About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Reactive Balance Training
Procedure/SurgeryParticipants 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/SurgeryGroup 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.
Treatment groups
Trial outcomes
Primary outcomes
Postural stability
Postural stability during Reactive Balance will be assessed using MiniBestest test in both groups. The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. If a subject must use an assistive device for an item, score that item one category lower. If a subject requires physical assistance to perform an item, score "0" for that item. For Item 3 (stand on one leg) and Item 6 (compensatory stepping-lateral) only include the score for one side (the worse score). For Item 3 (stand on one leg) select the best time of the 2 trials \[from a given side\] for the score. For Item 14 (timed up \& go with dual task) if a person's gait slows greater than 10% between the TUG without and with a dual task then the score should be decreased by a point.
Functional Postural stability
Functional postural stability will assess using Functional Reach Test. Use to measure ability to maintain stability while reaching forward and controlling the center of mass. * If the reach distance exceeds 25.40 cm, it is considered a negative test and a low risk of falling. * If the reach distance is within the range of 15.24-25.40 cm, the risk of falling is twice as high during the next six months. * If the reach distance is less than 15.24 cm, there is a four times greater risk of falling during the next six months.
Dynamic Postural Stability
Dynamic Postural Stability will be assess using TIME UP \& GO. A TUG time of ≤10.7 seconds indicates better functional mobility and lower fall risk, whereas a time of \>10.7 seconds indicates poorer functional mobility and increased fall risk in individuals with diabetic peripheral neuropathy. Posture Assessment Checklist will be use as well in order to check the anterior, posterior and lateral view of posture for ruling out any kind of deformity
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