Trunk Control Training and Walking in Older Adults

NCT ID: NCT06782919

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-09-30

Brief Summary

The goal of this observational study and clinical trial is to evaluate control of trunk posture and walking biomechanics in 20 older adults with chronic low back pain and 20 older adult healthy volunteers. A second objective of this study is to evaluate the effect of weekly biofeedback-based trunk control training to control of trunk posture and walking biomechanics. The main question it aims to answer is:

• Does training trunk control improve walking biomechanics in older adults? Researchers will compare older adults with and without chronic low back pain to see if trunk control, walking biomechanics, and the effects of training differ between the groups.

Participants will undergo measurements of trunk control in the laboratory, and of walking in both laboratory and outdoor settings. Trunk training will take place once a week for four weeks, and measurements will be repeated after the training protocol.

Conditions

Chronic Low Back Pain (CLBP); Aging

Study Design

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

Study Groups

No Intervention

For comparison of trunk control and walking between low back pain and health groups.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Trunk control training

Trunk control training is received after baseline measurements in this arm.

Group Type: EXPERIMENTAL

Trunk control training

Intervention Type: OTHER

Four sessions of biofeedback trunk movement training, provided once per week.

Interventions

Trunk control training

Four sessions of biofeedback trunk movement training, provided once per week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women, ages 60 - 85 years
• English fluent
• Able to perform activities such as walking, standing, sitting, bending, or lifting without assistance
• Low back pain-free for at least 1 months, characterized by a pain numerical rating scale of <2 (out of 10), and/or <5 (out of 24) on the Roland Morris Disability Questionnaire
• Able to walk without assistance on surfaces of brick, sidewalk, dirt, grass, treadmill, and flat walkway

• Men and women, ages 60 - 85 years
• English fluent
• Current chronic low back pain (lasting at least 1 months) that care was sought for at BIDMC within the past year.
• Pain numerical rating scale of 2-7 (out of 10) and/or 5-19 (out of 24) on the Roland Morris Disability Questionnaire
• Able to perform activities such as walking, standing, sitting, bending, or lifting without assistance
• Able to walk without assistance on surfaces of brick, sidewalk, dirt, grass, treadmill, and flat walkway

Exclusion Criteria

• Self-reported conditions that might alter spine biomechanics, such as a history of traumatic spine injury or spinal surgery; severe scoliosis which needed brace or surgical treatment; neuromuscular conditions such as Parkinson's disease, hemiplegia, symptomatic spinal stenosis, multiple Sclerosis, or muscular dystrophy.
• Back pain with confirmed diagnosis of underlying diseases or structural anomalies such as rheumatoid arthritis, meningitis, or cancer.
• Severe LBP of greater than 7 (out of maximum 10) on self-report pain VAS. (Subjects otherwise eligible and interested will be followed up weekly and scheduled if LBP subsides to below 7/10 on pain VAS).
• Experienced dizziness, lightheadedness, vertigo, or imbalance within the past three months that occurs frequently (3 times or more) or two or more falls in the past year.
• Use of narcotics
• Latex allergies
• Visual problems that are not corrected by glasses/contact lenses.
• Self-reported recent musculoskeletal injury that is currently severely affecting normal activity or movement. Examples of this could include sprains, strains, dislocations, or fractures that prevent one from walking, standing, sitting, bending, or lifting in a normal manner.
• A score ≥10 on the Short Blessed Test, suggesting possible impaired cognitive function or dementia.
• Two* or more of the following self-reported limits in physical function:

• Needing help in activities of daily living (ADLs, such as walking across a small room, bathing, toileting, transferring from bed to chair);
• Unable to walk up and down one flight of stairs without help;
• Unable to walk half a mile without help.
• Short Physical Performance Battery (SPPB) score <4*

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Hebrew SeniorLife

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dennis Anderson

Associate Professor of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis E Anderson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

T32AG023480

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P000980

Identifier Type: -

Identifier Source: org_study_id