Balance Control for Diabetic Neuropathy

(DPN Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lisa Griffin

Disqualifiers: Foot ulcer, Amputation, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how diabetic peripheral neuropathy (nerve damage in the feet and legs due to diabetes) affects balance and muscle activity. Researchers aim to understand how individuals with and without this condition manage balance, particularly when standing up from a chair or standing still on an unsteady surface. The study involves Balance Control and Recovery, a therapy designed to improve balance. Individuals with type II diabetes and peripheral neuropathy who can stand and walk independently, and do not have foot ulcers or other serious foot issues, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding balance challenges in diabetic neuropathy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for assessing balance control in adults over 50?

Research shows that balance exercises are generally safe for people with diabetic peripheral neuropathy. Studies have found that physical rehabilitation, including balance training, helps improve balance for those at risk of falling due to this condition. Although specific exercises aren't always detailed, the overall approach is well-tolerated.

One study found that exercises involving multiple systems of the body significantly improved balance, stability, and movement. This suggests these exercises could be safe and helpful for people with diabetic neuropathy. Reports of negative effects from these balance exercises are rare.

In summary, evidence suggests these balance exercises are safe and can help improve balance in people with diabetic neuropathy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Balance Control and Recovery treatment for diabetic neuropathy because it aims to enhance balance and mobility in a non-invasive way. Traditional treatments for diabetic neuropathy often focus on managing pain with medications, but this method targets the root issue—balance impairment—through specialized exercises. By improving balance and recovery directly, it has the potential to significantly reduce fall risk in older adults with diabetic peripheral neuropathy, offering a proactive approach to managing the condition.

What evidence suggests that balance control and recovery could be effective for diabetic neuropathy?

This trial will compare balance control and recovery treatments across different participant groups. Research has shown that treatments focused on balance and recovery can help people with diabetic peripheral neuropathy improve their balance and lower their risk of falling. For instance, one study found that exercises targeting multiple systems significantly improved balance, stability, movement, and walking speed. Another study demonstrated that balance rehabilitation improved stability and quality of life for older adults with diabetic neuropathy. While some studies highlight the benefits of balance training, caution is necessary due to certain study limitations. Overall, these findings suggest that such treatments can potentially help those with diabetic peripheral neuropathy achieve better balance. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 50 with diabetic peripheral neuropathy, which affects balance and muscle control. It's also for healthy aging individuals to compare results. Participants must be able to perform physical tasks like standing up from a seated position.

Inclusion Criteria

I have type II diabetes with nerve damage in my hands or feet.

Exclusion Criteria

I have a foot ulcer.

I have had a partial amputation.

I have had a stroke in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial measurements of body weight, height, limb diameter, sensation, and muscle strength are taken

1 session

1 visit (in-person)

Intervention

Participants undergo balance control and muscle activity assessments during sit-to-stand and lateral perturbation tasks

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Balance Control and Recovery

Trial Overview The study tests how well people can control their balance during movements like sitting down or standing up, and how they recover from unexpected disturbances while standing. Muscle activity will be measured using MRI scans of the sciatic nerve.

How Is the Trial Designed?

Group I: older adult with diabetic peripheral neuropathy Experimental Treatment 4 Interventions

Group II: healthy younger adult Active Control 4 Interventions

Group III: Healthy older adult Active Control 4 Interventions

Who Is Running the Clinical Trial?

Lisa Griffin

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

A study involving 38 patients with Type-II diabetes and diabetic neuropathy showed that balance training using the Biodex Balance System significantly improved balance function, as evidenced by a notable increase in the Berg Balance Scale score from 42.68 to 48.89 after 12 training sessions.

The Time Up and Go test also demonstrated significant improvement, with scores decreasing from 17.47 to 13.57, indicating enhanced mobility and balance in the participants after the training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of balance training with Biodex Balance System to improve balance in patients with diabetic neuropathy: A quasi experimental study. Daud, SAH., Rahman, MU., Arsh, A., et al.[2022]

Intraneural facilitation, a novel therapeutic intervention, significantly improved balance measures and neuropathy symptoms in 13 patients with diabetic peripheral neuropathy after 10 treatment sessions.

The intervention led to notable enhancements in the modified Total Neuropathy Scale and the Sensory Organization Test, indicating its potential effectiveness, although some balance components showed no significant change, suggesting areas for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. Alshahrani, A., Bussell, M., Johnson, E., et al.[2018]

Older women with diabetic neuropathy have significantly reduced ankle strength and a decreased ability to recover from balance disturbances compared to both younger women and older women without neuropathy, highlighting the impact of neuropathy on motor function.

The study found that while younger women could recover from a 10% lean, only one older woman without neuropathy could do so, indicating that age and neuropathy both negatively affect balance recovery capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild diabetic neuropathy affects ankle motor function. Gutierrez, EM., Helber, MD., Dealva, D., et al.[2022]

Balance training significantly improved postural control in 19 patients with type 2 diabetic neuropathy, as indicated by reduced sway in low-medium frequency ranges (0.1-0.5 Hz), suggesting a decreased reliance on the vestibular system.

The training enhanced the control of hip muscles, allowing patients to maintain better balance and reducing the need for compensatory movements, which indicates the efficacy of balance training in improving stability for diabetic neuropathy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral characteristics of postural sway in diabetic neuropathy patients participating in balance training. Salsabili, H., Bahrpeyma, F., Esteki, A., et al.[2021]

In subjects with profound sensory neuropathy due to diabetes, lightly touching a support device did not improve the speed or scaling of their automatic postural responses, indicating limited efficacy of this intervention for enhancing balance in these patients.

However, fingertip touch did increase the center of pressure (CoP) velocity towards the support device, suggesting that while it may not improve response timing, it can help guide balance efforts, and heavier touch was necessary for neuropathy patients to enhance their postural response scaling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of light fingertip touch on postural responses in subjects with diabetic neuropathy. Dickstein, R., Peterka, RJ., Horak, FB.[2019]

Diabetic patients with peripheral neuropathy exhibit greater body sway and instability compared to those without neuropathy, increasing their risk of falls.

The study identified a learning effect in the diabetic peripheral neuropathy group when responding to postural disruptions, suggesting that targeted postural control programs could improve their stability and reduce fall risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of perturbation to postural control in individuals with diabetic peripheral neuropathy. Kim, BBJ., Kim, S.[2021]

Patients with diabetic peripheral neuropathy reported greater disability related to dizziness compared to those without neuropathy, as measured by the Dizziness Handicap Inventory, indicating that neuropathy affects their perception of balance issues.

After a standardized vestibular rehabilitation program, patients with neuropathy showed limited improvement in postural control, only benefiting in specific conditions (eyes closed and soft surface), while those without neuropathy improved across all conditions, suggesting that neuropathy may hinder full recovery of balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic polyneuropathy may increase the handicap related to vestibular disease. Aranda, C., Meza, A., Rodríguez, R., et al.[2015]

A 6-week balance training program significantly improved standing balance and postural control in patients with type 2 diabetic neuropathy, as measured by the Biodex stability system and center of pressure fluctuations.

The training enhanced patients' ability to control their balance, particularly in the medial-lateral direction, suggesting that it effectively compensates for the balance issues caused by diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic stability training improves standing balance control in neuropathic patients with type 2 diabetes. Salsabili, H., Bahrpeyma, F., Forogh, B., et al.[2019]

A study involving 50 patients with Diabetic Peripheral Neuropathy (DPN) found that standard offloading insoles can negatively impact static balance, increasing the center of pressure velocity and path length compared to no insole.

The results suggest that while offloading insoles are designed to reduce foot ulcer risk, their design—especially those with arch fill—may compromise balance, indicating a need for new insole designs that maintain foot health without increasing fall risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting the right balance: insole design alters the static balance of people with diabetes and neuropathy. Paton, J., Glasser, S., Collings, R., et al.[2021]

Older adults with type 2 diabetes, especially those with diabetic neuropathy, show significant impairments in postural control when sensory inputs are disturbed, indicating a need for targeted interventions.

The Wii Balance Board is an effective and affordable tool for assessing balance impairments in individuals with diabetes, helping to identify those at risk and potentially guiding early rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural performance assessment in aging people with diabetes and diabetic peripheral neuropathy using a Wii balance board. Vargas Matamala, M., Tapia, C., Salvador Sagüez, F., et al.[2023]

A patient with diabetic sensory neuropathy showed significant balance impairment, leading to falls during challenging tasks, as assessed by Computerized Dynamic Posturography.

The use of ankle-foot orthoses (AFOs) improved the patient's balance dramatically, increasing the composite balance score fourfold, suggesting that AFOs can enhance stability and reduce fall risk in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Ankle-Foot Orthoses on Balance Impairment: Single-Case Study. Rao, N., Aruin, A.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268776/

A Systematic Review of the Effect of Physical Rehabilitation on ... While physical rehabilitation is sufficient to improve balance in individuals with diabetic peripheral neuropathy who are at risk of falling, few interventions ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06544876?cond=Endocrinology&locStr=United+States&country=United+States&aggFilters=status:%2Cages:adult

Balance Control and Recovery in Diabetes Peripheral ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1360859225000592

Multifactorial balance rehabilitation in diabetic neuropathy ... This study investigates the effect of a multifactorial balance rehabilitation program on postural stability, fall risk, and quality of life in elderly ...

4. bmcneurosci.biomedcentral.com bmcneurosci.biomedcentral.com/articles/10.1186/s12868-024-00924-6

Effects of multisystem exercises on balance, postural stability ... The study concluded that multisystem exercises resulted in significant improvement in balance, postural stability, mobility, and walking speed, along with ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/09593985.2024.2391823

Content and effects of balance training in people with ... Balance training does seem to improve balance outcomes in people with DPN, but given the methodological limitations, interpretation must be cautious.

6. nature.com nature.com/articles/s41392-025-02175-1

Diabetic neuropathy: cutting-edge research and future ... Cognitive impairment in diabetes is attributed to chronic hyperglycemia leading to cerebrovascular disease, neurodegeneration, and inflammation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05127538

NCT05127538 | Balance and Gait in Diabetic Neuropathy The aim of the study is to evaluate the effects of neuropathic pain due to type 2 diabetes on balance and gait. The study is a prospective controlled study.