An interventional study of Perturbation-Based Balance Training (PBBT) and Conventional Balance Training (CBT) in Diabetic Peripheral Neuropathy, sponsored by Lahore University of Biological and Applied Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Lahore University of Biological and Applied Sciences · Not applicable, Interventional, and Treatment
This study will compare perturbation-based balance training (PBBT) with conventional balance training in patients with diabetic peripheral neuropathy to assess reactive stepping ability, dynamic balance, and functional balance. Diabetic peripheral neuropathy is a prevalent complication of type 2 diabetes, affecting nearly 43% of diabetic patients in Pakistan. As a progressive condition, it leads to peripheral sensory loss, proprioceptive deficits, and delayed neuromuscular responses, all of which compromise balance and postural control and place this population at significantly elevated risk of falls.
In this study, a total of 40 adults with DPN will be randomly allocated into two groups: PBBT and CBT. Both groups will receive a total of 24 sessions with 3 supervised sessions per week for 8 weeks. The PBBT group will receive manually delivered, repeated, unexpected perturbations by a physical therapist. The CBT group will receive conventional balance training without perturbations. Outcome measures will include reactive stepping (Lean-and-Release Test), dynamic balance (Mini-BESTest), and functional balance (Berg Balance Scale). The assessment will be done at baseline, post-intervention (Week 8), and follow-up (Week 12). The study aims to determine which intervention provides superior improvement in reactive stepping and balance in patients with diabetic peripheral neuropathy.
Diabetic peripheral neuropathy (DPN) is one of the most prevalent complications of diabetes mellitus, contributing substantially to disability worldwide. As a progressive condition, DPN leads to peripheral sensory loss, proprioceptive deficits, and delayed neuromuscular responses, all of which compromise balance and postural control. Because reactive stepping depends on rapid, sensory-driven neuromuscular responses, this progressive sensory and motor decline delays the reactive stepping response required to arrest a fall, placing this population at significantly elevated risk of falls and fall-related injury. Current rehabilitation approaches have not adequately addressed this specific deficit. A review demonstrates that conventional balance training predominantly improves static and anticipatory balance, as it relies on predictable, self-initiated movements. However, these gains fail to transfer to the unpredictable, real-world balance challenges that precipitate most falls, since conventional protocols do not expose patients to the rapid, feedback-driven corrections that reactive stepping demands. This represents a critical limitation a need for an intervention that trains balance in controlled conditions. But it leaves the reflexive, protective response untrained while this mechanism is most directly implicated in fall prevention.
Perturbation-based balance training (PBBT) has emerged as a promising alternative, grounded in principles of neuroplasticity. It has shown effectiveness in retraining reactive postural responses across several neurological populations. Despite this, evidence evaluating its effectiveness specifically on reactive stepping in individuals with DPN remains limited.
Thus, the existing literature reveals a clear and clinically consequential gap as balance training interventions in DPN have been shown to improve anticipatory postural control and static balance. The reactive stepping, which is the last line of defense against falls during unexpected perturbations, remains largely untrained and underexplored. This study therefore aims to address this gap by evaluating the effectiveness of PBBT in enhancing reactive stepping ability in individuals with diabetic peripheral neuropathy. This study is designed as a two-arm, parallel-group randomized clinical trial to compare the effects of PBBT and CBT on reactive stepping ability, dynamic balance, and functional balance in individuals with DPN. A total of 40 participants will be recruited and randomly allocated into either the PBBT group or the CBT group in a 1:1 ratio using a computer-generated randomization sequence with allocation concealment through sequentially numbered, opaque, sealed envelopes (SNOSE). Participants in both groups will receive intervention for 8 weeks, with 3 supervised sessions per week, making a total of 24 sessions. Each 60-minute session will include 20 minutes of routine physical therapy (7 minutes of warm-up, 6 minutes of rest, and 7 minutes of cool-down) and a main intervention of 40 minutes. All participants will first receive an equal standardized baseline treatment for 2 weeks. Following this, from week 3 to week 8, the PBBT group will receive manually delivered repeated exposure to unexpected and externally imposed postural perturbations by a physical therapist in a standing position on stable and unstable surfaces, while the CBT group will receive balance training with eyes open and eyes closed in various conditions on stable and unstable surfaces, with no manual perturbations. Sessions will be delivered under safety procedures, including a support bar during perturbation tasks and pre-session blood glucose monitoring. Outcome measures will include reactive stepping ability assessed using the Lean-and-Release Test (primary outcome), dynamic balance assessed using the Mini-BESTest, and functional balance assessed using the Berg Balance Scale. Participants will be screened for DPN using the Michigan Neuropathy Screening Instrument (MNSI). Assessments will be conducted at baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12) by a blinded outcome assessor. The findings of this study will provide comparative evidence regarding the effectiveness of PBBT and CBT in improving reactive stepping and balance in individuals with DPN. Because the proposed intervention requires only basic rehabilitation equipment, it may offer a practical, cost-effective, and scalable rehabilitation approach for reducing falls in resource-limited settings and may assist clinicians in selecting the most appropriate balance training approach for this patient population.
Lahore University of Biological and Applied Sciences is the lead sponsor of 79 studies on the registry; 55 are open to participants now.
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Arm Description: Group A will receive routine physical therapy along with perturbation-based balance training. After a 2-week shared familiarization phase (weeks 1-2), participants will receive manually delivered, repeated exposure to unexpected and externally imposed postural perturbations by a physical therapist in a standing position on stable and unstable surfaces (weeks 3-8). Sessions will be delivered 3 times per week for 8 weeks (24 sessions, 60 minutes each).
Behavioral: Perturbation-Based Balance Training (PBBT)
Group B will receive routine physical therapy along with conventional balance training. After a 2-week shared familiarization phase (weeks 1-2), participants will be trained for balance with eyes open and eyes closed in various conditions on stable and unstable surfaces, with no manual perturbations (weeks 3-8). Sessions will be delivered 3 times per week for 8 weeks (24 sessions, 60 minutes each).
Behavioral: Conventional Balance Training (CBT)
Participants will receive routine physical therapy (7 minutes of warm-up, 6 minutes of rest, and 7 minutes of cool-down) along with perturbation-based balance training for 8 weeks, with 3 supervised sessions per week (24 sessions, 60 minutes each). After a 2-week shared familiarization phase (weeks 1-2), participants will receive manually delivered, repeated exposure to unexpected and externally imposed postural perturbations by a physical therapist in standing position on stable and unstable surfaces (weeks 3-8). Perturbations will progress from anterior and posterior to multi-directional and randomized, and from standing tasks to walking, uneven surfaces, and dual-task conditions, increasing from 10 to 15 perturbations per session. A support bar and pre-session blood glucose monitoring will be used for safety.
Participants will receive routine physical therapy (7 minutes of warm-up, 6 minutes of rest, and 7 minutes of cool-down) along with conventional balance training for 8 weeks, with 3 supervised sessions per week (24 sessions, 60 minutes each). After a 2-week shared familiarization phase (weeks 1-2), participants will be trained for balance with eyes open and eyes closed in various conditions on stable and unstable surfaces, with no manual perturbations (weeks 3-8). Training will progress from foam-pad standing and weight shifting to functional gait tasks, obstacle negotiation, stair negotiation, and dual-task walking. A support bar and pre-session blood glucose monitoring will be used for safety.
Reactive stepping ability (Lean-and-Release Test)
The Lean-and-Release Test (LRT) will be used to assess reactive stepping ability. Participants stand barefoot in a standardized position and lean forward while the assessor supports them at the waist, bearing approximately 8-12% of their estimated body weight. The assessor then suddenly withdraws support, creating an unexpected forward perturbation that requires a rapid compensatory step. Each session consists of one unscored familiarization trial followed by 13 test trials (10 released trials and 3 false trials). The primary outcome is the proportion of successful single-step recovery trials out of the 10 released trials, with a higher proportion indicating better reactive stepping performance. The mean number of recovery steps across the 10 released trials will also be recorded, with a lower mean indicating greater reactive stepping efficiency.
Time frame: Baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12)
Dynamic balance (Mini-BESTest)
The Mini-Balance Evaluation Systems Test (Mini-BESTest) assesses reactive postural control, anticipatory postural adjustments, sensory orientation, and dynamic gait stability. It has 14 items, each scored 0 to 2, with a maximum score of 28. Higher scores indicate better balance performance and lower fall risk, and a score below 20 commonly indicates increased fall risk.
Time frame: Baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12)
Functional balance (Berg Balance Scale)
The Berg Balance Scale (BBS) assesses static and anticipatory balance during functional tasks such as standing, turning, reaching, and transferring. It has 14 items, each scored 0 to 4, with a maximum score of 56. Higher scores indicate better functional balance, and scores below 45 suggest increased fall risk.
Time frame: Baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12)
Plan to share: No
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Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
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Lahore University of Biological and Applied Sciences