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Trunk Control Training and Walking in Older Adults

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Withdrawn

Conditions

Aging
Chronic Low Back Pain (CLBP)

Treatments

Other: Trunk control training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06782919
2024P000980
T32AG023480 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

No Intervention
No Intervention group
Description:
For comparison of trunk control and walking between low back pain and health groups.
Trunk control training
Experimental group
Description:
Trunk control training is received after baseline measurements in this arm.
Treatment:
Other: Trunk control training

Trial contacts and locations

1

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Central trial contact

Ben Sibson, Ph.D.

Data sourced from clinicaltrials.gov

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