CClinicalTrials.gg
CompletedNCT02992275IMAGINE+NMESUpdated Feb 8, 2023

NMES to Improve Hip Abductor Strength and Balance

An interventional study of Neuromuscular electrical stimulation (NMES) and Multi-Modality Balance Intervention (MMBI) in Postural Balance, sponsored by Baltimore VA Medical Center. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Baltimore VA Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

This study will examine the addition of neuromuscular electrical stimulation (NMES) on the hip abductors during strength training and a fall prevention program for improving muscle strength and improving balance. All individuals in this study will receive NMES to their hip abductors and will participate in a fall reduction program.

Read the detailed description

Falls are a leading cause of disability in older adults. Decreased lower extremity muscle mass and strength contribute to balance and mobility limitations. Our more recent work also suggests that in addition to the traditional targets of muscle mass of the thigh and leg muscles, dysfunction of the hip abductors may contribute to balance and mobility limitations resulting in increased fall risk. Older adults with impaired hip abductor muscles demonstrate increased amounts of intramuscular fat (IMAT) in and around the muscles, decreased hip abductor strength, lower balance scores, increased gait variability (a predictor of future falls), and poor stepping mechanics when recovering from a balance perturbation. Increased IMAT and muscle dysfunction of the hip abductors may contribute to poor hip abductor muscle recruitment and make changing these muscle during a traditional intervention difficult. Neuromuscular electrical stimulation (NMES) is one method to improve muscle mass, strength and quality in older adults, but has not traditionally been used on the hip abductors. We propose that a targeted multimodality balance intervention (MMBI) focused on the lateral and diagonal stepping and hip abductor strengthening when combined with NMES will result in improvements in mobility and balance.

02

Conditions studied

  • Postural Balance

Keywords

  • Hip
  • Muscle
  • Skeletal/physiopathology
03

In context

Lead sponsor

Baltimore VA Medical Center is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Mobility and balance limitations as demonstrated by a self-reported fall within the past year or requiring greater than 8 seconds to complete the 4-square step test

Exclusion criteria

-

Exclusion Criteria:

  1. Cardiovascular Risks: Poorly controlled hypertension (>160/100); or patient report of: symptomatic angina at rest or during exercise, syncope without known resolution of cause, or a significant coronary event (such as a MI) in the past six months
  2. COPD requiring home oxygen
  3. Contraindications to resistance training, including a self-reported history of intracranial or retinal bleeding in the last year or Diabetes with active proliferative retinopathy
  4. Patient report of significant spinal stenosis that would limit participation in the exercise intervention
  5. Non-ambulatory mobility status or a transtibial or transfemoral amputation
  6. Dementia (on medical record review or mini-mental status exam score \<24).
  7. Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    NMES + MMBI

    Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention

    Other: Neuromuscular electrical stimulation (NMES) · Other: Multi-Modality Balance Intervention (MMBI)

Interventions

  • OtherNeuromuscular electrical stimulation (NMES)

    Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 24 weeks

  • OtherMulti-Modality Balance Intervention (MMBI)

    Participants will attend a group balance class that focuses on movement and obstacle negotiation 3 times per week for 24 weeks

06

What researchers measure

Primary outcomes

  1. Mobility

    Mobility will be measured with the use of the mini-BesTest

    Time frame: 6 months

Secondary outcomes

  1. Balance

    Balance will be measured with the four-square step test

    Time frame: 6-months

  2. Muscle Strength

    Muscle strength will be measured as hip abductor strength quantified by use of a biodex

    Time frame: 6-months

07

Study locations

1 site
  • Baltimore VA Medical Center
    Baltimore, Maryland 21201, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02992275
Lead sponsor
Baltimore VA Medical Center
Responsible party
Odessa Addison (Research Scientist, Baltimore VA Medical Center) — Principal investigator
First posted
Dec 14, 2016
Start date
Jun 1, 2017
Primary completion
Oct 1, 2021
Completion
Dec 31, 2022
Last update
Feb 8, 2023

Study contacts

Les Katzel, MD, PhD
study director · Director Baltmore GRECC
Odessa Addison, DPT, PhD
principal investigator · Research Scientist

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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