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NCT Number: NCT07394504

Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Additionally, individuals with DPN are at heightened risk for mild cognitive impairment (MCI), which further compromises functional independence. This study aims to determine the effects of turning-based dual-task training compared to conventional dual-task training on balance, cognitive function, and fall risk in individuals with DPN. Pre- and post-intervention assessments will be conducted using the Berg Balance Scale (BBS), Montreal Cognitive Assessment (MoCA), and Timed Up and Go Test (TUGT) to evaluate balance, cognition, and fall risk respectively.

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Key information

Conditions

Diabetic Neuropathy Balance Cognition Disorders Cognitive Decline Cognitive Dysfunction Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

About this study

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. As a major global health concern, its prevalence has been steadily increasing. According to the recent searches, 26.7% of adults in Pakistan are affected by diabetes. Implicated poor glycemic control, duration of diabetes, hyperlipidemia (particularly hypertriglyceridemia), elevated albumin excretion rates and obesity as risk factors for the development of DPN. This study aims to explore the effectiveness of these interventions in this specific population and to tell a treatment that will target both balance and cognition that will be used for DPN patients to improve the symptoms.

A randomized controlled trial will be conducted over one year. 44 participants will be selected through non- probability purposive sampling and randomly divided into two groups. The intervention will last eight weeks, comprising 24 treatment sessions. Assessments will be conducted at baseline and at the end of eight week. Treatment for Group A will include warm up, conventional balance training, turning based dual task training followed by cool down. Group B will include warm up, conventional balance training, dual task training followed by cool down.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes Mellitus ≥ 5 years
  • Diagnosed with Diabetic Peripheral Neuropathy
  • Age 50 and above
  • Berg Balance Scale (BBS 21-40) score
  • Mild Cognitive Impairments (MoCA 18-25)
  • Able to stand and walk with or without assistive devices

Exclusion criteria

  • Severe neuropathic foot ulcers or Charcot joints.
  • History of major musculoskeletal injuries affecting ambulation (Fractures of lower limb), Severe Osteoarthritis.
  • Uncontrolled Diabetes.
  • Neurological disorders unrelated to DPN (brain tumors, stroke, epilepsy, Alzheimer's, GBS and Parkinson's disease).
  • Significant visual, auditory impairment.

Treatment and study plan

Turning Based Dual Task Training

Procedure

Intervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down.

Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing.

Turning protocol will be in three progressive phases. Phase 1 will include turning around cone, obstacles, during walking and 8 figure walk with cognitive dual task( name animals, shapes etc). Phase 2 exercises are 360 turn, sudden turn, stepping with turn, 8 figure turn and obstacle turn with more cognitive load. Phase 3 exercises are all exercises above in tandem walk with reaching activites and more cognitive load.

Dual-Task Training

Procedure

Intervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down.

Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing.

This protocol will be in three progressive phases. Phase 1 will include sit to stand, dynamic weight shifting (standing), stepping, walking in multi direction with cognitive task like name countries, sentence completion etc. Phase 2 will include additional step over low obstacle in walking along the above exercises with more repetitions and increased cognitive load.

Phase 3 will include tandem walk, step over high obstacle, ball throw/catch, multi direction walk in tandem with more increased cognitive load respectively.

Primary outcomes

  1. Balance

    Time frame: 8 weeks

    Balance is assessed by Berg Balance Scale. Interpretations: mild=41-56,moderate=21-40,severe=0-20

  2. Cognition

    Time frame: 8 weeks

    MoCA will be used for mild cognitive impairment. Interpretations: Mild= 18-25, Moderate=10-17, Severe=0-9

  3. Fall Risk

    Time frame: 8 weeks

    Timed up and go test will be used for Fall Risk. Interpretations: Low Risk: <10 seconds, Moderate Risk: 10-19 seconds, High Risk: ≥ 14-20 seconds, Severe Risk: > 30 seconds

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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