Trunk Control Training and Walking in Older Adults

NCT06782919 | Withdrawn

• 2 other identifiers: 2024P000980T32AG023480
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Gait; Walking; Neuromuscular control; Wearable Sensors

Outcome Measures

Primary Outcomes (3)

• Trunk neuromuscular control

  Error in performing trunk tracking tasks.

  Baseline, Training sessions (weekly for 4 weeks), and Followup (approximately week 5, 1 week after training completed).

• Spinopelvic and lower limb motion

  Joint ranges of motion evaluated during walking

  Baseline, and Followup (approximately week 5, 1 week after training completed).

• Spinopelvic forces

  Peak and average spine joint compression and shear forces during walking.

  Baseline, and Followup (approximately week 5, 1 week after training completed).

Study Arms (2)

No Intervention

NO INTERVENTION

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

Trunk control training

EXPERIMENTAL

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

Other: Trunk control training

Interventions

Trunk control training OTHER

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

Trunk control training

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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\*

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute on Aging (NIA): collaborator
• Hebrew SeniorLife: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Study Officials

• Dennis E Anderson, Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 20, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)