Trunk Control Training and Walking in Older Adults

Evaluating the Effect of Biofeedback-Based Training on Trunk Neuromuscular Control and Spinopelvic Motion and Loading During Gait in Older Adults With and Without Chronic Low Back Pain

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.

Study Overview

• Status: Withdrawn
• Conditions: Aging; Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Other: Trunk control training

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (Healthy volunteers):

• 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

Inclusion Criteria (Patient group):

• 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 (all subjects):

• 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*

No exclusion criteria shall be based on race, ethnicity, or sex. We will assign subjects to men and women groups for recruitment purposes based on their assigned sex at birth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention; For comparison of trunk control and walking between low back pain and health groups.
Experimental: Trunk control training; Trunk control training is received after baseline measurements in this arm.	Other: Trunk control training; Four sessions of biofeedback trunk movement training, provided once per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute on Aging (NIA); Hebrew SeniorLife
• Investigators: Principal Investigator: Dennis E Anderson, Ph.D., Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Gait; Walking; Wearable Sensors; Neuromuscular control
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2024P000980; T32AG023480 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not currently a plan for sharing in this small preliminary trial; this does not preclude future sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No