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

Trial Summary

What is the purpose of this trial?

In this study the effects of diabetic peripheral neuropathy will be assessed on balance control, balance recovery, and muscle electrical activity in adults over 50 years. Aim 1: Determine muscle activity and balance control during a sit-to-stand in adults age above 50 with and without diabetic peripheral neuropathy. Aim 2: Assess local balance recovery and latency responses to lateral surface perturbation during quiet standing.

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 data supports the effectiveness of the treatment Balance Control and Recovery for diabetic neuropathy?

Research shows that balance training, like the Biodex Balance System, can improve balance in patients with diabetic neuropathy. This suggests that treatments focusing on balance control can help manage balance issues in these patients. ^{1 2 3 4 5}

Is the Balance Control treatment safe for humans?

The research does not provide specific safety data for the Balance Control treatment, but it focuses on improving balance in people with diabetic neuropathy, which suggests it is generally considered safe for this purpose. ^{4 6 7 8 9}

How does this treatment for diabetic neuropathy differ from other treatments?

This treatment focuses on balance training using systems like the Biodex Balance System, which helps improve standing balance and postural control in patients with diabetic neuropathy by enhancing their ability to manage instability and sway, unlike traditional treatments that may not specifically target balance issues. ^{4 5 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Diabetic polyneuropathy may increase the handicap related to vestibular disease. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Mild diabetic neuropathy affects ankle motor function. [2022]

4. Pakistan 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dynamic stability training improves standing balance control in neuropathic patients with type 2 diabetes. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Getting the right balance: insole design alters the static balance of people with diabetes and neuropathy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Effect of Ankle-Foot Orthoses on Balance Impairment: Single-Case Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Spectral characteristics of postural sway in diabetic neuropathy patients participating in balance training. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effects of light fingertip touch on postural responses in subjects with diabetic neuropathy. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Postural performance assessment in aging people with diabetes and diabetic peripheral neuropathy using a Wii balance board. [2023]