Clinical trial NCT06782919: Trunk Control Training and Walking in Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Aging
Keywords: Gait
Walking
Neuromuscular control
Wearable Sensors
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Hebrew SeniorLife
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* Feel safe walking on surfaces of brick, sidewalk, dirt, grass, asphalt, treadmill, and flat walkway

Inclusion Criteria (Low back pain group):

* Men and women, ages 60 - 85 years
* English fluent
* Current chronic low back pain (lasting at least 1 months), characterized by pain numerical rating scale of 2+ (out of 10) and/or 5+ (out of 24) on the Roland Morris Disability Questionnaire
* Able to perform activities such as walking, standing, sitting, bending, or lifting without assistance
* Feel safe walking on surfaces of brick, sidewalk, dirt, grass, asphalt, 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, Multiple Sclerosis, or muscular dystrophy.
* Use of muscle relaxants, steroids, or narcotics
* Latex allergies
* 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.

Primary outcomes:
measure: Trunk neuromuscular control
timeFrame: Baseline, Training sessions (weekly for 4 weeks), and Followup (approximately week 5, 1 week after training completed).
measure: Spinopelvic and lower limb motion
timeFrame: Baseline, and Followup (approximately week 5, 1 week after training completed).
measure: Spinopelvic forces
timeFrame: Baseline, and Followup (approximately week 5, 1 week after training completed).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Dennis E Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: