Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients

NCT07598513 | Not Yet Recruiting

• 1 other identifier: TUF/EIRB/172/26
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is designed to compare the effectiveness of perturbation-based balance training performed on two different surfaces, stable (firm surface) and unstable (rolling board), for enhancing static, dynamic, and reactive balance in individuals diagnosed with diabetic neuropathy. This randomized clinical trial will recruit a total of 42 participants, with the sample size calculated using Epi Tool software. A consecutive sampling technique will be implemented. Eligible participants who fulfill the inclusion criteria will be randomly assigned into two equal groups (n = 21 each) through an online randomization method. Participants in Group A will undergo perturbation-based balance exercises on a stable surface, whereas participants in Group B will receive similar training on a rolling board to introduce surface instability. In addition to the primary intervention, both groups will receive contrast bath therapy as a standard baseline treatment. Written as well as verbal informed consent will be obtained prior to participation. The intervention protocol will span four weeks, consisting of three sessions per week on alternate days, resulting in a total of twelve treatment sessions. The primary outcomes will focus on balance performance and fall risk. These outcomes will be measured using the Berg Balance Scale, the Mini-Balance Evaluation Systems Test, and the Timed Up and Go test. Screening for diabetic neuropathy will be carried out using the Michigan Neuropathy Screening Instrument. Statistical analysis will be performed using SPSS version 23.

Conditions

Balance Impairment; Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Balance; Perturbation-Based Balance Training; Mini-BESTest; Michigan Neuropathy Screening Instrument

Outcome Measures

Primary Outcomes (1)

• Static and dynamic balance

  Static and dynamic balance will be measured using the standard Berg Balance Scale, a widely used clinical tool for assessing balance performance and fall risk. It consists of 14 functional tasks, including sitting, standing, reaching, turning, and transferring, with each item scored on a 5-point scale from 0 to 4. Higher total scores indicate better balance ability.

  Baseline and Week 4

Secondary Outcomes (2)

• Reactive balance

  Baseline and Week 4

• Risk of Fall

  Baseline and Week 4

Study Arms (2)

Group A (Perturbation Based Training on Firm Surface)

EXPERIMENTAL

Manual perturbations will be applied in four directions: right lateral, left lateral, forward, and backward. Training will be performed in progressive positions, starting from sitting, advancing to kneeling, and then to standing. Contrast bath therapy will be administered for a total duration of 20 minutes.

Other: Group A (Perturbation Based Training on Firm Surface)

Group B (Perturbation Based Training on Rolling Board)

ACTIVE COMPARATOR

Manual perturbations will be applied in multiple directions while the patient stands on a rolling board. During the procedure, the therapist will manually perturb the rolling board to challenge the patient's balance. Initially, the training will be conducted within parallel bars for safety and will later be progressed outside the bars as the patient's balance improves. The total duration of the treatment program will be four weeks. Contrast bath therapy will be administered for a total duration of 20 minutes.

Other: Group B (Perturbation Based Training on Rolling Board)

Interventions

Group A (Perturbation Based Training on Firm Surface) OTHER

Manual perturbations will be applied in four directions: right lateral, left lateral, forward, and backward. Training will be performed in progressive positions, starting from sitting, advancing to kneeling, and then to standing. Each session will include two sets of perturbation training, 5 minutes per set and a 10-second rest interval provided between successive perturbations. The intervention will be conducted three days per week on alternate days, with a total of 10 perturbations delivered per session. Total treatment time will be 45 minutes. Progression to more challenging positions will occur once the patient demonstrates adequate balance control following manual perturbations. The total duration of the treatment program will be four weeks. Contrast bath therapy will be administered for a total duration of 20 minutes. The protocol will involve immersion in cold water (60-70°F) for 1 minute followed by warm water (100-105°F) for 3 minutes, repeated for five cycles.

Group A (Perturbation Based Training on Firm Surface)

Group B (Perturbation Based Training on Rolling Board) OTHER

Manual perturbations will be applied in multiple directions while the patient stands on a rolling board. During the procedure, the therapist will manually perturb the rolling board to challenge the patient's balance. Each session will consist of two sets of training, with each set lasting 5 minutes and a 10-second rest interval between successive perturbations. The intervention will be performed three days per week on alternate days, with a total of 10 perturbations delivered per session. Each treatment session will last approximately 45 minutes. Initially, the training will be conducted within parallel bars for safety and will later be progressed outside the bars as the patient's balance improves. The total duration of the treatment program will be four weeks. Contrast bath therapy will be administered for a total duration of 20 minutes. The protocol will involve immersion in cold water (60-70°F) for 1 minute followed by warm water (100-105°F) for 3 minutes, repeated for five cycles.

Group B (Perturbation Based Training on Rolling Board)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a confirmed clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5%) (Bolen et al., 2016).
• Participants with a diabetes duration of more than 10 years (Grewal et al., 2015).
• Participants exhibiting signs and symptoms of diabetic peripheral neuropathy (such as numbness, tingling, burning, shooting or electric shock-like pain, and glove-and-stocking distribution), confirmed using the Michigan Neuropathy Screening Instrument with scores of 6-8 (patient version) and 2.5-4 (physical assessment) (Haque et al., 2022).
• Participants aged between 40 and 75 years (Rasool et al., 2024).
• Participants currently using insulin-sensitizing medications (e.g., metformin, Diamicron, insulin).
• Participants who are able to stand and walk independently (Allin et al., 2020).
• Participants with a Berg Balance Scale score ranging from 25 to 40 (Phyu et al., 2022).
• Participants willing to provide informed consent (Lepesis et al., 2023).

You may not qualify if:

• Patients with a confirmed diagnosis of benign paroxysmal positional vertigo (BPPV) will be excluded (Daud et al., 2021).
• Those with cognitive deficits (such as dementia or Alzheimer's disease) that may interfere with comprehension or compliance with study procedures will not be included (Hatton et al., 2019).
• Individuals presenting with foot drop or other neurological disorders (e.g., stroke, myelopathy, or cerebellar ataxia) that could affect the study findings will be excluded (Khurshid et al., 2025).
• Patients who have recently undergone surgery, sustained trauma to the feet or lower limbs, or have any foot amputation will not be eligible (Collings et al., 2023).
• Individuals diagnosed with deep vein thrombosis or orthostatic hypotension will be excluded (Khurshid et al., 2025).
• Patients with active diabetic foot ulcers or notable musculoskeletal deformities (such as scoliosis or degenerative joint disease) will be excluded (Lepesis et al., 2023).
• Individuals with neuropathy unrelated to diabetes, including cases associated with alcohol use or Charcot-Marie-Tooth disease, will not be included.
• Participants taking medications that may provoke vertigo or disturb balance (for example, aspirin) will be excluded.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (12)

• Phyu SN, Wanpen S, Chatchawan U. Responsiveness of the Mini-Balance Evaluation System Test in Type 2 Diabetic Patients with Peripheral Neuropathy. J Multidiscip Healthc. 2022 Dec 29;15:3015-3028. doi: 10.2147/JMDH.S392058. eCollection 2022.

  PMID: 36601428 BACKGROUND

• Nugraha MHS. Balance Problems in the Elderly with Diabetes Mellitus: A Literature Review. J Midlife Health. 2024 Apr-Jun;15(2):55-61. doi: 10.4103/jmh.jmh_29_23. Epub 2024 Jul 5.

  PMID: 39145265 BACKGROUND

• Lepesis V, Paton J, Rickard A, Latour JM, Marsden J. Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT. J Foot Ankle Res. 2023 Dec 6;16(1):88. doi: 10.1186/s13047-023-00690-4.

  PMID: 38057930 BACKGROUND

• Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.

  PMID: 40016658 BACKGROUND

• Jiang X, Deng F, Rui S, Ma Y, Wang M, Deng B, Wang H, Du C, Chen B, Yang X, Boey J, Armstrong DG, Deng W, Duan X. The Evaluation of Gait and Balance for Patients with Early Diabetic Peripheral Neuropathy: A Cross-Sectional Study. Risk Manag Healthc Policy. 2022 Mar 30;15:543-552. doi: 10.2147/RMHP.S361698. eCollection 2022.

  PMID: 35386278 BACKGROUND

• Hatton AL, Gane EM, Maharaj JN, Burns J, Paton J, Kerr G, Rome K. Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e026240. doi: 10.1136/bmjopen-2018-026240.

  PMID: 31320345 BACKGROUND

• Haleem F, Saeed A, Kundi M, Jalal A, Bilal M, Jalal M. Combined effects of strength and balance training versus aerobic training on balance, neuropathy symptoms and quality of life in patients with diabetic peripheral neuropathy. Physiother Res Int. 2024 Jul;29(3):e2103. doi: 10.1002/pri.2103.

  PMID: 38887171 BACKGROUND

• Grewal GS, Schwenk M, Lee-Eng J, Parvaneh S, Bharara M, Menzies RA, Talal TK, Armstrong DG, Najafi B. Sensor-Based Interactive Balance Training with Visual Joint Movement Feedback for Improving Postural Stability in Diabetics with Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2015;61(6):567-74. doi: 10.1159/000371846. Epub 2015 Feb 19.

  PMID: 25721132 BACKGROUND

• Collings R, Freeman J, Latour JM, Hosking J, Paton J. Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study. Pilot Feasibility Stud. 2023 Feb 3;9(1):20. doi: 10.1186/s40814-023-01252-y.

  PMID: 36737812 BACKGROUND

• Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.

  PMID: 36404857 BACKGROUND

• Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9.

  PMID: 32532221 BACKGROUND

• Daud SAH, Rahman MU, Arsh A, Junaid M. Effect of balance training with Biodex Balance System to improve balance in patients with diabetic neuropathy: A quasi experimental study. Pak J Med Sci. 2021 Mar-Apr;37(2):389-392. doi: 10.12669/pjms.37.2.2336.

  PMID: 33679919 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Dr Maryam Safdar, MS (MSK)

  The University of Faisalabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Safdar Dr, MS Physical Therapy (MSK)

CONTACT

+92-3217978088; maryamsafdar.DPT@tuf.edu.pk

Dr Muhammad Ateeb, PhD Public Health

CONTACT

+92-3357333383; mateeb.oric@tuf.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study in which participants are unaware of their group allocation. The Group A and B receive identical-appearing interventions. Allocation is concealed from participants but known to the investigators and data analysts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study followed a parallel group randomized clinical trial design. Patients diagnosed with diabetic neuropathy will first be screened using by screening form . Those who fulfill the inclusion criteria will be included, and both written and verbal informed consent will be obtained. A total of 42 eligible participants will be enrolled and randomly assigned into two equal groups (n = 21 each) using an online randomization method. The primary study outcomes will be balance (Static and dynamic) and secondary will be reactive balance and risk of falls, which will be evaluated using the Berg Balance Scale, Mini-Balance Evaluation Systems Test and Timed Up and Go test. Participants in Group A will receive perturbation-based training on a firm surface, whereas Group B will undergo the same on a rolling board. Contrast bath therapy will be used as a baseline intervention. Total intervention time will be four weeks, with three sessions per week.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)