An interventional study of Reactive Balance Training and TASK ORIENTED TRAINING in Diabetic Neuropathies, Rehabilitation and Reaction Time, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
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.
Diabetic peripheral neuropathy (DPN) is a common complication, resulting from prolonged high blood sugar damaging peripheral nerves. It substantially affects patients by increasing their risk of falls, impairing sensory function, and diminishing overall quality of life. Exercise programs that include balance training have demonstrated promising results in enhancing postural stability and reducing fall risk among patients with DPN .By engaging the visual, vestibular, and proprioceptive systems, balance training facilitates central nervous system adaptation, enhancing the integration of sensory inputs critical for maintaining postural control.This randomized controlled trial aims to compare the effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients with Diabetic Peripheral Neuropathy.The study will be a single -blinding randomized controlled trial, consisting of 2 groups and it will be conducted over a period of 1 year at Foundation University and Collage of Physical Therapy. A calculated sample of 36 subjects will be selected via convenience sampling technique followed by randomization into two groups using coin toss method. Ethical approval will be obtained from FUSH ERC. Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Postural stability will be assessed using Posture Assessment Checklist Form, MiniBestest, Funtional Reach test and Time Up and Go in both group.
Each group will have 30-40 minutes divided into 5-7 minutes of warm-up and 20-30 minutes of Reactive balance training or task-specific depending on the group the patient is assigned to follow by 5 minutes cool down period. With every 3 sets or 8-10 repetitions patient will take a 60 seconds break. The total intervention duration will last for 6 weeks. The total number of sessions will be 18 with 3 sessions per week. Each session will begin with a 5-7-minute warm-up consisting of marching in place, ankle pumps and circles, and anterior-posterior (AP) and medial-lateral (ML) weight shifts. This will be followed by 20-30 minutes of group-specific training, with the Reactive Balance Training group performing perturbation-based tasks involving unexpected changes in direction, timing, or surface, while the Task-Oriented Training group will perform functional, goal-directed activities with repetitive practice and progressive challenges.
Each session will conclude with a 5-minute cool-down, including slow walking and stretching of the calf, hamstrings, and hip flexors. Group A will receive reactive balance training with Protocol of 6 Weeks.
In Weeks 1-2 - Familiarization: Warm-up (5-7 min), followed by lean-and-release (forward/backward), gentle AP pelvic perturbations, predictable reactive stepping, and elastic-band perturbations in AP/lateral directions. Cool-down (5 min). Dosage: 3 × 10 perturbations, 60-s rest.
In Weeks 3-4 - Adaptation: Multidirectional lean-and-release, eyes-closed perturbations, foam-surface perturbations, foam + elastic-band perturbations, and eyes-closed elastic perturbations. Dosage: 3 × 10 trials, 60-s rest.
In Weeks 5-6 - Functional/Automatic Phase: High-velocity manual perturbations with narrow/tandem stance, reactive stepping during gait, obstacle negotiation with perturbation, and dual-task reactive balance (counting backward while walking). Dosage: 3 × 10 repetitions, 60-s rest.Safety: Gait belt, therapist guarding, stable support, and appropriate elastic-band use throughout.
Group B will receive Task oriented training of 6 weeks protocol with Weeks 1-2 - Basic Functional Task Acquisition: The objective is to improve postural alignment and basic functional mobility. Participants will perform sit-to-stand from a standard chair, static standing with functional reaching, weight shifting while reaching, forward and lateral stepping, and supported heel-to-toe standing. Dosage: 3 sets × 10 repetitions per task, with 60-second rest.
Weeks 3-4 - Intermediate Functional Task Training: The goal is to enhance dynamic balance and functional independence through sit-to-stand from a low chair, reaching beyond arm's length, multidirectional stepping, obstacle crossing during gait, and step-ups. Difficulty will progress by reducing upper-limb support and increasing task speed and repetitions. Dosage: 3 × 10 repetitions, 60-second rest.
Weeks 5-6 - Advanced \& Real-Life Task Integration: Activities will include carrying objects during sit-to-stand, dual-task walking, turning/pivoting, obstacle negotiation with load carrying, and simulated ADL tasks. Progression will involve a narrow base of support and increased task complexity and environmental variability. Dosage: 3 × 10 repetitions, 60-second rest.
Baseline assessment will be taken at the time of recruitment using MiniBestest, FRT ,TUG tool and Posture Assessment checklist form. Another assessment at 3rd week will be taken and lastly, post intervention assessment will be done by the end of 6th week using the same tools as mentioned previously. Data will be analyzed using SPSS version 22.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
This study's planned enrollment of 36 is below the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
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Exclusion Criteria:
Participants will receive reactive balance training focused on improving rapid postural responses to unexpected balance disturbances through controlled external perturbations during standing and walking, emphasizing ankle, hip, and stepping strategies with progressive difficulty.
Procedure: Reactive Balance Training
Participants will receive task-oriented training consisting of functional, goal-directed activities such as sit-to-stand, reaching, stepping, walking with direction changes, obstacle negotiation, and weight-shifting, with gradual progression in task complexity
Procedure: TASK ORIENTED TRAINING
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
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.
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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
Time frame: 6 weeks
Started Feb 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.
Of 137 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 10 months is close to that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 28.
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