only. |
| Neck Strengthening plus Oculomotor Training | Experimental | Behavioral: Combining neck muscle strengthening with oculomotor saccade tasks.The experimental group will receive an intervention combining neck muscle strengthening with oculomotor saccade tasks. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Adults aged 65 to 85 years. Able to independently perform mobility necessary for activities of daily living.
- No major medical conditions that significantly affect functional capacity.
Key exclusion criteria (2 listed)
- Presence of central nervous system disorders (e.g., stroke). Severe musculoskeletal or visual injury of the lower limbs within the past three months that prevents participation in assessments.
- Cognitive impairment. Current use of antidepressant medications.
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 |
|---|---|---|
| Combining neck muscle strengthening with oculomotor saccade tasks.he exercise program begins at 30% of 1RM, progressing by first increasing repetitions (8-10 up to 8-12) and then intensity (+5% of 1RM). Training sessions include a 5-minute warm-up, 20 minutes of exercise, and a 5-minute cool-down, performed twice per week for 30 minutes per session. Neck strengthening is performed using the Iron Neck, which provides constant resistance. Exercises include maintaining a neutral neck position, protraction-retraction, left-right rotation, dynamic figure-8 movements, and synchronized 360° head-body rotations. Each exercise consists of two sets of 8-12 repetitions, with 30 seconds rest between repetitions and 1 minute between sets. After neck training, participants in the intervention group perform oculomotor saccade tasks while maintaining a neutral head position. Five visual targets appear randomly in front of the participant for 1 second each. The task lasts 40 seconds, followed by 1-2 minutes of rest, and is repeated three times. | Behavioural | Neck Strengthening plus Oculomotor Training |
| Neck Strengthening Onlyhe exercise program begins at 30% of 1RM, progressing by first increasing repetitions (8-10 up to 8-12) and then intensity (+5% of 1RM). Training sessions include a 5-minute warm-up, 20 minutes of exercise, and a 5-minute cool-down, performed twice per week for 30 minutes per session. Neck strengthening is performed using the Iron Neck, which provides constant resistance. Exercises include maintaining a neutral neck position, protraction-retraction, left-right rotation, dynamic figure-8 movements, and synchronized 360° head-body rotations. Each exercise consists of two sets of 8-12 repetitions, with 30 seconds rest between repetitions and 1 minute between sets. | Behavioural | Neck Strengthening Only |
Primary outcome
Neck range of motion
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Neck proprioception
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Laser Joint Position Error Test
Neck position
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Measurement Method: Craniovertebral Angle
Neck muscle
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
craniocervical flexion test, CCFT
Center of Pressure
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
force plate
Oculomotor
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
tobii eye tracker 5 :Latency and Accuracy
Dynamic balance
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
y-balance
L/E Muscle strength
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
MicroFET2 MMT
Ankle proprioception
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
Joint Position Reproduction Test Kinesthesia
The Falls Efficacy Scale International
Time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.
The scale scores range from 16 to 64, with higher scores indicating greater severity
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 11 Sep 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 Combining neck muscle strengthening with oculomotor saccade tasks. and Neck Strengthening Only in people with Elderly and Proprioception, Postural Balance, run by Kaohsiung Medical University at 1 site in Taiwan.
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 2 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 11 Sep 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Neck range of motion (time frame: Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.). The study lists 10 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 11 Sep 2025.