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

NCT07827417 | Recruiting

• 1 other identifier: FUI/FUCP/CTR/Neuro/HifzaSafdar
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

REACTIVE BALANCE TRAINING; TASK ORIENTED TRAINING; POSTURAL STABILITY; DIABETIC PERIPHERAL NEUROPATHY

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  6 weeks

Study Arms (2)

Group A- REACTIVE BALANCE TRAINING

EXPERIMENTAL

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

TASK ORIENTED TRAINING

EXPERIMENTAL

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

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

Group A- REACTIVE BALANCE TRAINING

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.

TASK ORIENTED TRAINING

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hifza Safdar, DPT

CONTACT

+923230501443; hifzasafdar482@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

PA (1)