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RECRUITING Not applicable ClinicalTrials.gov

Comparative Effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients With Diabetic Peripheral Neuropathy

Sponsor: Foundation University Islamabad • ClinicalTrials.gov ID: NCT07827417

Registry updated: 2026-09-18
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Description

Diabetic peripheral neuropathy (DPN) is a common complication of prolonged hyperglycemia that damages peripheral nerves, leading to impaired sensory function, increased fall risk, and reduced quality of life. Balance training has shown promising effects in improving postural stability and reducing fall risk in individuals with DPN by engaging visual, vestibular, and proprioceptive systems and promoting central nervous system adaptation. This randomized controlled trial aims to compare the effects of Reactive Balance Training (RBT) and Task-Oriented Training (TOT) on postural stability in patients with DPN. The study will be a single-blinded, two-group randomized controlled trial conducted over one year at Foundation University College of Physical Therapy. A sample of 36 participants will be recruited through convenience sampling and randomly allocated into two groups using the coin-toss method. Ethical approval will be obtained from the FUSH ERC, and written informed consent will be obtained after explaining the study procedures, risks, and benefits. Postural stability will be assessed using the Posture Assessment Checklist, Mini-BESTest, Functional Reach Test (FRT), and Timed Up and Go (TUG). Group A will receive RBT, while Group B will receive TOT. Each session will last 30-40 minutes, including a 5-7-minute warm-up, 20-30 minutes of group-specific intervention, and a 5-minute cool-down. Participants will receive 60-second rest intervals after every three sets or 8-10 repetitions. The intervention will continue for six weeks, with three sessions per week, totaling 18 sessions. Assessments will be conducted at baseline, at week 3, and post-intervention at week 6 using the same outcome measures.

Interventions

  • Reactive Balance Training (Procedure)
    Participants will be briefed about the study objectives, procedures, risks, and benefits. After informed consent, participants will be randomly allocated into two groups using the coin-toss method. Group A will receive Reactive Balance Training (RBT) to improve rapid postural responses to unexpected disturbances through progressive external perturbations during standing and walking, emphasizing ankle, hip, and stepping strategies. Weeks 1-2 (Familiarization): warm-up (5-7 min), lean-and-release, gentle AP pelvic perturbations, predictable reactive stepping, and AP/lateral elastic-band perturbations, followed by a 5-min cool-down. Weeks 3-4 (Adaptation): multidirectional lean-and-release, eyes-closed and foam-surface perturbations, and foam/elastic-band exercises. Weeks 5-6 (Functional): high-velocity perturbations, reactive stepping during gait, obstacle negotiation, and dual-task balance. All phases: 3 × 10 trials, 60-s rest, with gait belt, therapist guarding, and stable support
  • TASK ORIENTED TRAINING (Procedure)
    Group B will receive a 6-week Task-Oriented Training protocol. Weeks 1-2 (Basic Functional Task Acquisition): sit-to-stand, functional reaching, weight shifting, forward/lateral stepping, and supported heel-to-toe standing to improve postural alignment and mobility. Weeks 3-4 (Intermediate Training): low-chair sit-to-stand, reaching beyond arm's length, multidirectional stepping, obstacle crossing, and step-ups, with reduced upper-limb support and increased speed. Weeks 5-6 (Advanced/Real-Life Integration): sit-to-stand while carrying objects, dual-task walking, turning/pivoting, obstacle negotiation with loads, and simulated ADLs, progressing complexity and environmental variability. All phases will use 3 × 10 repetitions with 60-second rest. Baseline postural stability will be assessed using the Mini-BESTest, Functional Reach Test (FRT), Timed Up and Go (TUG), and Posture Assessment Checklist.

Eligibility criteria

Inclusion Criteria: * Both gender * Adults aged 40 years and above diagnosed with type 2 diabetes mellitus. * Diagnosed cases diabetic peripheral neuropathy. * Able to stand and walk independently * Balance or postural stability, as indicated by clinical tests (e.g., mini-bestest score below -normative values/21 or less or history of falls/near-falls). * Functional reach test with scores 6-10 inches * Time up and go up to 14 seconds Exclusion Criteria: * History of neurological disorders other than DPN (e.g., stroke, Parkinson's disease, multiple sclerosis). * Musculoskeletal disorders affecting lower limb function (e.g., grade 4 osteoarthritis, recent fractures). * Uncontrolled cardiovascular conditions (e.g., unstable angina, recent myocardial infarction). * Vestibular impairments affecting balance independently of DPN. * Diabetic complications that contraindicate exercise (e.g., active foot ulcers, severe retinopathy).

Conditions

Diabetic Neuropathies Rehabilitation Reaction Time Activities of Daily Living Postural Balance Physiology Accidental Falls

Locations

  • Foundation University College of Physical Therapy — Islamabad, Pakistan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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