NCT07394504

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

January 30, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Dual-task trainingDual-task Exercises

Outcome Measures

Primary Outcomes (3)

  • Balance

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

    8 weeks

  • Cognition

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

    8 weeks

  • Fall Risk

    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

    8 weeks

Study Arms (2)

Turning Based Dual-Task Training

EXPERIMENTAL

Group A receives Turning Based Dual-Task Training: The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down.

Procedure: Turning Based Dual Task Training

Dual-Task Training

EXPERIMENTAL

Group B receives Dual-Task Training: The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down.

Procedure: Dual-Task Training

Interventions

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.

Turning Based Dual-Task Training

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.

Dual-Task Training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetic NeuropathiesCognitive Dysfunction

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

November 20, 2025

Primary Completion

March 10, 2026

Study Completion

May 5, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations