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

NCT07167979 | Active Not Recruiting

• 1 other identifier: KMUHIRB-F(I)-20240131
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Neck range of motion

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Neck proprioception

  Laser Joint Position Error Test

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Neck position

  Measurement Method: Craniovertebral Angle

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Neck muscle

  craniocervical flexion test, CCFT

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Center of Pressure

  force plate

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Oculomotor

  tobii eye tracker 5 :Latency and Accuracy

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Dynamic balance

  y-balance

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• L/E Muscle strength

  MicroFET2 MMT

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

• Ankle proprioception

  Joint Position Reproduction Test Kinesthesia

  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

  Assessments will be conducted at baseline, and at three, six, and twelve months post-intervention.

Study Arms (2)

Neck Strengthening Only

PLACEBO COMPARATOR

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

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.

Behavioral: Combining neck muscle strengthening with oculomotor saccade tasks.

Interventions

Combining neck muscle strengthening with oculomotor saccade tasks. 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.

Neck Strengthening plus Oculomotor Training

Neck Strengthening Only 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 Only

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Oculomotor training device

Kaohsiung City, Sanmin District, 807, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 11, 2025
• Study Start: August 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

TW (1)