30 Participants Needed

Balance Training + Spinal Stimulation for Aging

JH
Overseen ByJungyun Hwang, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Age-related balance and walking issues increase fall risks, leading to injuries, higher healthcare costs, reduced quality of life, and increased morbidity/mortality rates. Preserving functional ability is a crucial public health priority, with the potential to reduce healthcare costs and enhance older adults' quality of life. Declines in balance and walking ability threaten independence. These declines are attributed to spinal network impairments and may be mitigated by targeted interventions aimed at addressing age-related spinal cord impairment to enhance functional outcomes. However, there is a lack of research into how the aging spinal cord affects balance/walking. In older adults, the spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Intervening on age-related impairment of the spinal cord to improve balance/walking ability is a very promising but untapped area of research. A therapeutic approach that combines dynamic balance training with non-invasive electrical spinal stimulation may be effective in preserving functional abilities. This study tests whether electrical stimulation of the spinal lumbar regions is more beneficial than sham stimulation.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take medications affecting the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication. If you are on these medications, you may need to stop taking them to participate.

What data supports the effectiveness of this treatment?

Research shows that combining balance exercises with electrical stimulation can improve balance in older adults. Specifically, a study found that dynamic balance improved when electrical stimulation was used alongside voluntary exercises, suggesting that this combination may help enhance balance control.12345

Is balance training and spinal stimulation safe for humans?

Balance training, including various forms like functional electrical stimulation and perturbation-based training, has been studied in different populations and generally shows improvements in balance and function with minimal serious adverse events reported. However, specific safety data for spinal stimulation combined with balance training is not detailed in the provided studies.46789

How does the Balance Training + Spinal Stimulation treatment differ from other treatments for improving balance in aging individuals?

The Balance Training + Spinal Stimulation treatment is unique because it combines balance exercises with spinal stimulation, which may enhance muscle activation and postural control more effectively than traditional balance exercises alone. This approach could potentially offer greater improvements in balance by integrating both voluntary and electrically stimulated muscle contractions.13101112

Eligibility Criteria

This trial is for older adults aged 65 to 95 with walking speeds slower than 1.0 m/s and balance scores below a certain threshold, who have controlled blood pressure, adequate vision, and no significant cognitive impairment.

Inclusion Criteria

My blood pressure is below 180/100 mmHg.
My vision is better than or equal to 20/70.
My cognitive function is normal, with a MoCA score of 26 or higher.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo five sessions of balance training combined with either active or sham tsDCS over a 2-week period

2 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-day and 10-day post-intervention

2 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Balance Training
  • Spinal Active tsDCS
  • Spinal Sham tsDCS
Trial Overview The study investigates if electrical stimulation of the spinal lumbar regions can improve balance and walking in aging individuals compared to sham (fake) stimulation, alongside dynamic balance training.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active tsDCS treatmentActive Control2 Interventions
Participants will receive 30 minutes of continuous 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.
Group II: Sham tsDCS controlPlacebo Group2 Interventions
Participants will receive 3 minutes of 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

In a study of 32 women aged 62 to 75, all three exercise programs (stair climbing, electrostimulation, and a combination of both) improved dynamic balance after 6 weeks, indicating that physical activity is beneficial for balance in older adults.
However, the stair climbing group showed a greater reliance on visual information for balance control, suggesting that voluntary exercise may be more effective than electrostimulation in enhancing balance strategies among the elderly.
Short-term effects of electrical stimulation superimposed on muscular voluntary contraction in postural control in elderly women.Paillard, T., Lafont, C., Soulat, JM., et al.[2016]
Balance and functional strength training, including Tai Chi, significantly reduced the rate of falls and improved physical functioning in adults aged 65 and older, based on an overview of 5 systematic reviews involving 15,890 participants.
The training showed potential benefits for health-related quality of life, but the evidence was uncertain regarding falls requiring hospitalization, and only one serious adverse event was reported, indicating a generally safe intervention.
Balance and functional training and health in adults: an overview of systematic reviews.McLaughlin, EC., El-Kotob, R., Chaput, JP., et al.[2021]

References

Short-term effects of electrical stimulation superimposed on muscular voluntary contraction in postural control in elderly women. [2016]
A multivariate examination of temporal changes in Berg Balance Scale items for patients with ASIA Impairment Scale C and D spinal cord injuries. [2009]
Increased trunk extension endurance is associated with meaningful improvement in balance among older adults with mobility problems. [2022]
Effect of multi-sensory balance training for unsteady elderly people: pilot study of the "Reykjavik model". [2014]
Proof of concept for perturbation-based balance training in older adults at a high risk for falls. [2011]
Balance and functional training and health in adults: an overview of systematic reviews. [2021]
Long-term effects of a progressive and specific balance-training programme with multi-task exercises for older adults with osteoporosis: a randomized controlled study. [2017]
Functional Electrical Stimulation Plus Visual Feedback Balance Training for Standing Balance Performance Among Individuals With Incomplete Spinal Cord Injury: A Case Series. [2020]
Perturbation-Based Balance Training in Postoperative Individuals With Degenerative Cervical Myelopathy. [2020]
Static balance improvement in elderly after dorsiflexors electrostimulation training. [2018]
Effects of balance training in elderly evaluated by clinical tests and dynamic posturography. [2008]
12.United Statespubmed.ncbi.nlm.nih.gov
Standing balance after vestibular stimulation in Tai Chi-practicing and nonpracticing healthy older adults. [2008]
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