Neck Integration and Eye Movement Training for Fall Risk in the Elderly

NCT ID: NCT07167979

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2026-05-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neck Strengthening Only

The control group will receive an intervention consisting of neck muscle strengthening only.

Group Type: PLACEBO_COMPARATOR

Neck Strengthening Only

Intervention Type: BEHAVIORAL

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.

Neck Strengthening plus Oculomotor Training

The experimental group will receive an intervention combining neck muscle strengthening with oculomotor saccade tasks.

Group Type: EXPERIMENTAL

Combining neck muscle strengthening with oculomotor saccade tasks.

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Neck Strengthening Only

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaohsiung Medical University

OTHER

Sponsor Role: lead

Responsible Party

PEI-CHI LIN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oculomotor training device

Kaohsiung City, Sanmin District, Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(I)-20240131

Identifier Type: -

Identifier Source: org_study_id