A Novel Multisensory-Rhythmic Intervention in Geriatric Rehabilitation

NCT06151626 | Recruiting

• 1 other identifier: B-ER-111-482
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Human performance takes shape from the dynamic interaction between person, environment, and task. Goal-directed action is a complex task, which requires the elderly to adapt their motor response according to the environment constraints and task requirements to accomplish the task goal. Among age-related problems, motor control deficits are often the main problems which restricts the frail elderly from maintaining independence for activities of daily living. Therefore, to preserve the quality of life, motor function of the elderly must be taken into consideration, including early detection of motor control problems and development of appropriate intervention strategy for persons with either healthy or pathological brain aging. Rhythmic skill training which is a new mode of dual tasks using rhythmic cueing as an external agent for facilitating an automatized motor task. During training, rhythmic skill training can provide multi-component of sensory stimulation, strengthen motor planning and optimize motor execution, therefore, it will improve the motor performance for the elderly or patients with mild cognitive impairment. In addition, the neuroplastic changes related to sensory processing, selective attention, or working memory demands through music rhythm training can facilitate the cognitive function for the elderly which is a current trend of geriatric rehabilitation. Moreover, the advantage of virtual reality is that it provides important information related to knowledge of result, which can induce better motor and cognitive training effects. Therefore, this research project will focus on assessing and intervening motor adaptation of upper extremity for the healthy elderly and patients with mild cognitive impairment. The first purpose of the project will analyze the difference in efficiency of responsive and predictive grasping motor adaptation among the healthy young adults, healthy elderly and patients with mild cognitive impairment through a test of perturbation-based of pinch-holding-up-activity, and use artificial intelligence for more accurate classification for the grasp pattern of healthy young adults, elderly and patients with mild cognitive impairment. The second one is to verify the effects of virtual-reality based rhythmic skill training system on the motor adaptation capability of upper limb and cognition for the elderly and patients with mild cognitive impairment.

Conditions

Virtual Reality; Hand Mirror; Geriatric; Kinesiology, Applied

Outcome Measures

Primary Outcomes (1)

• Change in responsive grip behavior

  To evaluate change in amplitude of pinch force development or adaptation to perturbation through a test of perturbation-based of pinch-holding-up-activity

  baseline, 8 weeks and 16 weeks

Secondary Outcomes (8)

• Change in the results of Semmes-Weinstein monofilament test

  baseline, 8 weeks and 16 weeks

• Change in the result of Purdue pegboard test

  baseline, 8 weeks and 16 weeks

• Change in the result of Minnesota manual dexterity test

  baseline, 8 weeks and 16 weeks

• Change in the result of Weber Two-Point Discrimination Test

  baseline, 8 weeks and 16 weeks

• The change in the results of Mini-Mental Status Examination (MMSE)

  baseline, 8 weeks and 16 weeks

Study Arms (3)

virtual-reality based rhythmic skill training

EXPERIMENTAL

Participants wear VR headsets and Oculus Touch controllers and undergo rhythm skill training for a total of 35 minutes.

Other: virtual-reality based rhythmic skill training; Other: breathing and muscle relaxation exercises

rhythmic skill training with visual feedback

ACTIVE COMPARATOR

The rhythm skill training activities in this group are the same as the virtual reality-based system. Participants received 35 minutes of rhythm skill training presented through a computer interface

Other: rhythmic skill training with visual feedback; Other: breathing and muscle relaxation exercises

strengthening group

ACTIVE COMPARATOR

The patients receive an upper limb strengthening exercise program under the supervision of a therapist to ensure that the strengthening exercises are performed correctly. This includes: proprioceptive neuromuscular facilitation, resistance training, and tendon gliding exercises.

Other: strengthening group; Other: breathing and muscle relaxation exercises

Interventions

virtual-reality based rhythmic skill training OTHER

Participants wear VR headsets and Oculus Touch controllers and undergo rhythm skill training for a total of 35 minutes.

virtual-reality based rhythmic skill training

rhythmic skill training with visual feedback OTHER

The rhythm skill training activities in this group are the same as the virtual reality-based system. Participants received 35 minutes of rhythm skill training presented through a computer interface

rhythmic skill training with visual feedback

strengthening group OTHER

Participants receive an upper limb strengthening exercise program under the supervision of a therapist to ensure that the strengthening exercises are performed correctly. This includes: proprioceptive neuromuscular facilitation, resistance training, and tendon gliding exercises.

strengthening group

breathing and muscle relaxation exercises OTHER

5 minutes of breathing and muscle relaxation exercises

rhythmic skill training with visual feedback; strengthening group; virtual-reality based rhythmic skill training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Montreal Cognitive Assessment (MoCA) score of 23 or higher,
• Clinical Dementia Rating (CDR) of 0 (for normal subjects) or 1 (for mild cognitive impairment subjects),
• Healthy young participants aged between 20-39 years, healthy older adults and mild cognitive impairment participants aged between 65-85 years,
• No skeletal, muscular, or neurological problems in the upper limbs in the past year, and
• Sufficient visual acuity to complete the tasks.

You may not qualify if:

• Any subjects with significant mental illness, central nervous system disorders, or medical history

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Interventions

Feedback, Sensory; Respiration

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Hsiu-Yun Hsu, Ph.D

CONTACT

886-6-2353535; hyhsu@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 30, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)